Knee OsteoarthritisNCT07395427
Comparison of the Effects of Basic Body Awareness Therapy in Individuals With Knee Osteoarthritis
A study testing BBAT plus home exercise programme, Conventional physiotherapy plus home exercise programme and Home exercise programme in people with Knee Osteoarthritis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Osteoarthritis (OA) is a chronic, degenerative joint disease associated with aging and is recognized by the World Health Organization as a primary health condition. It is one of the leading causes of chronic disability worldwide. Read more about this study
- Who is it for?
- Ages 40 to 74 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- BBAT plus home exercise programme, Conventional physiotherapy plus home exercise programme and Home exercise programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Dec 2025to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Grade 2-3 knee osteoarthritis based on the Kellgren-Lawrence radiographic grading system.
- Aged between 40 and 74 years.
- Meeting the clinical classification criteria of the American College of Rheumatology (ACR).
Who cannot join
- Current or previous history of malignancy.
- Pregnancy or lactation.
- History of prior surgical intervention involving the knee or hip joints.
- Presence of neurological disorders impacting the innervation of the hip or knee musculature.
- Presence of concomitant inflammatory or infectious pathologies localized to the hip or knee joints.
- Having undergone physical therapy or rehabilitation interventions within the preceding 6 months.
Show all 9Show fewer
- Administration of intra-articular injections (PRP, GRP, stem cell or corticosteroids) within the last 6 months.
- Severe cognitive impairment or diagnosis of dementia.
- Participation in regular physical exercise or sports activities for a minimum of 3 days per week.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Hacettepe University/Faculty of Physical Therapy and Rehabilitation/ Orthopedic Rehabilitation Unit
Ankara, Ankara, 06050
About this study
Official title: Comparison of the Effects of Basic Body Awareness Therapy to Conventional Physiotherapy and Home Exercise Program in Individuals With Knee Osteoarthritis
Osteoarthritis (OA) is a chronic, degenerative joint disease associated with aging and is recognized by the World Health Organization as a primary health condition. It is one of the leading causes of chronic disability worldwide. Structural changes occurring at the bone and joint margins in OA lead to a variety of symptoms and clinical findings associated with the deterioration of articular cartilage integrity.
Clinical guidelines recommend a combination of exercise therapy tailored to individual needs, weight loss, and patient education prior to considering arthroplasty. However, achieving satisfactory long-term outcomes remains challenging, as patients are often unmotivated to adhere to training programs involving functional strength and mobility exercises unless they are supervised by a physiotherapist. Basic Body Awareness Therapy (BBAT) may serve as an alternative exercise method with a higher potential for sustained effects.
Read more
BBAT is a movement-based therapy applied to daily life activities, focusing on body alignment and movement quality. Through the learning process of BBAT-by doing, reflecting, and transferring body awareness into everyday movements-it is hypothesized that patients gain self-efficacy and skills essential for maintaining independent and continuous exercise. BBAT is a body-mind therapeutic approach that emphasizes awareness of body sensations and movement patterns, aiming to restructure body awareness and motor control through individual experience. Increased attention to movement and bodily experiences enhances awareness of both physical and mental aspects.
Through specific exercises, BBAT helps to reveal and improve the interaction and synergy between body and mind, thereby promoting postural stability, movement fluidity, and awareness of bodily reactions and internal resources. By encouraging reduced energy expenditure during daily activities and improving movement quality through self-exploration and experiential learning, BBAT contributes to improvements in postural imbalance, muscle tension, and bodily dysfunction. BBAT movements are simple, comfortable, balanced, and based on repeated experiential learning. Exercises are performed in various positions, including lying, sitting, standing, and walking. Physiotherapists guide patients using both physical and verbal cues to facilitate improved postural control, balance, and breathing during movement.
Central sensitization may lead individuals with osteoarthritis to perceive normal bodily functions as painful, resulting in compensatory and dysfunctional movement strategies. It has been reported that mindfulness-based and body-mind therapies can reduce pain and symptoms while improving physical function in clinical management. Moreover, as emphasized in the recommendations of the Osteoarthritis Research Society International (OARSI), active patient involvement in health management is a core component of body-mind therapies such as BBAT.
