What Are the Immediate Effects of Passive Hip Joint Mobilization on Hip Abductor/External Rotator Muscle Strength in Patients With Anterior Knee Pain and Impaired Hip Function
Phase: NA
Conditions: Anterior Knee Pain Syndrome, Patellofemoral Pain Syndrome
Sponsor: Sheffield Hallam University

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MA/MBA/MSc Dissertation Proposal Form for 
Health and Social Care Subjects 
 
FACULTY OF HEALTH AND WELLBEING 
 
 
RESEARCH PROJECT 
 
 
 
STUDENT NAME:  
 
STUDENT NUMBER: 
 
PFLÜGLER GEORG 
 
 
 
 
 
       26020250 
 
Contents: 
 
Proposal 
 
 
 
Risk assessment form 
 
 
 
 
 
 
 
 
 
 
 
 
 
HERE provide a very brief (maximum 100 words) overview of study: Who/what is involved, data collec-
tion, data analysis methods and outcomes?  
 
The aim of the study is to assess the immediate effects of passive hip joint mobilisation (in comparison 
to a sham mobilisation) on eccentric hip abductor/external rotator muscle strength on the basis of 
manual muscle testing with a hand-held-dynamometer within a cross-over study design. Patients with 
anterior knee pain and signs of impaired hip function will be recruited in Vienna and surrounding area, 
measurements/data collection will be conducted in a physiotherapy group practice in 1150 Vienna. 
Data will be analysed with the Stata/IC15.1 software using descriptive statistics prior to further infer-
ential statistics (independent group t-tests). The values of the primary outcome measure (torque 
measurements) will be normalized by the body mass of each participant. 
 
 
 

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MA/MBA/MSc Dissertation Proposal  
Registration of Project 
 
FACULTY OF HEALTH AND WELLBEING 
 
 
Complete all sections as appropriate 
 
 
 
STUDENT NAME: 
 
Pflügler Georg 
 
STUDENT NUMBER: 
 
26020250 
 
COURSE: 
 
MSc Manual Therapy 
 
PROJECT TITLE: 
The immediate effects of passive hip joint mobilization on hip abductor/external rotator 
muscle strength in patients with anterior knee pain and impaired hip function 
PROPOSED 
START: 
 
October 2018 
 
CREDIT POINTS: 
 
 
PROPOSED COM-
PLETION: 
 
April 2019 
 
TYPE OF PROJECT: 
 
RESEARCH 
ACADEMIC 
SUPERVISOR: 
 
Sionnadh McLean 
 
 
 

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Proposal dissertation 
 
Principal Research Question 
What are the immediate effects of passive hip joint mobilization on hip abductor/external ro-
tator muscle strength in patients with anterior knee pain and impaired hip function? 
Null Hypothesis 
There are no immediate effects of passive hip joint mobilization on hip abductor/external ro-
tator muscle strength in patients with anterior knee pain and impaired hip function. 
Experimental Hypothesis: 
There are immediate (positive) effects of passive hip joint mobilization on hip abductor/exter-
nal rotator muscle strength in patients with anterior knee pain and impaired hip function. 
 
Justification for research project 
Anterior knee pain (AKP) is one of the most frequent reasons for consultation in the context of 
knee conditions in young adults, especially when they participate in sports (Foss, Hornsby, 
Edwards, Myer, & Hewett, 2012). Boling et al. (2010) found an AKP prevalence of 15% in 
females and 12% in males, similarly, Nejati et al. (2011) found the prevalence rate to be 16.7%. 
Nevertheless, despite its high prevalence, the treatment of AKP is often not successful. Col-
lins et al. (2012) analyzed 4 conservative intervention protocols, and they revealed that 40% 
of these patients had an unfavourable recovery at 12 months after the initial diagnosis. More-
over, AKP is rarely a self-limiting condition; it is recurrent or chronic in between 70% and 90% 
of the cases (Powers, Bolgla, Callaghan, Collins, & Sheehan, 2012). Since AKP frequently 
occurs in young working adults, it has an important societal impact due to work absences as 
well as due to the economic expense involved in the treatment of these patients (Tan et al., 

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2010). Moreover, these AKP patients may also have an increased risk of developing patello-
femoral osteoarthritis (K. M. Crossley, 2014). In summary, the high prevalence of AKP along 
with poor long-term prognosis and high disability levels, turns this clinical entity into an urgent 
research priority. In fact, the Chartered Society of Physiotherapy in the UK has ranked AKP as 
the third most important topic (out of 185) in their Musculoskeletal Research Priority Project 
(Rankin, Rushton, Olver, & Moore, 2012), which is a further indicator of its research im-
portance.  
The aetiology of AKP is typically multifactorial, involving local, proximal and distal factors. 
Hence, there is no single right treatment, the treatment approach has to be tailored to the 
individual patient (Sanchis-Alfonso, McConnell, Monllau, & Fulkerson, 2016). However, in re-
cent years much attention has been paid to the relationship between hip function and AKP. It 
is proposed that greater hip adduction and internal rotation, especially during weight-bearing 
activities, may lead to altered knee and patellofemoral joint kinematics and therefore present 
a potential risk factor for AKP development. Recent prospective studies support this hypothe-
sis (Boling et al., 2009; Noehren, Hamill, & Davis, 2013). These altered movement patterns 
may result from impaired gluteal hip muscle function. In fact, many studies have associated 
AKP with the weakness of hip abductors, external rotators and hip extensors (Niemuth, John-
son, Myers, & Thieman, 2005; Prins & Van Der Wurff, 2009; Rathleff, Rathleff, Crossley, & 
Barton, 2014). Further, reduced hip joint range of motion (ROM) has been associated with 
AKP as well (Hamstra-Wright, Earl-Boehm, Bolgla, Emery, & Ferber, 2017).  
In line with this evidence (that impaired hip muscle function is associated with AKP), Santos 
et al. (2015) have explored the clinical effects of hip strengthening programmes in their recent 
systematic review. Their results showed that hip muscle strengthening has an important role 
in the treatment of AKP patients, since this intervention is effective in reducing pain intensity 
and improving function. However, findings regarding the treatments’ ability to improve muscle 
strength were equivocal. One reason that may explain this result is the fact that neuromuscular 
activation deficits may be the underlying mechanism for the persistent muscle weakness, and 

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therefore hip strengthening programmes will be ineffective, as long as the activation deficit is 
not targeted first.  
Pietrosimone, Hopkins and Ingersoll (2008) proposed a new rehabilitation paradigm that rec-
ommends the previously stated: targeting neuromuscular activation deficits with the aid of dis-
inhibitory interventions prior to traditional strength training to enhance rehabilitation outcomes. 
They argue that if musculature is inhibited, for example due to arthrogenous muscle inhibition 
(AMI = a continued reflex inhibition of musculature caused by a pathological joint, where de-
spite intended maximal muscle contraction even unimpaired muscles are not able to fully ac-
tivate (Hopkins and Ingersoll, 2000)), without prior reengagement of the inhibited motor neu-
rons, suboptimal motor recruitment patterns could lead to decreased level of performance, 
increased rate of fatigue, increased risk of subsequent injury and increased risk of chronic 
dysfunction. 
In recent years, AMI has been primarily studied in the quadriceps muscles following acute 
knee joint injuries, operations or experimentally induced joint effusion (Freeman, Mascia, & 
McGill, 2013). However, Freeman et al. (2013) investigated and confirmed the existence of 
AMI in the hip joint as well, by showing that intra-articular injection of fluid causes diminished 
gluteal activation at functional hip extension tasks. Since patients with AKP show persistent 
gluteal hip weakness in common with reduced hip ROM and impaired hip kinematics, it may 
be hypothesized, that AMI of the hip joint may play a significant role in the treatment of these 
patients. 
In the literature (Gabler, Lepley, Uhl, & Mattacola, 2016; Rice & McNair, 2010), transcutaneous 
electrical nerve stimulation (TENS) and cryotherapy are recommended as the most promising 
facilitatory modalities. Manual therapy (passive joint mobilisation/manipulation) as possible 
falicitatory intervention on the other hand shows contradictory findings (Harkey, Gribble, & 
Pietrosimone, 2014; Pietrosimone et al., 2015). Reasons for this contradiction may be caused 
by the selected study designs, where the explored manual therapy techniques often do not 
seem to be the most appropriate (and clinically reasoned) choice for the respective patient 

