Effect of Delorme Resistance Exercises Versus Treadmill Training on Locomotor Abilities in Cerebral Palsy
Phase: NA
Conditions: Cerebral Palsy
Sponsor: Ghurki Trust and Teaching Hospital

 
STUDY INFORMATION 
 
Title of Project: Effect of delorme resistance exercises versus treadmill training on 
locomotor abilities in cerebral palsy after Achilles tendon release (short title: Effect of 
Delorme Resistance Exercises Versus Treadmill Training in Cerebral Palsy) 
 
Principal Investigator:  
Name: Samreen Sadiq 
Division & Department: Lahore College of Physical therapy, Lahore Medical and Dental College 
Contact Information: Telephone Number & Email Address 
0333-4371715; samreen.sadiq@lmdc.edu.pk 
 
PROTOCOL VERSION: Version #1; 25 Oct 2018 
 
ClinicalTrials.gov ID: NCT03755648 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
1.0 Research Introduction  
 
1.1 Purpose/Specific Aims  
 
To determine the effect of delorme resistance exercises versus treadmill training on locomotor 
abilities in cerebral palsy children  
A. Objectives 
 
The current study highlights the effect of treadmill training as compared to DeLorme resistance 
exercises on locomotor activities in cerebral palsy child after Achilles tendon lengthening. The 
present study would add to the clinical knowledge of physical therapists by promoting the 
implementation of treadmill training and DeLorme resistance exercises for this prevalent 
pediatric neurodevelopmental disorder and adding data to compare the effectiveness of both 
interventions. The study would decrease the burden of disease among community and enhance 
the social participation of cerebral palsy children. This in turn would improve the quality of 
living of these disabling diseased children. 
B. Hypothesis/ Research Questions 
We hypothesized that delorme resistance exercises along with traditional therapy will be 
equally effective as compared to treadmill training plus traditional therapy on locomotor 
abilities among children with spastic cerebral palsy after Achilles tendon release 
1.2 Research Significance 
Cerebral palsy is defined as a cluster of non-progressive motion and posture disorder resulting 
from irreversible damage to immature brain. The neurological deficit related to Cerebral Palsy is 
irreversible, muscular fatigue, musculoskeletal limitations and pain are found to be contributory 

factors in cerebral palsy children that may incorporate a decline in locomotion(1).Cerebral palsy 
is one of the most important source of disability among children and its incidence is almost 3.6 in 
thousand live births(2). Children with Cerebral Palsy presents with ambulatory difficulties. The 
attainment of independent and efficient locomotion is important for musculoskeletal growth and 
cardiopulmonary progress as well as for functional activities. Therefore, it is an essential aim of 
rehabilitation in these children(3). 
Cerebral palsy children have frequent gait abnormalities secondary to development for which 
there is intense need for surgical corrections. Excessive Achilles tendon lengthening results in 
paresis of gastrosoleus and Achilles tendon that contribute to compromised locomotor 
abilities(4). The cerebral palsy children substitute the functional activities by utilizing alternate 
movement strategies. The development and persistence of compensatory patterns direct the goal 
of physical therapist towards minimizing these patterns. Thus ensuring improved muscle 
coordination and enhanced locomotor activities(5). Strength building resulting from DeLorme 
resistance exercises is significant for recurrence prevention and for enhancing the muscular 
performance(6).  
Treadmill training is a fairly new approach that is utilized to efficiently train ambulation in 
Cerebral Palsy children. It stimulates repetitive stepping in an upright position with support, 
bearing weight on lower limb. It also enhances strength of lower extremity and improve balance 
reactions which aid in the locomotion process.(7) 
The combined effect of treadmill and endurance training results in significant improvement in 
strength of muscles and prevents the recurrence of injuries as well as facilitates the rehabilitation. 
Therefore they play an important role in maintaining the functional capacity thus leading to 
improved fundamental activities of daily living. In addition, these resistive exercises along with 