Despite these potential benefits, there is a limited number of studies investigating the effects of BBAT in individuals with osteoarthritis. Given that BBAT requires no equipment, can be practiced in any setting, promotes social engagement through group-based sessions, enhances relaxation and mind-body awareness, and reduces stress and anxiety, it may represent a favorable alternative exercise model. Additionally, BBAT may improve exercise adherence and contribute to reducing healthcare burden and associated costs. Comparing the effects of different therapeutic programs across multiple outcome parameters may help identify the most effective interventions for individuals with osteoarthritis, thereby improving clinical outcomes.
In this context, the present study aims to compare the effects of Basic Body Awareness Therapy, applied in addition to conventional physiotherapy and a home exercise program, on pain, muscle strength, range of motion, balance, active joint position sense, functional outcomes, pressure pain threshold, kinesiophobia, and quality of life in individuals with knee osteoarthritis.
Read the detailed description
This study is designed as a three-arm randomized controlled clinical trial to evaluate the effectiveness of Basic Body Awareness Therapy (BBAT) compared with conventional physiotherapy and a home exercise program in individuals with knee osteoarthritis. Eligible participants will be randomly allocated to one of three intervention groups: (1) BBAT plus home exercise, (2) conventional physiotherapy plus home exercise, or (3) home exercise only.
The intervention period will last six weeks, with a total program duration of eight weeks. BBAT and conventional physiotherapy interventions will be delivered twice weekly by licensed physiotherapists according to standardized treatment protocols. BBAT sessions will be conducted in group settings and will focus on body awareness, posture, breathing, and controlled movement patterns. Participants in all groups will follow the same structured home exercise program.
Outcome assessments will be conducted at baseline and after completion of the intervention period. Primary and secondary outcomes will include pain intensity, proprioception, functional status, balance, physical performance, muscle strength, joint range of motion, edema, fatigue, kinesiophobia, and quality of life. These outcomes will be evaluated using validated clinical assessment methods and patient-reported outcome measures.
The primary objective of this study is to compare the effects of BBAT, conventional physiotherapy, and home exercise on clinical and functional outcomes in individuals with knee osteoarthritis.
- Conditions
- Knee Osteoarthritis
- Being tested
- BBAT plus home exercise programme, Conventional physiotherapy plus home exercise programme, Home exercise programme
- Keywords
- knee osteoarthritis, mind-body therapy, exercise, proprioception, physiotherapy
- Medical subject headings
- Osteoarthritis, Knee, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBAT plus home exercise programmeOther
The participants will undergo Basic Body Awareness Therapy (BBAT) for a total of 12 sessions, conducted as two non-consecutive sessions per week over a 6-week period. Each active exercise session will last between 30 and 45 minutes. The body awareness training will specifically focus on lower extremity exercises and will follow a progressive protocol. The program will commence with 5 exercises in the first week, adding one new exercise each week to reach a total of 10 BBAT exercises. Initially, repetitions will be set at 5; subsequently, each exercise will be adjusted to range between 5 and 10 repetitions. In addition to the supervised treatment, participants will be requested to perform home exercises at home at least 3 days a week as 2 sets for a duration of 8 weeks, and an exercise diary will be provided. Prior to the treatment, the importance and content of the exercises will be thoroughly explained.
Conventional physiotherapy plus home exercise programmeOther
Also called traditional physiotherapy, classic physiotherapy
Before each treatment session, a hot pack (thermotherapy) will be applied to the knee, calf, and thigh muscles for 20 minutes, followed by therapeutic ultrasound administered to the periarticular knee region for 10 minutes in pulsed mode, with a frequency of 1.0 MHz, an intensity of <1 W/cm², and a total dose of <150 J/cm². Exercises and recommendations identical to those prescribed for the home exercise group will be explained to the patients, and they will be instructed to perform these exercises in addition to the treatment, for 8 weeks, at least 3 days per week, in 2 sets per session. An exercise diary will be provided to monitor adherence. Prior to treatment, participants will be informed about the importance and content of the exercise program.
Home exercise programmeOther
Also called home-based exercise programme
Based on the guidelines published by the American College of Sports Medicine (ACSM), Osteoarthritis Research Society International (OARSI), American Academy of Orthopaedic Surgeons (AAOS), European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO), and the European Alliance of Associations for Rheumatology (EULAR), participants will be prescribed a total of 12 home-based exercises to be performed over 8 weeks, at least 3 days per week, in 2 sets per session, with the number of repetitions progressively increased .