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population. For example, Grindstaff et al. (2012) examined the effect of lumbopelvic manipu-
lation on quadriceps activation capacity in patients with AKP (but without present lumbopelvic 
impairments) and found that there was no immediate effect.  However, one rationale behind 
passive mobilisation as a disinhibitory intervention is the stimulation of sensory receptors in 
and around the joint in order to modulate altered joint afferent discharge and thereby disinhib-
iting the musculature surrounding this joint (Bialosky, Bishop, Price, Robinson, & George, 
2009). Therefore, in patients with AKP, the examination of the effect of peripheral knee joint 
mobilisation on quadriceps activation may have been more meaningful, when the knee as 
source for the inhibition is suspected. However, currently there are no such studies examining 
the effect of passive knee joint mobilisation on quadriceps muscle strength. On the other hand, 
two studies (Makofsky et al., 2007; Yerys, Makofsky, Byrd, Pennachio, & Cinkay, 2002)  have 
explored the effect of passive hip mobilisation on gluteal muscle strength in healthy subjects. 
They have shown a significant facilitatory effect, suggesting greater and clinically more rele-
vant effect may be possible in patients with persistent muscle weakness. For this reason the 
proposed study will explore the effect of a hip joint mobilisation on its inhibited surrounding 
musculature (namely hip ABD/ER) in a patient population (AKP patients with impaired hip 
function) with present persistent weakness. I expect that findings from this study may be rele-
vant for the prevention of chronification in AKP patients as well as in the development of treat-
ment strategies for patients suffering from multiple lower extremity joint pathologies that exhibit 
neuromuscular deficits. 
 
Research design: 
The design of the proposed study at hand will be similar to the works of Yerys et al. (2002) 
and Makofsky et al. (2007). Both examined the immediate effect of hip mobilisation on gluteal 
muscle strength in the form of a 'Pre-Test Post-Test equivalent group design'. Beside some 
changes in procedure and equipment being used, the most crucial contrasts between this 
proposed study and the previously mentioned works will lie in a different study population 

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(patients instead of healthy subjects) and study design (this study will use a cross-over de-
sign). Since the patients in a crossover trial serve as their own control, an advantage of using 
this design is the requirement of lower sample sizes compared to parallel-group trials to meet 
the same criteria in terms of type I and type II error risks (Wellek & Blettner, 2012).  
Methods 
Subjects: 
AKP is frequently defined as retropatellar or peripatellar pain, of more than three months du-
ration, in the absence of intra-articular pathology, that is aggravated by activities that load a 
flexed knee joint (K. Crossley, Bennell, Green, & McConnell, 2001; Nunes, Stapait, Kirsten, 
de Noronha, & Santos, 2013), and inclusion criteria for AKP patients in the literature being 
used are most commonly based on this definition as well as on the exclusion of other pathol-
ogies. As these criteria are often vague and heterogenous, the recent systematic review of 
(Leibbrandt & Louw, 2017) proposed an evidence-based checklist for researchers based on 
subjective and objective findings (Figure 1). This checklist will be adopted for this study at 
hand to serve as inclusion/exclusion criteria for participants. Further, Table 1 lists additional 
criteria (as well as their justification), which are specific to the underlying research question of 
this study.  
INCLUSION/EXCLUSION  
CRITERIA 
JUSTIFICATION 
 
Checklist for diagnosis of ante-
rior knee pain (Appendix 1) 
Evidence-based clinical checklist proposed by (Leibbrandt & 
Louw, 2017) for the diagnosis of patients with anterior knee pain 
(AKP).  
 
 
Additional Inclusion Criteria 
 
Age: 18-60 
 
Signs for hip impairment: 
• 
Manually weak tested hip 
abductors/external rota-
tors in comparison to the 
other, unaffected side (at 
least 1 point less on 
Impaired hip function will be evaluated by an experienced physi-
otherapist, who will examine the quality of hip kinematics during 
single leg squat (via visual observation), passive hip range of mo-
tion (via digital goniometer) and eccentric strength of hip abduc-
tors/external rotators (via manual muscle testing). These assess-
ment methods may not meet the highest scientific standards 

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manual muscle rating 
scale 0-10) 
 
• 
Reduced passive hip joint 
mobility in comparison to 
the other, unaffected 
side (at least 10 degrees 
of limitation in at least 
one direction of move-
ment) 
 
• 
Impaired hip kinematics 
during single leg squat. 
 
regarding validity and reliability. However, as they do not serve 
as outcome measures (but only as inclusion criteria), they more 
than suffice, since it is primarily a question of external validity 
and the binary assessment of “is or is there not a hip impairment 
present?”. Further, the minimal detectable change for assess-
ment of hip motions (measured with a goniometer by the same 
person) lies between 4 and 11 degrees (Reese, Bandy 2016). 
Therefore, a side difference of more than 10 degrees should in 
fact be a true restriction (since recent works assessing the relia-
bility of the digital goniometer “Easy Angle” showed even better 
results than using a conventional goniometer (Risberg, 2018)). 
Regarding manual muscle tests, a numerical scale does not allow 
for the fine objective gradations that can be done when measur-
ing units of force. However, the rough classification to discrimi-
nate between strong and weak has shown to be a valid clinical 
tool (Conable & Rosner, 2011; Cuthbert & Goodheart, 2007).  
Prescription for Physiotherapy 
(with the diagnosis AKP) 
Austrian law says, that Physiotherapists are only allowed to treat 
patients if a doctor prescripted physiotherapy in advance.  
Additional Exclusion Criteria 
 
Signs for other possible reasons 
for gluteal inhibition/decondi-
tioning: 
• 
spinal disorders associ-
ated with low back pain, 
lumbar referred pain or 
nerve root irritation 
 
• 
Severe and or recurring 
ankle sprains in recent 
history (significant 
enough, that it required a 
period of immobilization) 
The rationale behind this research is, that the muscle activation 
capacity of AKP patients with weak abductor/external rotator 
muscles may profit from passive hip mobilisation, especially 
when impaired hip function is present and other causes for glu-
teal inhibition/deconditioning are ruled out/less likely. Since the 
diagnosis of AKP is mainly an exclusion of other pathologies, the 
checklist (Appendix 1) stated above already excludes many other 
possible causes for gluteal inhibition. In addition to this list, pa-
tients with severe lumbar as well as ankle problems will be ex-
cluded, as both has been linked to significant impaired gluteal 
function (Bullock-Saxton, 1994; Cooper et al., 2016; Friel, 
McLean, Myers, & Caceres, 2006)  
Pregnancy 
Precautionary measure 
other relevant conditions such as neurologic/rheumatologic/psychiatric diseases, osteoporosis and 
malign disorders. 
Table 1: Inclusion and exclusion criteria (and their justification) of the proposed study at hand 

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Recruitment of subjects will occur in cooperation with doctors (primary care orthopaedics and 
general practitioners) and physiotherapists licensed in Vienna and surrounding area, who are 
specialized in treating musculoskeletal pathologies. Appendix 2 shows a list of names and 
working addresses of all doctors and physiotherapists, who have agreed to support this re-
search. Prior to data collection, I will meet each in person, brief them regarding the inclu-
sion/exclusion criteria as well as procedure of the study and hand over a participant infor-
mation sheet (see attached document: “Patienteninformation”) for them to distribute to possi-
ble participants (and a list with the inclusion/exclusion criteria as a reminder for themselves). 
After a first screening of subjects by telephone (age, pain during which activities, history of 
any relevant trauma/medical condition) I will invite them to my clinic (a group practice with the 
address: Gablenzgasse 11, 1150 Vienna – Austria) for a further evaluation to determine inclu-
sion and exclusion criteria. Participants will be warned about the low risk of soreness to the 

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hip and surrounding muscles, have the opportunity to ask questions about the study, and will 
be informed of their rights to withdraw from the study at any time.  If they meet the inclusion 
criteria and agree to participate in the study they will be asked to sign a consent form (see 
attached document: “Patienteninformation”). 
 