strength also improve balance of the cerebral palsy children ensuing increased social 
participation. Strength development resulting from these interventions enhances locomotor 
abilities of the child enabling them to play, work and perform daily life activities efficiently.  
Insufficient evidences are available on treadmill training in pediatric population. The current 
study highlights the effect of treadmill training as compared to DeLorme resistance exercises on 
locomotor activities in cerebral palsy child. The present study would add to the clinical 
knowledge of physical therapists by promoting the implementation of treadmill training and 
DeLorme resistance exercises for this prevalent pediatric neurodevelopmental disorder. The 
study would decrease the burden of disease among community and enhance the social 
participation of cerebral palsy children. This in turn would improve the quality of living of these 
disabling diseased children. 
1.3 Research Design and Methods  
OVERVIEW 
This is a single blinded Randomized Clinical trial to compare the effects of delorme resistance 
exercise versus treadmill training on locomotor abilities in spastic cerebral palsy children after 
Achilles Tendon Release. The study will be conducted at Dimensions Institute for Special 
Education and Psychological Services. There will be eligibility criteria and random assignment 
of participants to groups through simple random sampling. 
 
 
 
 
 
RECRUITMENT 
  
Eligibility Criteria 
Informed Consent 
Inclusion/Exclusion Criteria 
Group Assignment 
     Cerebral Palsy Children 
 
Group A                   Group B 

Children will be recruited from three different settings including 1 tertiary care hospital and two 
special schools. Consent will be taken from institution, guardians of the children and 
participants. Principal Investigator will provide an overview and basic purpose of the study. The 
final selection of the participants will be based on the eligibility criteria and participant 
willingness to participate in the study.  
ELIGIBILITY SCREENING 
Participants will be evaluated for eligibility screening. Informed consent will be taken from 
children and parents prior to eligibility process. A Member of research team will provide 
complete information, aim, objectives and importance of the project to parents and children. The 
baseline characteristics of children will be Gross Motor Functional Scale Level II and III and 
those with ability to understand commands and directions. Those children with Achilles Tendon 
lengthening procedure3 to 6 months postoperatively will be included in the study and those who 
had never undergone treadmill training before. The diplegic type of cerebral palsy who had 
undergone bilateral Tendon of Achilles Lengthening will be recruited. The exclusion criteria will 
be subjects presenting with other types of CP, Children with audiovisual impairment that can 
hinder the treatment, leg length discrepancy greater than 2 cm, fixed contractures, joint 
instability and associated cardiovascular condition. 
GROUP ASSIGNMENT  
Upon confirmation of eligibility criteria, the Principal Investigator will randomly assign children 
to two equal groups namely Group A and B. Group A will receive treadmill training along with 
traditional physiotherapy and Group B will receive delorme resistance exercise with traditional 
physiotherapy 
LOCOMOTOR ABILITY ASSESSMENT 

Locomotor ability will be assessed using ABILOCO-kids questionnaire. It consisted of 10 
locomotion activities of which difficulty was rated by the parents. It has good reliability r=0.97 
and reproducibility of 0.96. Parent will be asked to fill in questionnaire by estimating their child's 
ease or difficulty in performing each activity. Activities will be presented in 10 different random 
orders to avoid any systematic effect. During evaluation, 3-level response scale will be presented 
to parent. Parent will be asked to rate his perception on response scale as 'Impossible', 'Difficult' 
or 'Easy'. Activities not attempted by child within last 3 months are not scored and are entered as 
not applicable. Activities that child doesn’t perform because they are too difficult must be scored 
as 'Impossible'. Child's locomotion ability and its 95% confidence interval are located on 
locomotion ability scale expressed in logits. Higher the ability of a child the more the measure 
will be located to the right. 
1.4 Sample Size justification 
The sample size is calculated by WHO Sample Size calculator keeping the level of significance 
as 5%, standard deviation as 4.35 and power of study kept at 90%. 
1.5 Study Variables 
 A. Independent Variables, Interventions, or Predictor Variables  
The independent variable will be treadmill training, delorme resistance exercise, cerebral palsy. 
B. 
Dependent Variables or Outcome Measures  
The outcome measure will be Locomotor abilities 
1.6 Drugs/Devices/Biologics 
 N/A  
1.7 Primary Specimen Collection 
 N/A  

1.8 Interviews, Focus Groups, or Surveys  
N/A 
1.9 Time table of events 
 
July 
2018 
Aug 
2018 
Sep 
2018 
Oct  
2018 
Nov  
2018 
Dec 
2018 
Staff/student 
training, 
departmental 
setup, 
research 
material 
development  
 