These exercises and recommendations will be categorized under the subheadings of aerobic exercise, muscle strengthening, flexibility, neuromotor performance, and patient education. To enhance exercise adherence and facilitate follow-up, participants will be provided with an exercise diary. The diary will include a 3-month calendar schedule, illustrations of the exercises, and coded numerical markers correspo
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | BBAT plus home exercise programme Receives: Other: BBAT plus home exercise programme |
| Group B | Active comparator | Conventional physiotherapy plus home exercise programme Receives: Other: Conventional physiotherapy plus home exercise programme |
| Group C | Active comparator | Home exercise programme Receives: Other: Home exercise programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength / Hand-held dinamometer - Lafayette Instrument®, Lafayette, IN
Lower extremity muscle strength will be evaluated using a hand-held dynamometer (Lafayette Instrument®, Lafayette, IN) via maximal voluntary isometric contraction (the "make" test) and recorded in kilograms/Newtons. The assessment will include the muscle strength of hip flexion, extension, abduction, adduction, external and internal rotation; knee flexion and extension; and ankle plantar/dorsi flexion. Participants will be given the command: 'Hold as strongly as possible without moving your leg.' For each movement, three measurements will be performed (5-second contraction, 30-second rest), and the average values of these measurements will be calculated.
Measured: 8 weeks
Balance - Fullerton Advanced Balance Scale (FAB-T)
The scale evaluates both static and dynamic balance under altered sensory conditions (soft surface, firm surface, decreased or increased support base, and verbal commands). It is specifically designed to measure balance in high-functioning, active older adults. The scale consists of 10 items, each scored between 0 and 4. A total score of 25 or below indicates a high risk of falling.
Measured: 8 weeks
Pain Severity - The Numerical Rating Scale (NRS)
Pain severity over the past 24 hours (at its worst, at its best, and at rest) will be assessed via the Numeric Rating Scale (NRS) on a scale of 0 to 10, where 0 represents 'no pain' and 10 represents 'the worst imaginable pain.
Measured: 8 weeks
Active Joint Position Sense (AJPS)
AJPS will be evaluated via photo-analysis using MATLAB and an iPhone 13 (50 cm distance, tripod, laser alignment). Anatomical markers (2x2 cm kinesio-tape) will be placed on the greater trochanter, lateral knee joint line, superior patella, fibular neck, and lateral malleolus. Participants in the supine position, with hips neutral and eyes masked, will actively reproduce target knee flexion angles (40°, 60°, 90°). Reference and reproduced positions will be photographed; the angular difference will be recorded as the error angle. After practice trials, measurements will be captured during a 4-second static phase. Three trials per angle will be performed in randomized order with 10-second intervals, and averages will be calculated. To prevent fatigue and angular memory bias, 1-minute rest periods will be provided. All measurements will be standardized by an experienced physiotherapist.
Measured: 8 weeks
Knee Function (KOOS)
Knee Injury and Osteoarthritis Outcome Score (KOOS): Developed to assess knee injury and OA symptoms. It includes 42 items in 5 subscales: Pain, Symptoms, ADL, Sport/Rec, and QoL. Items are scored on a 0-4 Likert scale based on the past week. Each subscale is normalized to a 0-100 range.
Measured: 8 weeks
Physical Mobility - TUG Test
Timed Up and Go (TUG) Test: TUG assesses independent mobility and functional ability. Participants rise from a chair, walk 3 meters at a safe pace, turn, walk back, and sit down. The duration is recorded in seconds.
Results are interpreted as follows: ≤10 seconds indicates good balance and gait speed; 10-20 seconds indicates independence in outdoor mobility without aids; ≥20 seconds signifies impaired mobility, poor balance, and increased fall risk. The test provides a reliable measure of dynamic balance and functional performance in clinical populations. All procedures will be timed using a digital stopwatch and recorded.
Measured: 8 weeks
Pressure Pain Threshold (PPT)/ (JTECH Medical-Algometer Commander, USA)
Measurements will be performed while the participant is in the supine and prone positions using a pressure algometer. In the supine position, measurements will be taken from the distal 1/3 of the iliopsoas muscle, the proximal and distal (suprapatellar) portions of the rectus femoris muscle, the infrapatellar tendon, the medial and lateral fat pads, the distal 1/3 of the iliotibial band, the adductor tendons, and the medial retinaculum. In the prone position, measurements will be obtained from the sacroiliac joint, the muscle bellies of the gluteus medius and piriformis, the proximal 1/3 of the medial and lateral heads of the gastrocnemius, and the popliteus muscle belly. The probe of the algometer will be applied perpendicularly to the designated area, and the pressure will be increased gradually at a rate of 1 kg/s. The value at which the mechanical stimulus first transitions into a sensation of pain will be recorded. Three measurements will be taken at 30-second intervals.