Materials: 
The following equipment will be used during the study: 
• 
A digital goniometer (“Easy Angle”) to determine hip range of motion of both sides.  
• 
For torque measurements, a Hand-Held Dynamometer (HHD) will be used (“Micro-
FET2”). Reasons for using an HHD, instead of the gold standard isokinetic dynamom-
eter, are of practical and financial nature, but also in favor of external validity: Using a 
HHD corresponds much more to manual muscle strength testing commonly used by 
therapists and doctors in daily practice. Further, this instrument has been widely used 
and many studies have shown its excellent intra- and inter-rater reliability for measure-
ment of hip strength (Brindle, Ebaugh, & Milner, 2017; S. Kim & Lee, 2015). 
 
Outcome measures 
 
 
 
 
 
 
Figure 2: CLAM-method for measurement of 
hip abductors/external rotators with HHD 

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The main outcome measure will be muscle strength data obtained from torque measurements 
of the hip abductor/external rotator muscles of participants before and after intervention (via 
manual muscle testing). For measurements the end-position of the popular, non-weight bear-
ing gluteus medius exercise, called the “CLAM”-Exercise will be used (Figure 2). Almeida, das 
Neves Rodrigues et al. (2017) showed that this method of measurement had excellent relia-
bility indices (ICC intra-rater=0.991 [CI 95%, 0.978-0.997] between first and second evaluation 
in patients with AKP) as well as good validity (compared to isolated tests for abduction, exter-
nal rotation and extension with a Pearson’s correlation coefficient equal to 0.65 (P<0.01)) and 
the ability to detect strength deficits between affected and unaffected limb in patients with AKP. 
Aramaki, Katoh et al. (2016) also examined this method to measure hip abduction/external 
rotation torque and found similar good values for their reliability and validity analysis. Hence, 
it is appropriate to use the CLAM-method to measure hip abductor/external rotator strength 
within this research. Table 2 features the reasons that speak in favour of this method instead 
of the commonly used strategies of measuring hip abductor strength (often in sidelying), hip 
external rotator strength (often in sitting) and hip extensor strength (often in prone) separately 
(S. Kim & Lee, 2015; Lu et al., 2011).  
 
REASONS  
JUSTIFICATION 
Favourable gluteal-to-TFL 
activation ratio 
As described in the introduction, AKP patients show significant weak-
ness in hip abduction, external rotation and extension (which complies 
with the function of gluteus medius and superior part of gluteus maxi-
mus (Neumann, 2010)). The tensor fascia latae (TFL) on the other hand, 
in addition to being an abductor, is an internal rotator of the hip and 
can also exert a lateral force on the patella via connections to the ili-
otibial band (Merican, Amis 2009). Both, excessive hip internal rotation 
and lateral patellar displacement, have been linked to AKP (Powers 
2010). Therefore, a measurement method to detect gluteal weakness 
in patients with AKP should promote gluteal activation as well as mini-
mize TFL recruitment. Selkowitz, Beneck and Powers (2013) examined 
eleven different exercises on the basis of electromyographic signals us-
ing fine-wire electrodes and found, that the CLAM exercise had by far 

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the most favourable gluteal-to-TFL activation ratio. In contrast, side-
lying hip abduction showed no such favourable activation ratio. 
Better Conrollability of 
possible compensatory 
movements 
The commonly used (Widler et al., 2009) manual muscle strength test 
of hip abductors in side-lying (with the tested leg up in hip abduction, 
extension and slight external rotation (knee joint in extension)) is hard 
to reach, especially for patients with expected weaknesses. Typical 
compensations would be hip flexion and/or dorsal rotation of the pel-
vis, both movements facilitating the tensor fascia latae muscle (Kendall 
et al., 2005). A test position which is hard to reach for subjects and 
hard to control for examiners does not seem appropriate to get mean-
ingful results. With the CLAM-method on the other side, the pelvic of 
the patient can be far better stabilized/controlled. 
Functionality and Practica-
bility 
This method was developed to allow a three-dimensional evaluation of 
gluteal muscle strength, which makes it more functional when com-
pared to the uniplanar assessment of the hip muscles (Almeida, das 
Neves Rodrigues, Helena Larissa, De Freitas, & de Paula Lima, Pedro 
Olavo, 2017). Further, in clinical practice, separately testing requires 
repetitive training, testing, rest periods, and positioning adjustments 
for the tests (Piva, Teixeira et al. 2011), which is tiring for the patient 
and time consuming for the therapist, whereas the CLAM-method is a 
quick and easy alternative. 
Table 2: Reasons for using the CLAM-methode for measuring hip abductor/external rotator strength 
 
Different from the previously mentioned studies measuring with the CLAM-method, this study 
will use a “break test” instead of a “make test” and therefore measure eccentric rather than 
concentric muscle strength. Both methods in general show similar reliability (Conable & Ros-
ner, 2011), but eccentric hip torque especially has been associated with functional capacity 
and pain levels in patients with AKP (de Marche Baldon et al., 2012; Nakagawa, de Marche 
Baldon, Muniz, & Serrão, 2011), and as the break test measures a complex proprioceptive 
response to changing pressure (rather than solely an isometric peak force), it seems to be a 
more valid method to measure functional impairments. Of course, even more meaningful 
would be strategies, that measure timing, activity level and capability to control movements of 
agonists and antagonists during different functional tasks, however, such methods would go 
beyond the scope of this dissertation.  
 
 

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Procedure: 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 2:      Stage of study 
  
Short description of stage   
             Collector of data 
 
Figure 2 illustrates the procedure of the proposed study. Researcher 1 (a physiotherapist 
trained in manual therapy, with seven years of clinical experience) will perform examination 
procedures and data collection (Appendix 5). If subjects agree to participate and meet inclu-
sion criteria, they will be randomly assigned to either Group 1 or Group 2. Group 1 will re-
ceive the real intervention during the first period of measurement and a control/sham inter-
vention one week later. Group 2 vice versa. Hence, each participant will serve as his/her 
own control group. As a simple randomization method is not recommended for a sample size 
of less than 100 (J. Kim & Shin, 2014), randomization sequence will be created using an 
online application called “Sealed Envelope” (Sealed Envelope Ltd, 2017) with random block 
 P E R I O D   1 
P E R I O D    2 
Examination 
stage 
Group Alloca-
tion stage 
Pretest 1 
Intervention 
stage 1 
Posttest 1 
Evaluation of inclusion and exclusion cri-
teria, data collection  
Randomized allocation of participants to 
either Group 1 or Group 2  
Researcher 1 
(Georg Pflügler) 
Researcher 1 
(Georg Pflügler) 
Group 1: real 
intervention 
Group 2: sham 
intervention 
Researcher 2 
(Johanna Kasper) 
manual muscle strength test 
(CLAM-method) 
manual muscle strength test 
(CLAM-method) 
Pretest 2 
Intervention 
stage 2 
Posttest 2 
manual muscle strength test 
(CLAM-method) 
Group 1: sham 
intervention 
Group 2: real 
intervention 
manual muscle strength test 
(CLAM-method) 
Researcher 1 
(Georg Pflügler) 
Researcher 1 
(Georg Pflügler) 
Researcher 1 
(Georg Pflügler) 
Researcher 1 
(Georg Pflügler) 
Researcher 2 
(Johanna Kasper) 
One week washout phase 
First Contact: 
Phone Call 
Preliminary evaluation of inclusion and 
exclusion criteria,  
Researcher 1 
(Georg Pflügler) 