 
 
 
 
 
Recruitment 
 
 
 
 
 
 
Eligibility screening and 
group assignment 
 
 
 
 
 
 
Testing 
 
 
 
 
 
 
Data analyses 
 
 
 
 
 
 
Write 
up, 
results 
dissemination and record 
archiving 
 
 
 
 
 
 
 
2.0 Project Management 
 2.1 Research Staff  
Principal Investigator: Dr. Samreen Sadiq 
Co-Investigator: Dr. Iqra Khan 
Co- Investigator: Dr. Hafiz Asim 
Co-Investigator: Dr. Amer Aziz 
Co-Investigator: Dr. Samia Sarmad 

 
 
2.2 Resources Availability 
 
2.1 Facilities: Research will be conducted in Dimensions Institute for Special Education and 
Psychological Services. It is equipped with modalities and treatment areas.  
2.2 Research Training:  Principal Investigator will complete the entire treatment process 
along with co investigatpr 
 
2.3 Multi-Site Research Communication & Coordination: N/A 
 
3.0 Research Data Source/s  
3.1 Primary Data-Subjects and Specimens  
Male and female children  
3.2 Subject Selection and Enrollment Considerations  
A. Recruitment Details  
Recruitment of participants was completed (received IRB approval). Participants were recruited 
through a special institute dimensions. Co investigator provided an overview of the study and 
described the broad selection criteria.  
B.Subject Selection 
Inclusion Criteria: 
 
Children with Gross Motor Functional Scale Level II and III 
 
Ability to understand commands and directions 

 
Diplegic type of cerebral palsy 
 
Children who had undergone bilateral Tendon of Achilles Lengthening procedure 3 to 6 
months post-operatively 
Exclusion Criteria: 
 
Children presenting with other types of Cerebral Palsy 
 
Children with audiovisual impairment that can hinder the treatment 
 
leg length discrepancy greater than 2 cm, 
 
Fixed contractures, joint instability and associated cardiovascular condition 
3.3 Subject Randomization  
Participants will be randomized through simple random number table. They will be 
assigned to Group A treadmill training plus traditional therapy and group B deLorme 
resistance exercise plus traditional therapy.  
3.4 Secondary Subjects  
N/A  
3.5 Number of Subjects  
A. Total Number of Subjects  
50 
B. Total Number of Subjects If Multicenter Study  
N/A 
C. Require Number of Subjects to Complete Research: 44 
 

 
 
4.0 Bibliography 
1.   Palisano RJ, Hanna SE, Rosenbaum PL, Tieman B. Probability of walking, wheeled 
mobility, and assisted mobility in children and adolescents with cerebral palsy. Developmental 
Medicine & Child Neurology. 2010;52(1):66-71. 
2. 
Sarhan RS, Chevidikunnan MF, Gaowgzeh RAM. LOCOMOTOR TREADMILL 
TRAINING PROGRAM USING DRIVEN GAIT ORTHOSIS VERSUS MANUAL 
TREADMILL THERAPY ON MOTOR OUTPUT IN SPASTIC DIPLEGIC CEREBRAL 
PALSY CHILDREN. Nitte University Journal of Health Science. 2014;4(4):10. 
3. 
Chrysagis N, Skordilis EK, Stavrou N, Grammatopoulou E, Koutsouki D. The effect of 
treadmill training on gross motor function and walking speed in ambulatory adolescents with 
cerebral palsy: a randomized controlled trial. American journal of physical medicine & 
rehabilitation. 2012;91(9):747-60. 
4. 
Natarajan R, Ribbans W. Achilles tendon involvement in pediatric conditions. The 
Achilles Tendon New York, NY: Springer. 2007:236-51. 
5. 
Dale RB, Harrelson G, Leaver-Dunn D. Principles of rehabilitation. Physical 
Rehabilitation of the Injured Athlete. 2012:157-88. 
6. 
Graham A, Reid G. Physical fitness of adults with an intellectual disability: A 13-year 
follow-up study. Research quarterly for exercise and sport. 2000;71(2):152-61. 
7. 
Damiano DL, DeJong SL. A systematic review of the effectiveness of treadmill training 
and body weight support in pediatric rehabilitation. Journal of neurologic physical therapy: 
JNPT. 2009;33(1):27.