Measured: 8 weeks
The Pain Catastrophizing Scale (PCS)
Pain Catastrophizing Scale (PCS): A 13-item self-report tool used to measure exaggerated negative thoughts about actual or anticipated pain. It assesses three dimensions: Rumination (items 8-11), Magnification (items 6, 7, 13), and Helplessness (items 1-5, 12). Rumination reflects preoccupation with pain, helplessness denotes an inability to cope, and magnification represents an intensified perception of pain threat.
Each item is rated on a 5-point Likert scale (0=not at all, 4=all the time). Total scores range from 0 to 52, where higher scores indicate greater catastrophizing. A total score of ≥30 is identified as the clinical cutoff point for significant pain catastrophizing. This scale is vital for evaluating the psychological impact of pain and its influence on recovery and movement-related fear in clinical research and rehabilitation settings.
Measured: 8 weeks
Knee Function (LYSHOLM)
Lysholm Knee Scoring Scale: Revised in 1985, it assesses 8 domains: limp, support, locking, instability, pain, swelling, stair climbing, and squatting. Total score (0-100) is categorized as Excellent (95-100), Good (84-94), Fair (65-83), or Poor (0-64).
Measured: 8 weeks
Knee Function (WOMAC)
Western Ontario \& McMaster Universities Osteoarthritis Index (WOMAC): A valid index for OA, recommended by OMERACT. It comprises 24 items across 3 sections: Pain (max 20), Stiffness (max 8), and Physical Function (max 68). Higher scores indicate increased pain, stiffness, and functional impairment. All scales will be administered by a physiotherapist to evaluate functional status and quality of life.
Measured: 8 weeks
Secondary outcomes (8)
Quality of Life / (World Health Organization Quality of Life Scale - Brief Form (WHOQOL-BREF)
WHOQOL-BREF: A 26-item cross-cultural tool assessing four domains: physical, psychological, social relationships, and environment. It includes two general items on perceived health and quality of life. Domains are scored from 0 to 100, where higher scores indicate better well-being.
Measured: 8 weeks
Kinesiophobia - Tampa Scale for Kinesiophobia (TSK)
The scale consists of 17 items designed to measure the fear of movement and (re)injury. It utilizes a 4-point Likert scale (1: Strongly disagree, 2: Disagree, 3: Agree, 4: Strongly agree). Items 4, 8, 12, and 16 are reverse-scored. Total scores range from 17 to 68, where higher scores indicate a greater degree of kinesiophobia (fear of movement).
Measured: 8 weeks
Aerobic and Physical Performance (Stair Climb Test)
A staircase consisting of 9 steps (16-20 cm height) with handrails will be used. Participants will be instructed to ascend and descend as quickly and safely as possible. The total completion time will be recorded in seconds. This test provides data on lower extremity muscle strength and balance.
Measured: 8 weeks
Edema Assesment (Tape Measure)
Edema assessment will be performed using the circumference measurement technique with a foldable, non-elastic, 7-mm wide tape measure. To ensure the measurement is unaffected by tension, the starting end of the tape will be held in the left hand while the other end is wrapped around the limb with the right hand, and the value aligning with the starting point will be recorded. Furthermore, during measurement, the starting point and the corresponding value will be aligned side-by-side rather than overlapping. Participants will wear shorts to facilitate the identification of anatomical landmarks. Since the patella is the reference point for the thigh, measurements will be taken from the mid-patella, as well as 5 and 10 cm superiorly and inferiorly from both legs. To minimize potential errors arising from incorrect positioning or varying tension, all measurements will be performed by the same researcher to ensure inter-rater reliability.
Measured: 8 weeks
Range of Motion (ROM) - (Universal Goniometer)
Goniometric Assessment: AROM and PROM of the hip and knee will be measured using standardized protocols. Hip flexion (supine, knee flexed) and extension (prone, knee extended) use the greater trochanter as the fulcrum. Abduction and adduction (supine) align the stationary arm with the ASIS line. Internal and external rotation are assessed in the sitting position with the fulcrum at the tibial tuberosity and the stationary arm perpendicular to the floor. Knee flexion is measured in the prone position with the fulcrum at the lateral femoral condyle. Precautions include maintaining pelvic stability and preventing compensatory movements such as lumbar lordosis or pelvic elevation. All measurements start from a 0° neutral position. This comprehensive 2026 clinical evaluation ensures precise documentation of joint mobility, essential for monitoring rehabilitation progress and functional recovery in musculoskeletal physical therapy.