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sizes of 4 and 6. This study will be double-blinded in the sense that both, subjects and the 
assessor of hip strength will be blinded to group assignment, whereas the therapist (Re-
searcher 2), who carries out the interventions, will be the group allocator and not be blinded 
to group assignment.  
Torque measurement (Pre-Test) will be obtained by Researcher 1 (a physiotherapist trained 
in the use of a HHD; seven years of clinical experience) using the Clam-method (Figure 1). 
See Appendix 5 for a detailed protocol. To maintain blinding, the subsequent interventions will 
be performed by Researcher 2, who will make sure that Researcher 1 has left the room. Ac-
cording to the respective group assignment, participants will either receive a hip joint mobili-
zation or a sham intervention (see Table 3 for a detailed description). All subjects will be re-
tested (Post-Test) from Researcher 1 by using the same method as pre-intervention to estab-
lish post-intervention muscle strength immediately afterwards. In addition, Researcher 1 will 
use a scale to determine the subjective felt change in strength of participants and will assess 
the passive range of movement of the respective motions, which were restricted before the 
intervention, by using a digital goniometer.  
One week later, the participants will be put through the same procedure again. Only this time, 
Group 2 will receive the real intervention, whereas Group 1 will get the placebo intervention.  
 
INTERVENTION 
JUSTIFICATION 
Intervention 
 
Passive hip joint mobiliza-
tion:  
passive accessory movement 
on femur in anterior/poste-
rior direction, grade III for 
four minutes and passive 
physiological movement of 
the most restricted hip joint 
movement, grade III for one 
minute (without pain).  
The selection of this method of mobilization is not based on a theory 
of peripherally acting and specific biomechanical mechanisms. As Bi-
alosky, Beneciuk et al. (2018) argue in their proposed model on 
mechanisms of manual therapy (MT), the literature does not support 
such a traditional mechanical theory. Their recent model rather sug-
gests that a mechanical stimulus initiates a number of potential neu-
rophysiological effects which produce the clinical outcomes associ-
ated with MT; the choice of technique does not seem to matter as 
much as identifying an individual likely to respond. That is why the in-
clusion criteria of this study are signs of hip impairment as well as no 
signs of other possible causes for gluteal inhibition/deconditioning 

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(therefore individuals seem more likely to profit from hip joint mobili-
zation).  
The rationale behind the possible effect of MT on muscle strength is 
the stimulating of sensory receptors in and around the joint in order 
to modulate altered joint afferent discharge and thereby disinhibit-
ing/facilitating the musculature surrounding this joint. As the direc-
tion of the mobilisation may not be as relevant, other factors such as 
intensity, duration and location, on the other hand I believe is.  
But why using the described method then (ap mobilisation, grade III)? 
– It is a relaxing position for the patient (supine with a knee roll), 
where the therapist may easily accomplish a mechanical stimulus 
specifically directed to the hip joint (which shows impairments), com-
fortably and without pain. Further, the subsequent passive physiolog-
ical mobilisation addresses an individual impairment of the patient 
too. And lastly, because I have had good results with this method in 
my personal clinical experience.  
Control Intervention 
 
Sham hip joint mobilization: 
grade I, very small amplitude 
without encountering any 
tissue resistance for five 
minutes. Hence, effectively 
just a laying on of hands. 
In studies it is ethically acceptable to use placebo/sham interventions 
where no current proven intervention exists and when their use does 
not expose research participants to excessive risk of any serious or ir-
reversible harm (Fregni et al., 2010) and both is the case for the pro-
posed study. 
As it is recommended that there should be as little variability in inter-
ventions as possible in between both the real and the placebo groups 
(Fregni et al., 2010), the control group will receive a sham hip joint 
mobilisation with the same duration, same setting, same therapist 
and similar verbal education of underlying effect mechanisms, but 
different intensity/mechanical stimulus. 
Reason for using a Placebo Intervention:  
Although any benefit seen from MT likely arises from a complex inter-
play between neurophysiological effects, placebo, patient expecta-
tion, and therapeutic alliance (Bialosky, Beneciuk et al. 2018), this 
study will try to highlight, that these possible confounding variables 
alone are not as effective (in this case regarding muscle strength) as 
combined with an appropriate mechanical stimulus.  
Table 3: Description and justification of the used Interventions of the proposed study 
 
Sample size Calculation 
To calculate the proper sample size required for the study, a power calculation was under-
taken, based on the alpha value, statistical power and the estimated effect size and the meas-
urement variance expected to occur if the measurement procedure would be repeated a large 
number of times in the same patient under identical conditions (Wellek & Blettner, 2012). As 
conventionally done, alpha level was set at 0,05 and statistical power at 0,8 (Ellis, 2010). The 

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results of the work of Yerys and coworkers (2002) have been used as reference to estimate 
the effect size for this study: applying a calculation method appropriate for cross-over designs  
(Wellek & Blettner, 2012) their results lead to an expected effect size of 1,34. The expected 
measurement variance is 2,1 (kgf) and has been determined with the aid of a small pilot study.  
Therefore, on the bases of these values and with the aid of an unpaired t-test (Wellek & 
Blettner, 2012), the appropriate sample size for this study has been calculated to be 16 (8 per 
group). Allowing for drop-outs and to make sure that this study will be adequately powered, 
the total sample size will 20. 
 
Pilot study 
A pilot study has been conducted prior to the carrying out of the main study, with the aim to 
establish the time required to examine and measure each participant, to familiarise the re-
searchers with the experimental procedures and to determine the expected measurement var-
iance for the sample size calculations. Four healthy and voluntary participants have been re-
cruited. All has been conducted under the same test conditions as those highlighted in the 
proposed main study. The data recorded in the course of the pilot study will not be included in 
the final analysis.  
 
Data Collection 
See Appendix 6 for a list of all variables that are going to be collected in the course of this 
study. This list highlights their level of measurement, domain or coding, during which stage of 
the measurements they will be collected, who will collect them and why they are going to be 
collected.  
During the evaluation of inclusion/exclusion criteria, the data of the physical examination pro-
cedure and some personal data (gender, age, height, weight) will be required by all 

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participants. Any data obtained from participants who do not meet inclusion criteria will be 
deleted immediately. Any data obtained from participants who do meet the criteria will be rec-
orded by Researcher 1 for all participants. No participant will be identifiable from the data 
collected. Researcher 2 will be the group allocator and only person, to know the group assign-
ment.  
Each participant will be given a unique study ID. Patient details and study ID will be kept purely 
for administrative reasons and will be contained in a password protected file which only mem-
bers of the research team will have access to. Data files will use only study ID numbers to 
ensure that participants cannot be recognized.  Following the measurements, all data will be 
kept confidential in a research file, which will be stored in a locked cupboard. See Appendix 9 
for the actual Data Sheets being used in the course of this study. All electronic data will be 
stored on a password secured lap-top.  
 
