Comparison of the Effects of Basic Body Awareness Therapy to Conventional Physiotherapy and Home Exercise Program in Individuals With Knee Osteoarthritis
Phase: NA
Conditions: Knee Osteoarthritis
Sponsor: Hacettepe University

HACETTEPE UNIVERSITY 
FACULTY OF PHYSICAL THERAPY AND 
REHABILITATION 
COMPARISON OF THE EFFECTS OF BASIC BODY AWARENESS 
THERAPY TO CONVENTIONAL PHYSIOTHERAPY AND HOME 
EXERCISE PROGRAM IN INDIVIDUALS WITH KNEE OSTEOARTHRITIS 
PRINCIPAL INVESTIGATOR 
Emine Esra DİKMEN, PT, MSc 
INVESTIGATORS 
Filiz CAN, PhD, PT, PhD, Prof
Study Type: Randomised Controlled Clinical Trial 
Ankara, Turkey / 2026 
Approved by Approved by Hacettepe University Faculty of Physical Therapy and Rehabilitation Ethics Committee 
(Approval Number: FTREK25/136) 
30/01/2026

STUDY PROTOCOL 
1. Study Title
Comparison of the Effects of Basic Body Awareness Therapy to Conventional Physiotherapy and 
Home Exercise Program in Individuals with Knee Osteoarthritis 
2. Background and Aim
Osteoarthritis (OA) is a common chronic musculoskeletal condition that predominantly affects 
weight-bearing joints such as the knee and hip, leading to pain, functional limitations, and reduced 
quality of life. Exercise therapy and physiotherapy-based interventions are recommended as first-
line treatments in the conservative management of knee osteoarthritis due to their effectiveness in 
reducing pain and improving function. However, long-term adherence to conventional exercise 
programs remains challenging for many patients. 
Basic Body Awareness Therapy (BBAT) is a body–mind–oriented therapeutic approach that focuses 
on movement quality, postural control, breathing, and body awareness. BBAT aims to enhance self-
efficacy, promote efficient movement patterns, and support active patient involvement in 
rehabilitation. Owing to its holistic nature, minimal equipment requirements, and suitability for 
group-based application, BBAT may represent a sustainable and accessible alternative exercise 
method for individuals with knee osteoarthritis. Nevertheless, evidence regarding its effectiveness in 
this population is limited. 
This randomized controlled clinical trial aims to compare the effects of BBAT combined with a 
home exercise program, conventional physiotherapy combined with a home exercise program, and a 
home exercise program alone on pain, physical function, proprioception, balance, muscle strength, 
range of motion, kinesiophobia, fatigue, and quality of life in individuals with knee osteoarthritis. 
3. Methods: Study Design and Interventions
3.1. Study Setting 
All study procedures, including participant assessment and treatment, will be conducted at the 
Orthopedic Rehabilitation Unit, Faculty of Physical Therapy and Rehabilitation, Hacettepe 
University. 
3.2. Study Period 
The study period has been defined as year of 2026 covering all phases of the research. 
3.3. 3.3. Participants and Sample Size Calculation 
Participants will be recruited from the Orthopedic Rehabilitation Unit of the Faculty of Physical 
Therapy, Hacettepe University. Sample size was calculated using G*Power 3.1 based on the minimal 
clinically important difference of the WOMAC scale. With an alpha level of 0.05 and a power of 0.90, 
the required sample size was determined as 21 participants per group. All eligible individuals were 
informed about the study procedures, and written informed consent was obtained prior to participation. 
Inclusion Criteria 
•
Grade 2–3 knee osteoarthritis (Kellgren–Lawrence)
•
Age 40–74 years
•
Fulfillment of ACR diagnostic criteria

Exclusion Criteria 
•
Systemic inflammatory rheumatic disease
•
Fixed lower extremity deformity or joint contracture
•
Previous knee or hip surgery
•
Neurological disorders affecting lower extremity function
•
Inflammatory or infectious joint conditions
•
Physical therapy, exercise program, or injection treatment within the last 6 months
•
Regular exercise (≥3 days/week)
•
Regular NSAID or corticosteroid use
•
Severe cognitive or psychiatric disorders
•
Cancer or pregnancy
•
Non-adherence to the exercise program
Participants were assigned to the intervention groups using block randomization to ensure balanced 
group allocation. Randomization was performed after baseline assessment. 
3.4. Study Type 
•
Randomised Controlled Clinical Trial
3.5. Study Design 
This study was designed as a three-arm randomized controlled clinical trial. Participants were 
randomly allocated into one of three intervention groups: 
(1) Basic Body Awareness Therapy (BBAT) plus home exercise,
(2) Conventional physiotherapy plus home exercise, or
(3) Home exercise only (control group).
The intervention period lasted six weeks, with supervised sessions conducted twice weekly. The 
total program duration was eight weeks. Outcomes were assessed at baseline and immediately after 
completion of the intervention. 
Interventions 
Basic Body Awareness Therapy (BBAT) Group 
Participants in the BBAT group received group-based BBAT sessions twice weekly for six weeks, 
administered by a physiotherapist certified by the Institute of Basic Body Awareness Therapy (IBK). 
The program included progressively introduced exercises focusing on body alignment, breathing, 
postural control, and movement awareness in supine, standing, and functional positions. Participants 
also followed the standardized home exercise program. 
Conventional Physiotherapy Group 
Participants in the conventional physiotherapy group received standard physiotherapy interventions, 
including hot pack application, therapeutic ultrasound, and supervised exercise therapy, twice 
weekly for six weeks. The same home exercise program was prescribed. 
Home Exercise Program Group 
Participants in the home exercise group performed an exercise program based on international 
guidelines (ACSM, OARSI, AAOS, ESCEO, and EULAR). The program included strengthening, 