Measured: 8 weeks
Fatique / Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
The FACIT-F is a 13-item self-report scale designed to evaluate fatigue and its impact on daily activities and functions. Originally developed to assess the relationship between anemia and fatigue in cancer patients, its validity and reliability have since been established across more than 70 published studies involving over 20,000 participants. Since 1995, it has been proven effective for various conditions, including Multiple Sclerosis, Rheumatoid Arthritis, Psoriasis, Parkinson's disease, and Paroxysmal Nocturnal Hemoglobinuria. The scale measures the level of fatigue experienced during the past 7 days. Each item is rated on a 5-point Likert scale (0: Not at all, 4: Very much). Total scores range from 0 to 52, where higher scores indicate lower levels of fatigue. Items 1, 2, 3, 4, 5, 6, 9, 10, 11, 12, and 13 are reverse-scored, while items 7 and 8 are scored directly. It is a cross-culturally validated tool approved for use in adults with chronic illnesses.
Measured: 8 weeks
World Health Organization Quality of Life - Older Adults Module (WHOQOL-OLD)
WHOQOL-OLD: A 24-item module specifically for older adults, consisting of six facets: Sensory Abilities, Autonomy, Past/Present/Future Activities, Social Participation, Death and Dying, and Intimacy. Items use a 5-point Likert scale, with facet scores ranging from 4 to 20. It evaluates the impact of aging on independence, social engagement, and mortality concerns. Increased total scores represent improved quality of life. Both scales provide a multidimensional profile of the participant's subjective well-being and are validated in Turkish. These instruments are essential for evaluating the holistic outcomes of geriatric rehabilitation and 2026 clinical standards in elderly care.
Measured: 8 weeks
Aerobic and Physical Performance (6-Minute Walk Test (6MWT))
The 6MWT is a submaximal exercise test used to evaluate aerobic capacity and endurance. The distance covered over 6 minutes is recorded. A 30-meter unobstructed corridor, cones, and a stopwatch are required. Participants may rest if needed, but the timer continues. Dyspnea intensity will be assessed using the Modified Borg Scale before and after the test. The Modified Borg Scale is a 0-10 rating scale (0: None, 10: Maximum) used to measure perceived exertion and dyspnea severity. It is highly reliable for determining exercise intensity and monitoring subjective fatigue pre- and post-session.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start8 Dec 2025
- Primary completion8 Dec 2025
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Control Clinical Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Esra DİKMEN, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395427
- Sponsor's protocol ID
- HU-FTR-EED-01
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient-level data are not publicly available due to privacy and confidentiality considerations. Individual participant data were not shared because they contain confidential and potentially identifiable information, and data sharing was not covered by the informed consent obtained from participants. Therefore, access to these data is restricted in accordance with ethical standards and data protection regulations.
Publications
Singh H, Arya S, Talapatra P, Lather K, Mathur R, Singhania A, Chaudhary V. Assessment of fatigue in rheumatoid arthritis (by Functional Assessment of Chronic Illness Therapy-Fatigue score) and its relation to disease activity and anemia. J Clin Rheumatol. 2014 Mar;20(2):87-90. doi: 10.1097/RHU.0000000000000073.
PubMed 24561411Eser S, Saatli G, Eser E, Baydur H, Fidaner C. [The reliability and validity of the Turkish Version of the World Health Organization Quality of Life Instrument-Older Adults Module (WHOQOL-Old)]. Turk Psikiyatri Derg. 2010 Spring;21(1):37-48. Turkish.
PubMed 20204903Power M, Quinn K, Schmidt S; WHOQOL-OLD Group. Development of the WHOQOL-old module. Qual Life Res. 2005 Dec;14(10):2197-214. doi: 10.1007/s11136-005-7380-9.
PubMed 16328900Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667.
PubMed 9626712Vlaeyen JW, Kole-Snijders AM, Rotteveel AM, Ruesink R, Heuts PH. The role of fear of movement/(re)injury in pain disability. J Occup Rehabil. 1995 Dec;5(4):235-52. doi: 10.1007/BF02109988.