 
Statistical Analysis: 
The data will be analyzed using the Stata/IC15.1 software. At first, raw data will be analyzed 
using descriptive statistcs (mean and standard deviation of anthropometric and clinical char-
acteristics and the outcome variables) and screened for any evident anomalies, which, if pre-
sent, will be explored in the discussion following the investigation. Prior to further inferential 
statistical analysis, the Post-test differences of both groups (the differences between treatment 
effects) of the dependent variable (torque measurements) will be checked for normal distribu-
tion using the Shapiro-Wilk test, which is appropriate for small sample sizes (Schäfer & 
Schöttker-Königer, 2015) and a box and whisker plot will be prepared to eyeball the distribution 
of data. The values of the torque measurements are scaled metrically (muscle strength data 
will be normalized by the body mass of each participant: strength[kgf]/bmi[kg]). 

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Researchers analyzing the data of crossover trials often proceed as though they were per-
forming a simple pre/post comparison by using a paired t-test or any other procedure for paired 
samples, which presents a methodologically flawed analysis (Wellek & Blettner, 2012). This 
error will not happen within this research. Two things have to be analyzed within the crossover 
design: Firstly, the assumption of negligible carryover effects between the two periods (with 
the help of an unpaired t-test with the sums of the Post-test-values). If this test does not yield 
a significant result, then the assessment of the difference between treatment effects (interven-
tion versus control) is indicated: Again with the help of an unpaired t-test, but this time on the 
bases of the within-subject differences of the Post-test-values. 
If the data is not normally distributed, non-parametric methods such as the Wilcoxon test or 
the Mann Whitney test will be applied. P-values of less than 0.05 will be considered significant 
(Schäfer & Schöttker-Königer, 2015). 
 
Ethical Considerations 
The primary consideration of any research involving human subjects has to be the safety, 
health, dignity, right to self-determination, privacy and confidentiality of personal information 
of the participants, as stated in the Declaration of Helsinki (World Medical Association, 2013). 
Certainly, these considerations will be carefully implemented in the proposed study.  
Prior to participating each participant will receive an information sheet and a consent form. 
Time will be allocated for each participant to read the information sheet, sign the consent form 
and ask further questions. Participants will be free to withdraw from the study at any time 
without giving reasons (Guraya, London, & Guraya, 2014). 
In studies it is ethically acceptable to use placebo/sham interventions where no current proven 
intervention exists and when their use does not expose research participants to excessive risk 
of any serious or irreversible harm (Fregni et al., 2010). As both is the case in this proposed 

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study, and because of the fact that participants will only have to spend two single additional 
session of approximately 30 minutes (therefore there will be no delay in ordinary treatment for 
anyone), it is ethical to use a placebo group in this case.  
A risk assessment form is shown in Appendix 8.  Prior to the submission to the Ethic Commit-
tee of the Medical University of Vienna, the proposed study has been submitted to the Shef-
field Hallam University Ethics Committee and has gain approval. However, no testing will com-
mence until ethical approval from Vienna has been granted.  
 
Reporting 
Upon completion of this study, a report will be prepared for potential publication. The aim is to 
publish in a recognised, peer reviewed Physiotherapy specific journal. If desired, findings will 
also be disseminated to all participants that were involved in the study.  
 
Funding 
The two researchers involved will work for this project without payment. There will be no costs 
expected to complete this study, excluding the already purchased hand held dynamometer, 
which is now private propriety of the first researcher. Other equipment and environment 
needed for the carrying out of the study will be provided by the group practice, the two involved 
researchers are part of. This clinic conforms to the Austrian guidelines that are required for 
working with patients in a physiotherapeutic setting. 
There will be no conflict of interest.  
 

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References 
References 
Almeida, G. P. L., das Neves Rodrigues, Helena Larissa, De Freitas, B. W., & de Paula 
Lima, Pedro Olavo. (2017). Reliability and validity of the hip stability isometric test 
(HipSIT): A new method to assess hip posterolateral muscle strength. Journal of 
Orthopaedic & Sports Physical Therapy, 47(12), 906-913.  
Bialosky, J. E., Beneciuk, J. M., Bishop, M. D., Coronado, R. A., Penza, C. W., Simon, C. B., 
& George, S. Z. (2018). Unraveling the mechanisms of manual therapy: Modeling an 
approach. Journal of Orthopaedic & Sports Physical Therapy, 48(1), 8-18.  
Bialosky, J. E., Bishop, M. D., Price, D. D., Robinson, M. E., & George, S. Z. (2009). The 
mechanisms of manual therapy in the treatment of musculoskeletal pain: A 
comprehensive model. Manual Therapy, 14(5), 531-538.  
Boling, M. C., Padua, D. A., Marshall, S. W., Guskiewicz, K., Pyne, S., & Beutler, A. (2009). A 
prospective investigation of biomechanical risk factors for patellofemoral pain syndrome: 
The joint undertaking to monitor and prevent ACL injury (JUMP-ACL) cohort. The 
American Journal of Sports Medicine, 37(11), 2108-2116.  
Brindle, R. A., Ebaugh, D. D., & Milner, C. E. (2017). Intra-tester reliability and construct 
validity of a hip abductor eccentric strength test. Journal of Sport Rehabilitation, , 1-13.  
Bullock-Saxton, J. E. (1994). Local sensation changes and altered hip muscle function 
following severe ankle sprain. Physical Therapy, 74(1), 17-28.  
Conable, K. M., & Rosner, A. L. (2011). A narrative review of manual muscle testing and 
implications for muscle testing research. Journal of Chiropractic Medicine, 10(3), 157-
165.  
Cooper, N. A., Scavo, K. M., Strickland, K. J., Tipayamongkol, N., Nicholson, J. D., Bewyer, 
D. C., & Sluka, K. A. (2016). Prevalence of gluteus medius weakness in people with 
chronic low back pain compared to healthy controls. European Spine Journal, 25(4), 
1258-1265.  
Crossley, K. M. (2014). No title. Is Patellofemoral Osteoarthritis a Common Sequela of 
Patellofemoral Pain?,  
Crossley, K., Bennell, K., Green, S., & McConnell, J. (2001). A systematic review of physical 
interventions for patellofemoral pain syndrome. Clinical Journal of Sport Medicine, 
11(2), 103-110.  
Cuthbert, S. C., & Goodheart, G. J. (2007). On the reliability and validity of manual muscle 

21 
 
 Study Proposal 
 
Version 1.5 vom 03.12.18 
 
testing: A literature review. Chiropractic & Osteopathy, 15(1), 4.  
de Marche Baldon, R., Lobato, D. F. M., Carvalho, L. P., Wun, P. Y. L., Presotti, C. V., & 
Serrão, F. V. (2012). Relationships between eccentric hip isokinetic torque and 
functional performance. Journal of Sport Rehabilitation, 21(1), 26-33.  
Ellis, P. D. (2010). The essential guide to effect sizes: Statistical power, meta-analysis, and 
the interpretation of research results Cambridge University Press. 
Foss, K. D. B., Hornsby, M., Edwards, N. M., Myer, G. D., & Hewett, T. E. (2012). Is body 
composition associated with an increased risk of developing anterior knee pain in 
adolescent female athletes? The Physician and Sportsmedicine, 40(1), 13-19.  
Freeman, S., Mascia, A., & McGill, S. (2013). Arthrogenic neuromusculature inhibition: A 
foundational investigation of existence in the hip joint. Clinical Biomechanics (Bristol, 
Avon), 28(2), 171-177. doi:10.1016/j.clinbiomech.2012.11.014 
Fregni, F., Imamura, M., Chien, H. F., Lew, H. L., Boggio, P., Kaptchuk, T. J., . . . Furlan, A. 
(2010). Challenges and recommendations for placebo controls in randomized trials in 
physical and rehabilitation medicine: A report of the international placebo symposium 
working group. American Journal of Physical Medicine & Rehabilitation/Association of 
Academic Physiatrists, 89(2), 160.  
Friel, K., McLean, N., Myers, C., & Caceres, M. (2006). Ipsilateral hip abductor weakness 
after inversion ankle sprain. Journal of Athletic Training, 41(1), 74.  
Gabler, C. M., Lepley, A. S., Uhl, T. L., & Mattacola, C. G. (2016). Comparison of 
transcutaneous electrical nerve stimulation and cryotherapy for increasing quadriceps 
activation in patients with knee pathologies. Journal of Sport Rehabilitation, 25(3), 294-
300.  
Guraya, S. Y., London, N., & Guraya, S. S. (2014). Ethics in medical research. Journal of 
Microscopy and Ultrastructure, 2(3), 121-126.  
Hamstra-Wright, K. L., Earl-Boehm, J., Bolgla, L., Emery, C., & Ferber, R. (2017). Individuals 
with patellofemoral pain have less hip flexibility than controls regardless of treatment 
outcome. Clinical Journal of Sport Medicine, 27(2), 97-103.  
Harkey, M. S., Gribble, P. A., & Pietrosimone, B. G. (2014). Disinhibitory interventions and 
voluntary quadriceps activation: A systematic review. Journal of Athletic Training, 49(3), 
411-421.  
Kim, J., & Shin, W. (2014). How to do random allocation (randomization). Clinics in 
Orthopedic Surgery, 6(1), 103-109.  
Kim, S., & Lee, Y. (2015). The intra-and inter-rater reliabilities of lower extremity muscle 