flexibility, aerobic, neuromotor exercises, and patient education. Exercise adherence was monitored 
using exercise diaries. 
Outcome Measures 
All outcome measures were assessed before and after the intervention period. Primary outcomes 
included pain severity, pressure pain threshold, pain catastrophization, active joint position sense, 
knee function, physical mobility, balance and muscle strength. Secondary outcomes included range 
of motion, kinesiophobia, fatigue, edema, aerobic and physical performance and quality of life. 
Data Management and Confidentiality 
All collected data were stored securely in password-protected electronic files accessible only to the 
research team. Participant confidentiality was strictly maintained, and personal identifiers were 
removed prior to data analysis. 
Study Completion Criteria 
The study was considered complete after post-intervention assessments were obtained from all 
participants. Withdrawal from the study, failure to adhere to the intervention protocol, or absence 
from three consecutive sessions were recorded as secondary outcomes 
 3.6. Statistical Analysis 
Statistical analysis will be performed using the Statistical Package for the Social Sciences (SPSS) 
software (version XX.0; IBM Corp., Armonk, NY, USA). Descriptive statistics will be calculated 
for all variables. Continuous variables will be presented as mean ± standard deviation or median 
(interquartile range), depending on data distribution, while categorical variables will be expressed as 
frequencies and percentages. Normality of data distribution will be assessed using the Shapiro–Wilk 
test and visual inspection of histograms. Between-group differences at baseline will be analyzed 
using one-way analysis of variance (ANOVA) for normally distributed variables or the Kruskal–
Wallis test for non-normally distributed variables. Categorical variables will be compared using the 
chi-square test. Within-group comparisons before and after the intervention will be analyzed using 
paired t-tests or Wilcoxon signed-rank tests, as appropriate. Between-group differences in outcome 
measures over time will be evaluated using repeated-measures ANOVA or mixed-model analysis. In 
the presence of significant main or interaction effects, post hoc analyses with appropriate correction 
methods will be applied. The level of statistical significance will be set at p < 0.05. All analyses will 
be conducted according to the intention-to-treat principle. 

INFORMED CONSENT FORM
 Informed Voluntary Consent Form for Participants
You are invited to participate in a research study titled “Comparison of the Effects of Basic Body 
Awareness Therapy to Conventional Physiotherapy and Home Exercise Program in Individuals with Knee 
Osteoarthritis’’. This study has been approved by the Ethics Committee of the Faculty of Physical Therapy 
and Rehabilitation, Hacettepe University (approval date: 04.12.2025 / approval number: FTREK25/136) 
and is conducted by Filiz CAN PT, PhD, Prof and  Emine Esra DİKMEN PT, MSc.
Your participation in this study is entirely voluntary. You may choose not to participate or may 
withdraw from the study at any time without providing a reason and without any effect on your current or 
future medical care or patient rights. 
Before signing this form, please read the information carefully. There will be no cost to you for 
participating in this study, and no financial compensation will be provided. All data collected during the 
study will be used solely for research purposes and will be kept confidential. Study records may be reviewed 
by authorized monitors, ethics committees, or regulatory authorities when required. 
If you have any questions during the study or regarding your participation, you may contact the 
research team at any time using the contact information provided below. 
Reason for the Study 
The purpose of this study is to compare the effects of Basic Body Awareness 
Therapy, a novel therapeutic approach, with conventional physiotherapy in 
individuals with knee osteoarthritis. Specifically, the study aims to evaluate 
and compare the effects of these interventions on pain, knee function, fear of 
movement, balance, quality of life, muscle strength, deep sensation, joint 
range of motion, edema, functional mobility, and aerobic and physical 
performance. 
This study will be conducted within the Department of Musculoskeletal 
Physiotherapy and Rehabilitation, Faculty of Physical Therapy and 
Rehabilitation, Hacettepe University. Your participation is important for the 
successful completion of this research. 
Study Procedures 
If you agree to participate in this study, you will be examined by Filiz CAN PT, 
PhD, Prof or Emine Esra DİKMEN PT, MSc and your clinical findings will be 
recorded. Based on the initial assessment, eligibility for participation will be 
determined. If you meet the inclusion criteria, you will be enrolled in the study 
and randomly assigned to one of three study groups. 
Regardless of group allocation, all participants will follow a standardized home 
exercise program prescribed by a physiotherapist for a total duration of eight 
weeks. In addition, participants assigned to one of the two treatment groups 
will receive one of two physiotherapy and rehabilitation programs 
administered by a physiotherapist twice weekly for six weeks. At the beginning 
of the study, the content of the assigned treatment and exercise program will 
be explained and demonstrated in detail by the physiotherapist. 
All interventions and exercise programs used in this study are considered safe 
and are not expected to pose any risk to your health. On the contrary, the 
exercises and treatment approaches used in all three groups may have 
beneficial effects on knee pain and knee function. 
HACETTEPE UNIVERSITY 
FACULTY OF PHYSICAL THERAPY AND 
REHABILITATION 