PubMed 24234727Tuzun EH, Eker L, Aytar A, Daskapan A, Bayramoglu M. Acceptability, reliability, validity and responsiveness of the Turkish version of WOMAC osteoarthritis index. Osteoarthritis Cartilage. 2005 Jan;13(1):28-33. doi: 10.1016/j.joca.2004.10.010.
PubMed 15639634Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.
PubMed 3068365Celik D, Coskunsu D, Kilicoglu O. Translation and cultural adaptation of the Turkish Lysholm knee scale: ease of use, validity, and reliability. Clin Orthop Relat Res. 2013 Aug;471(8):2602-10. doi: 10.1007/s11999-013-3046-z. Epub 2013 May 11.
PubMed 23666590Lysholm J, Gillquist J. Evaluation of knee ligament surgery results with special emphasis on use of a scoring scale. Am J Sports Med. 1982 May-Jun;10(3):150-4. doi: 10.1177/036354658201000306.
PubMed 6896798Gul ED, Yilmaz O, Bodur H. Reliability and validity of the Turkish version of the knee injury and osteoarthritis outcome score-physical function short-form (KOOS-PS). J Back Musculoskelet Rehabil. 2013;26(4):461-6. doi: 10.3233/BMR-130406.
PubMed 23948834Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug;28(2):88-96. doi: 10.2519/jospt.1998.28.2.88.
PubMed 9699158Darnall BD, Sturgeon JA, Cook KF, Taub CJ, Roy A, Burns JW, Sullivan M, Mackey SC. Development and Validation of a Daily Pain Catastrophizing Scale. J Pain. 2017 Sep;18(9):1139-1149. doi: 10.1016/j.jpain.2017.05.003. Epub 2017 May 19.
PubMed 28528981Arden NK, Perry TA, Bannuru RR, Bruyere O, Cooper C, Haugen IK, Hochberg MC, McAlindon TE, Mobasheri A, Reginster JY. Non-surgical management of knee osteoarthritis: comparison of ESCEO and OARSI 2019 guidelines. Nat Rev Rheumatol. 2021 Jan;17(1):59-66. doi: 10.1038/s41584-020-00523-9. Epub 2020 Oct 28.
PubMed 33116279Skou ST, Roos EM. Physical therapy for patients with knee and hip osteoarthritis: supervised, active treatment is current best practice. Clin Exp Rheumatol. 2019 Sep-Oct;37 Suppl 120(5):112-117. Epub 2019 Oct 15.
PubMed 31621559Kolasinski SL, Neogi T, Hochberg MC, Oatis C, Guyatt G, Block J, Callahan L, Copenhaver C, Dodge C, Felson D, Gellar K, Harvey WF, Hawker G, Herzig E, Kwoh CK, Nelson AE, Samuels J, Scanzello C, White D, Wise B, Altman RD, DiRenzo D, Fontanarosa J, Giradi G, Ishimori M, Misra D, Shah AA, Shmagel AK, Thoma LM, Turgunbaev M, Turner AS, Reston J. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Care Res (Hoboken). 2020 Feb;72(2):149-162. doi: 10.1002/acr.24131. Epub 2020 Jan 6.
PubMed 31908149
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Basic Body Awareness Therapy to Conventional Physiotherapy and Home Exercise Program in Individuals With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07395427
- Acronym / sponsor ID
- HU-FTR-EED-01
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, mind-body therapy, exercise, proprioception, physiotherapy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- 8 Dec 2025 (actual)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Osteoarthritis (OA) is a chronic, degenerative joint disease associated with aging and is recognized by the World Health Organization as a primary health condition. It is one of the leading causes of chronic disability worldwide. Structural changes occurring at the bone and joint margins in OA lead to a variety of symptoms and clinical findings associated with the deterioration of articular cartilage integrity.
Clinical guidelines recommend a combination of exercise therapy tailored to individual needs, weight loss, and patient education prior to considering arthroplasty. However, achieving satisfactory long-term outcomes remains challenging, as patients are often unmotivated to adhere to training programs involving functional strength and mobility exercises unless they are supervised by a physiotherapist. Basic Body Awareness Therapy (BBAT) may serve as an alternative exercise method with a higher potential for sustained effects.