22 
 
 Study Proposal 
 
Version 1.5 vom 03.12.18 
 
strength assessment of healthy adults using a hand held dynamometer. Journal of 
Physical Therapy Science, 27(6), 1799-1801.  
Leibbrandt, D. C., & Louw, Q. (2017). The development of an evidence-based clinical 
checklist for the diagnosis of anterior knee pain. South African Journal of Physiotherapy, 
73(1), 1-10.  
Lu, Y., Lin, J., Hsiao, S., Liu, M., Chen, S., & Lue, Y. (2011). The relative and absolute 
reliability of leg muscle strength testing by a handheld dynamometer. The Journal of 
Strength & Conditioning Research, 25(4), 1065-1071.  
Makofsky, H., Panicker, S., Abbruzzese, J., Aridas, C., Camp, M., Drakes, J., . . . Sileo, R. 
(2007). Immediate effect of grade IV inferior hip joint mobilization on hip abductor 
torque: A pilot study. Journal of Manual & Manipulative Therapy, 15(2), 103-110.  
Nakagawa, T. H., de Marche Baldon, R., Muniz, T. B., & Serrão, F. V. (2011). Relationship 
among eccentric hip and knee torques, symptom severity and functional capacity in 
females with patellofemoral pain syndrome. Physical Therapy in Sport, 12(3), 133-139.  
Neumann, D. A. (2010). Kinesiology of the hip: A focus on muscular actions. Journal of 
Orthopaedic & Sports Physical Therapy, 40(2), 82-94.  
Niemuth, P. E., Johnson, R. J., Myers, M. J., & Thieman, T. J. (2005). Hip muscle weakness 
and overuse injuries in recreational runners. Clinical Journal of Sport Medicine, 15(1), 
14-21.  
Noehren, B., Hamill, J., & Davis, I. (2013). Prospective evidence for a hip etiology in 
patellofemoral pain. Medicine and Science in Sports and Exercise, 45(6), 1120-1124.  
Nunes, G. S., Stapait, E. L., Kirsten, M. H., de Noronha, M., & Santos, G. M. (2013). Clinical 
test for diagnosis of patellofemoral pain syndrome: Systematic review with meta-
analysis. Physical Therapy in Sport, 14(1), 54-59.  
Pietrosimone, B., Blackburn, J. T., Harkey, M. S., Luc, B. A., Pamukoff, D. N., & Hart, J. M. 
(2015). Clinical strategies for addressing muscle weakness following knee injury. Clinics 
in Sports Medicine, 34(2), 285-300.  
Powers, C. M., Bolgla, L. A., Callaghan, M. J., Collins, N., & Sheehan, F. T. (2012). No title. 
Patellofemoral Pain: Proximal, Distal, and Local Factors—2nd International Research 
Retreat, August 31–September 2, 2011, Ghent, Belgium,  
Prins, M. R., & Van Der Wurff, P. (2009). Females with patellofemoral pain syndrome have 
weak hip muscles: A systematic review. Australian Journal of Physiotherapy, 55(1), 9-
15.  
Rankin, G., Rushton, A., Olver, P., & Moore, A. (2012). Chartered society of physiotherapy's 

23 
 
 Study Proposal 
 
Version 1.5 vom 03.12.18 
 
identification of national research priorities for physiotherapy using a modified delphi 
technique. Physiotherapy, 98(3), 260-272.  
Rathleff, M. S., Rathleff, C. R., Crossley, K. M., & Barton, C. J. (2014). Is hip strength a risk 
factor for patellofemoral pain? A systematic review and meta-analysis. Br J Sports Med, 
, 093305.  
Reese, N. B., & Bandy, W. D. (2016). Joint range of motion and muscle length testing-E-
book Elsevier Health Sciences. 
Rice, D. A., & McNair, P. J. (2010). Quadriceps arthrogenic muscle inhibition: Neural 
mechanisms and treatment perspectives. Seminars in Arthritis and Rheumatism, 40(3), 
250-266. doi:10.1016/j.semarthrit.2009.10.001 
Risberg, P. (2018). Samband mellan höftrörlighet och bålrotation hos professionella 
golfspelare: Proas majors inverkan på bålrotationen. 
Sanchis-Alfonso, V., McConnell, J., Monllau, J. C., & Fulkerson, J. P. (2016). Diagnosis and 
treatment of anterior knee pain. Journal of ISAKOS: Joint Disorders & Orthopaedic 
Sports Medicine, 1(3), 161-173.  
Schäfer, A., & Schöttker-Königer, T. (2015). Statistik und quantitative methoden für 
gesundheitsfachberufe Springer. 
Sealed Envelope Ltd. (2017). &nbsp;create a blocked randomisation list. Retrieved from 
https://www.sealedenvelope.com/simple-randomiser/v1/lists 
Tan, S. S., Van Linschoten, R. L., Van Middelkoop, M., Koes, B. W., Bierma‐Zeinstra, S. M., 
& Koopmanschap, M. A. (2010). Cost‐utility of exercise therapy in adolescents and 
young adults suffering from the patellofemoral pain syndrome. Scandinavian Journal of 
Medicine & Science in Sports, 20(4), 568-579.  
Wellek, S., & Blettner, M. (2012). On the proper use of the crossover design in clinical trials: 
Part 18 of a series on evaluation of scientific publications. Deutsches Ärzteblatt 
International, 109(15), 276.  
Widler, K. S., Glatthorn, J. F., Bizzini, M., Impellizzeri, F. M., Munzinger, U., Leunig, M., & 
Maffiuletti, N. A. (2009). Assessment of hip abductor muscle strength. A validity and 
reliability study. Jbjs, 91(11), 2666-2672.  
World Medical Association. (2013). World medical association declaration of helsinki: Ethical 
principles for medical research involving human subjects. Jama, 310(20), 2191.  
Yerys, S., Makofsky, H., Byrd, C., Pennachio, J., & Cinkay, J. (2002). Effect of mobilization of 
the anterior hip capsule on gluteus maximus strength. Journal of Manual & Manipulative 
Therapy, 10(4), 218-224.  