With your consent, data will be collected before and after the intervention 
period. First, demographic information (such as age, height, weight, body mass 
index, medical and family history) will be recorded using a standardized data 
collection form. Subsequently, you will be asked to complete ten 
questionnaires assessing pain, knee function, fear of movement, balance, 
fatique and quality of life. 
Your pressure pain threshold will be measured using an algometer, a device 
that assesses sensitivity to pressure applied to the skin. Deep sensation related 
to knee movements will be evaluated using a photographic recording method 
during specific knee movement tasks. These photographs will not be shared 
with any third parties, will be stored on a password-protected computer, and 
will be analyzed using computer software. 
Joint range of motion will be measured using a goniometer, and lower 
extremity muscle strength will be assessed using a hand-held dynamometer 
applied externally over the skin. Functional mobility will be evaluated using the 
Timed Up and Go Test, while physical performance will be assessed using the 
Stair Climbing Test and the Six-Minute Walk Test. 
All assessments are non-invasive and will not cause pain, harm, or adverse 
effects. The total assessment duration will be approximately 70 minutes, 
including rest periods. If you experience fatigue, pain, balance problems, or 
discomfort during the assessments or exercises, the procedures will be stopped 
and resumed on another day if necessary. 
The exercises included in this study are designed to be low intensity and non-
strenuous, focusing on improving body awareness and movement control 
through simple movements. Mild discomfort or muscle soreness may occur 
during the initial adaptation period; this is considered normal and is expected 
to resolve over time. If pain or other symptoms become persistent or severe, 
the exercises will be discontinued, rest periods will be provided, or you may be 
withdrawn from the study if necessary. You may also withdraw from the study 
at any time at your own request. 
No significant risks are anticipated in this study. All procedures used are 
routinely and safely applied in clinical practice. Detailed information regarding 
the content and safety of the intervention corresponding to your assigned 
group will be provided. You will be encouraged to ask questions at any time, 
and all concerns will be addressed. Although no risks are expected, information 
regarding safety measures and the exercise environment will be provided to 
you and, if necessary, to your family. 
Basic Body Awareness Therapy will be administered by a physiotherapist who 
has successfully completed an internationally certified training program and 
holds official certification in this therapeutic approach. 
Study Location 
Orthopedic Rehabilitation Unit, Faculty of Physical Therapy and Rehabilitation, 
Hacettepe University 
Will any images and/or audio 
recordings be obtained?    
Yes  
  No 

PARTICIPANT STATEMENT 
I confirm that I have been informed about the purpose and content of the research study described above. 
Following this information, I have been invited to participate in the study as a participant. I have been 
assured that my identity will be kept confidential both during the conduct of the study and in any resulting 
publications. 
I voluntarily consent to the use of my data for research purposes. I have been informed that my personal 
information will be carefully protected during the use of study results for educational and scientific 
purposes. I understand that I may withdraw from the study at any time without providing a reason and that 
my legal patient rights will be fully preserved in the event of withdrawal. 
I understand that I will not incur any financial responsibility related to participation in this study and that 
no financial compensation will be provided. I confirm that I have fully understood all explanations provided 
to me regarding the study. I am participating in this study voluntarily, without any pressure or coercion. 
I understand that I may contact the researchers at any time using the contact information provided below 
if I have any questions during the study or regarding any aspect of the research. I acknowledge that a signed 
copy of this consent form will be provided to me. 
       Investigators 
Name-Surname-Title 
Filiz CAN PT, PhD, Prof 
Date and Signature 
Contact Information 
Hacettepe University Faculty of Physical Therapy and 
Rehabilitation Sıhhiye Campus 
06100 Samanpazarı/ANKARA  
+905324575652
Name-Surname-Title 
Emine Esra DİKMEN PT, MSc 
Date and Signature 
Contact Information 
Hacettepe University Faculty of Physical Therapy and 
Rehabilitation Sıhhiye Campus 
06100 Samanpazarı/ANKARA  
+905394063945
Participant 
Name-Surname 
Date and Signature 
Contact Information