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Appendix 1 
Preliminary Inclusion/Exclusion Criteria: 
Preliminary Inclusion and Exclusion Criteria 
Inclusion Criteria 
Exclusion Criteria 
peripatellar or retropatellar pain 
History of trauma 
pain aggravated by activities that 
load a flexed knee joint 
Previous lower limb surgery 
weak tested hip abductors/external 
rotators (CLAM-method) 
intra-articular pathology (knee joint) 
 
 
Vorläufige Ein- und Ausschlusskriterien:  
Vorläufige Ein- und Ausschlusskriterien 
Einschlusskriterien 
Ausschlusskriterien 
voderer Knieschmerz 
Vorangegangenes Trauma 
Schmerzverstärkung bei Aktivitäten, 
welche das Kniegelenk in einer ge-
beugten Stellung belasten  
Vorangegangene Operation an der unteren 
Extremität 
schwach getestete Hüftab-
duktoren/Außenrotatoren (CLAM-
Methode) 
Intra-artikuläre Pathologie des Kniegelenks 
 
 
 
 
 

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Appendix 2 
 
 
The following list shows the names and working addresses of all doctors and physiothera-
pists, who have agreed to support this research: 
 
NAME 
PROFESSION 
ADDRESS  
Manfred Neumaier 
Orthopaedist 
Wienerstr. 2/2/3, 2340 Mödling  
Ursula Leitner 
General practioner 
Hartlgasse 15, 2486 Pottendorf 
Herbert Prohaska  
Orthopaedist 
Kreuzgasse 37/2, 1180 Wien 
Johanna Kasper 
Physiotherapist 
Kreuzgasse 37/2, 1180 Wien 
Gablenzgasse 11, 1150 Wien 
Evelyne Tratter 
Physiotherapist 
 
 
 
 
 
 
 
Gablenzgasse 11, 1150 Wien  
Jakob Mauracher 
Physiotherapist 
Antonia Navratil-Schmidt 
Physiotherapist 
Friederike Kreuzer-Rath 
Physiotherapist 
Stephanie Huber 
Physiotherapist 
Julian Gullner 
Physiotherapist 
Andrea Höller 
Physiotherapist 
Katja Friedmann 
Physiotherapist 
Elmari du Preez 
Physiotherapist 
Sophia Billet 
Physiotherapist 
Heinz Aigner 
Physiotherapist 
Laszlo Roth 
Physiotherapist 
 
 
 
 
 
Kreuzgasse 37/2, 1180 Wien 
 
Sabine Weissmann 
Physiotherapist 
Seraph Buttinger 
Physiotherapist 
Barbara Pavlis 
Physiotherapist 
Jakob Eschwé 
Physiotherapist 
Sandra Brunner 
Physiotherapist 
Katrin Köhler  
Physiotherapist 
Florian Raderbauer 
Physiotherapist 
Patrick Gomez 
Physiotherapist 
Huttengasse 37/15, 1160 Wien 
 
 
 
 

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Appendix 5 
 
 
Protocol of outcome measurement: 
 
 
 
 
 
 
Figure 1: CLAM-method for measurement of 
hip abductors/external rotators with HHD 
 
Prior to measurement, a mark will be placed five centimeters proximal to the middle of the 
knee joint line (along the body’s longitudinal axis), to provide a consistent landmark for dyna-
mometer placement. The CLAM-method will be performed with the participant in side-lying, 
with both legs positioned at 45° of hip flexion and 90° of knee flexion, with the limb to be 
tested superior (Figure 1). The participant will be instructed to lift the knee of the superior leg 
as far as possible while keeping the heels in contact, without allowing any compensatory 
movements. Following a warm-up consisting of one submaximal and one maximal practice 
trial, participants will perform three measurements with isometric contraction at their maximum 
exertion (with a 30 seconds rest between each trial). The instructions for the break test will be 
"Push as hard as you can; now don't let me move your leg." Consistent verbal encouragement 
will be provided during the slow increase of the applied force, until the resistance of the par-
ticipant gets broken. Mean values will be calculated for each participant. If compensation 
movements are present, values will be discarded and a new measurement will be done after 
30 seconds. No feedback (regarding their torque measure) will be provided to the subjects 
during the testing period. 

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Appendix 6 
 
Variable list of the proposed study: 
Nr 
Abbrevation 
Variable 
Level of 
Measure-
ment 
Domain/Coding 
Stage of measurement 
and 
Collector of data  
Reason for measure-
ment 
1 
id 
Identification number of 
participant 
nominal 
0-20 
Group Allocation stage. 
Researcher 2 
Statistical analysis 
2 
group 
Group affiliation of partici-
pant 
nominal 
1 = first session intervention, 
second session placebo 
2 = vice versa 
Methodology of study 
3 
female 
Gender of participant 
nominal 
0 = male 
1 = female 
 
 
 
 
 
 
 
 
 
Examination stage. 
Researcher 1 
Description of sample 
4 
age 
Age of participant 
metric 
Integral Numbers 
Description of sample 
 
right 
affected side 
nominal 
0 = left 
1 = right 
 
5 
weight 
Weight of participant 
metric 
Integral Numbers (in kg) 
Normalization of Out-
come measure 
6 
height 
Height of participant 
metric 
Integral Numbers (in cm) 
Normalization of Out-
come measure 
7 
checklist 
checklist for diagnosis of 
AKP 
nominal 
0 = fulfils checklist 
1 = does not fulfil checklist 
assessment of inclu-
sion/exclusion criteria 
8 
slsq 
Quality of single leg squat 
nominal 
0 = normal 
1 = impaired 
assessment of inclusion 
criteria 
9 
strength 
Strength of hip abd/er 
nominal 
0 = normal 
1 = weak 
assessment of inclusion 
criteria 
10 
flex_l 
ROM hip flexion, L 
metric 
Integral Numbers (in degree) 
 
 
 
 
 
11 
flex_r  
ROM hip flexion, R 
metric 
Integral Numbers (in degree) 
12 
er90_l 
ROM hip ER/90, L 
metric 
Integral Numbers (in degree) 
13 
er90_r 
ROM hip ER/90, R 
metric 
Integral Numbers (in degree) 
14 
ir90_l 
ROM hip IR/90, L 
metric 
Integral Numbers (in degree) 

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15 
ir90_r 
ROM hip IR/90, R 
metric 
Integral Numbers (in degree) 
 
 
assessment of inclusion 
criteria 
16 
abd_l 
ROM hip abd, L 
metric 
Integral Numbers (in degree) 
17 
abd_r 
ROM hip abd, R 
metric 
Integral Numbers (in degree) 
18 
add_l 
ROM hip add, L 
metric 
Integral Numbers (in degree) 
19 
add_r 
ROM hip add, R 
metric 
Integral Numbers (in degree) 
20 
ext_l 
ROM hip ext, L 
metric 
Integral Numbers (in degree) 
21 
ext_r 
ROM hip ext, R 
metric 
Integral Numbers (in degree) 
22 
er0_l 
ROM hip ER/0, L 
metric 
Integral Numbers (in degree) 
23 
er0_r 
ROM hip ER/0, R 
metric 
Integral Numbers (in degree) 
 
ir0_l 
ROM hip IR/0, L 
metric 
Integral Numbers (in degree) 
 
 
 
ir0_r 
ROM hip IR/0, R 
metric 
Integral Numbers (in degree) 
 
 
24 
pretest_1_mean 
mean of strength tests of 
hip abd/er of affected 
side (first period) 
metric 
0.4 to 135 (in kilograms force 
with 0.1 increments) 
Pretest 1. 
Researcher 1 
determing torque values 
before intervention 
 
pret-test_1_i 
 
 
 
 
 
pret-test_1_ii 
 
 
 
 
 
pret-test_1_iii 
 
 
 
 
25 
pretest_1_pain 
reportment of pain during 
pretest (first period) 
nominal 
0 = no pain 
1 = pain 
for interpretation of re-
sults (later in the discus-
sion section of this study) 
26 
posttest_1_mean 
strengthtest after inter-
vention (first period) 
metric 
0.4 to 135 (in kilograms force 
with 0.1 increments) 
Posttest 1. 
Researcher 1 
determing torque values 
after intervention 
 
post-test_1_i 
 
 
 
 
 
post-test_1_ii 
 
 
 
 
 
post-test_1_iii 
 
 
 
 
27 
posttest_1_pain 
reportment of pain during 
posttest (first period) 
nominal 
0 = no pain 
1 = pain 
for interpretation of re-
sults 
 
subj_change_1 
 
 
 
 
 
 
p_rom_change_1_* 
 
 
 
 
 
 
p_rom_change_1_* 
 
 
 
 
 
 
p_rom_change_1_* 
 
 
 
 
 

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28 
pretest_2_mean 
strength of hip abd/er 
with hhd of affected side 
(second period) 
metric 
0.4 to 135 (in kilograms force 
with 0.1 increments) 
Pretest 2. 
Researcher 2 
determing torque values 
before intervention 
 
pret-test_2_i 
 
 
 
 
 
pret-test_2_ii 
 
 
 
 
 
pret-test_2_iii 
 
 
 
 
29 
pretest_2_pain 
reportment of pain during 
pretest (second period) 
nominal 
0 = no pain 
1 = pain 
for interpretation of re-
sults 
30 
posttest_2_mean 
strengthtest after inter-
vention (second period) 
metric 
0.4 to 135 (in kilograms force 
with 0.1 increments) 
Posttest 2. 
Researcher 2 
determing torque values 
after intervention 
 
post-test_2_i 
 
 
 
 
 
post-test_2_ii 
 
 
 
 
 
post-test_2_iii 
 
 
 
 
31 
posttest_2_pain 
reportment of pain during 
posttest (second period) 
nominal 
0 = no pain 
1 = pain 
for interpretation of re-
sults 
 
subj_change_2 
 
 
 
 
 
 
p_rom_change_2_* 
 
 
 
 
 
 
p_rom_change_2_* 
 
 
 
 
 
 
p_rom_change_2_* 
 
 
 
 
 
 

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Appendix 7 
 
 
Data Management Plan  
 
 
1. What data will you collect or create? 
see appendix 6 
 
 
2. How will your data be documented and described? 
see appendix 6 
 
 
3. How will you deal with any ethical and copyright issues? 
see “Ethical Considerations” (proposal) 
 
 
4. How will your data be structured, stored, and backed up? 
see “Data Collection” (proposal) 
 
 
5. What are your plans for the long-term preservation of data supporting your research? 
see “Data Collection” (proposal) 
 
 
 
 
6. What are your plans for data sharing after submission of your thesis? 
see “Reporting” (proposal) 
 
 
 
 

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Appendix 8 
 
 
 
 
 
 
MA/MBA/MSc Dissertation Proposal  
FACULTY OF HEALTH AND WELLBEING 
 
PROJECT SAFETY PLAN:  Risk Assessment Form 
 
 
 
 
TITLE: 
 
The immediate effects of passive hip 
joint mobilization on hip abductor/exter-
nal rotator muscle strength in patients 
with anterior knee pain and impaired hip 
function 
 
LOCATION: 
 
Gablenzgasse 11, 1150 Vienna 
 
PEOPLE AF-
FECTED: 
 
Patients with anterior knee pain who meet inclusion criteria and agree to participate 
ASSESSMENT 
CARRIED OUT BY: 
 
Pflügler Georg (Physiotherapist) and Kasper Johanna (Physiotherapist) 
PROJECT SAFETY 
OFFICER: 
 
 
 
SUPERVISOR: 
 
Sionnadh McLean 
SIGNATURE OF 
SUPERVISOR 
 
 
 
DATE: 
 
 
 
 
ACTIVITY 
 
HAZARD ASSOCIATED 
WITH THE ACTIVITY 
 
HAZARD 
RATING 
(High, Me-
dium or 
Low) 
 
CONTROL MEASURES TO BE TAKEN 

33 
 
 Study Proposal 
 
Version 1.5 vom 03.12.18 
 
Physical Ex-
amination 
procedure 
 
 
 
 
 
Manual 
muscle 
strength 
Test 
 
 
 
 
 
 
Passive hip 
joint mobili-
zation 
Potential irritation/pain 
provocation/tissue dam-
age of patient being ex-
amined 
 
 
 
 
Potential damage/physical 
overload due to maximal 
isometric contraction  
 
 
 
 
 
 
 
 
Potential irritation/pain 
provocation/tissue dam-
age of patient being 
treated 
Low 
 
 
 
 
 
 
Low 
 
 
 
 
 
 
 
 
 
 
Low 
 
The procedure will be conducted by an experi-
enced physiotherapist in a clinical setting 
(physiotherapy practice) that conforms to the 
Austrian guidelines that are required for work-
ing with patients in a physiotherapeutic set-
ting. If any signs of potential harm are present, 
the examiner will not perform any further 
tests and exclude the potential participant. 
 
Patients with any relevant pathology (systemic 
diseases, severe osteoporosis, fractures..) or 
pregnancy will be excluded prior to the meas-
urement. As the examiner is trained in the use 
of a HHD, there is no additional risk in using 
this apparatus within the strength test (other 
than it could be inconvenient for the patient 
on his/her skin, which will be checked with the 
patient). To ensure that the movement will be 
done correctly, two practice trials will be per-
formed under the supervision of the re-
searcher. 
 
Again, performed by an experienced physio-
therapist within a clinical setting. The intensity 
of the mobilisation will be moderate and with-
out pain provocation. Patients will be encour-
aged beforehand to tell if anything is incon-
venient for them. 
The screening/testing procedures and the in-
terventions within this research project in-
volve standard tests/techniques that any phys-
iotherapist may conduct in the course of a 
clinical examination 
 
Please keep this form in your Site File (Section 3 - Ethics) and update as appropriate. 
 
Project Files and Site Files 
All studies require a file with the administrative details such as letters and consent forms.  If it is a 
non-NHS project then these are called 'project files', if an NHS project they are called 'site files'.  They 
contain more or less the same things - for details see in the ethics folder on the BlackBoard site. 
 
 
 
 

34 
 
 Study Proposal 
 
Version 1.5 vom 03.12.18 
 
Appendix 9 
First Contact/Examination Data sheet: 
 
Variable 
Data 
checklist_obj 
 
slsq 
 
strength 
 
p_rom 
left (_l) 
right (_r) 
flex 
 
 
er90  
 
 
ir90 
 
 
abd 
 
 
add 
 
 
ext 
 
 
er0 
 
 
ir0 
 
 
Variable 
Data 
id 
 
right 
 
female 
 
age 
 
weight 
 
height 
 
checklist_subj 
 
lumb_p 
 
ank_p 
 
pregn 
 
rel_dis 
 

35 
 
 Study Proposal 
 
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Post-Test Data sheet: 
 
 
Variable 
Data 
pretest_1_i 
 
pretest_1_ii 
 
pretest_1_iii 
 
pretest_1_pain 
 
posttest_1_i 
 
posttest_1_ii 
 
posttest_1_iii 
 
posttest_1_pain 
 
subj_change_1 
 
p_rom_change_1_* 
 
p_rom_change_1_* 
 
p_rom_change_1_* 
 
 
 
 
 
pretest_2_i 
 
pretest_2_ii 
 
pretest_2_iii 
 
pretest_2_pain 
 
posttest_2_i 
 
posttest_2_ii 
 
posttest_2_iii 
 
posttest_2_pain 
 
subj_change_2 
 
p_rom_change_2_* 
 
p_rom_change_2_* 
 
p_rom_change_2_*