BBAT is a movement-based therapy applied to daily life activities, focusing on body alignment and movement quality. Through the learning process of BBAT-by doing, reflecting, and transferring body awareness into everyday movements-it is hypothesized that patients gain self-efficacy and skills essential for maintaining independent and continuous exercise. BBAT is a body-mind therapeutic approach that emphasizes awareness of body sensations and movement patterns, aiming to restructure body awareness and motor control through individual experience. Increased attention to movement and bodily experiences enhances awareness of both physical and mental aspects.
Through specific exercises, BBAT helps to reveal and improve the interaction and synergy between body and mind, thereby promoting postural stability, movement fluidity, and awareness of bodily reactions and internal resources. By encouraging reduced energy expenditure during daily activities and improving movement quality through self-exploration and experiential learning, BBAT contributes to improvements in postural imbalance, muscle tension, and bodily dysfunction. BBAT movements are simple, comfortable, balanced, and based on repeated experiential learning. Exercises are performed in various positions, including lying, sitting, standing, and walking. Physiotherapists guide patients using both physical and verbal cues to facilitate improved postural control, balance, and breathing during movement.
Central sensitization may lead individuals with osteoarthritis to perceive normal bodily functions as painful, resulting in compensatory and dysfunctional movement strategies. It has been reported that mindfulness-based and body-mind therapies can reduce pain and symptoms while improving physical function in clinical management. Moreover, as emphasized in the recommendations of the Osteoarthritis Research Society International (OARSI), active patient involvement in health management is a core component of body-mind therapies such as BBAT.
Despite these potential benefits, there is a limited number of studies investigating the effects of BBAT in individuals with osteoarthritis. Given that BBAT requires no equipment, can be practiced in any setting, promotes social engagement through group-based sessions, enhances relaxation and mind-body awareness, and reduces stress and anxiety, it may represent a favorable alternative exercise model. Additionally, BBAT may improve exercise adherence and contribute to reducing healthcare burden and associated costs. Comparing the effects of different therapeutic programs across multiple outcome parameters may help identify the most effective interventions for individuals with osteoarthritis, thereby improving clinical outcomes.
In this context, the present study aims to compare the effects of Basic Body Awareness Therapy, applied in addition to conventional physiotherapy and a home exercise program, on pain, muscle strength, range of motion, balance, active joint position sense, functional outcomes, pressure pain threshold, kinesiophobia, and quality of life in individuals with knee osteoarthritis.
Detailed description
This study is designed as a three-arm randomized controlled clinical trial to evaluate the effectiveness of Basic Body Awareness Therapy (BBAT) compared with conventional physiotherapy and a home exercise program in individuals with knee osteoarthritis. Eligible participants will be randomly allocated to one of three intervention groups: (1) BBAT plus home exercise, (2) conventional physiotherapy plus home exercise, or (3) home exercise only.
The intervention period will last six weeks, with a total program duration of eight weeks. BBAT and conventional physiotherapy interventions will be delivered twice weekly by licensed physiotherapists according to standardized treatment protocols. BBAT sessions will be conducted in group settings and will focus on body awareness, posture, breathing, and controlled movement patterns. Participants in all groups will follow the same structured home exercise program.
Outcome assessments will be conducted at baseline and after completion of the intervention period. Primary and secondary outcomes will include pain intensity, proprioception, functional status, balance, physical performance, muscle strength, joint range of motion, edema, fatigue, kinesiophobia, and quality of life. These outcomes will be evaluated using validated clinical assessment methods and patient-reported outcome measures.
The primary objective of this study is to compare the effects of BBAT, conventional physiotherapy, and home exercise on clinical and functional outcomes in individuals with knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Randomised Control Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: BBAT plus home exercise programmeBBAT plus home exercise programme |
| Group B | Active comparator | Other: Conventional physiotherapy plus home exercise programmeConventional physiotherapy plus home exercise programme |
| Group C | Active comparator | Other: Home exercise programmeHome exercise programme |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Grade 2-3 knee osteoarthritis based on the Kellgren-Lawrence radiographic grading system.
- Aged between 40 and 74 years.
- Meeting the clinical classification criteria of the American College of Rheumatology (ACR).
Key exclusion criteria (9 listed)
- Current or previous history of malignancy.
- Pregnancy or lactation.
- History of prior surgical intervention involving the knee or hip joints.
- Presence of neurological disorders impacting the innervation of the hip or knee musculature.
- Presence of concomitant inflammatory or infectious pathologies localized to the hip or knee joints.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BBAT plus home exercise programmeThe participants will undergo Basic Body Awareness Therapy (BBAT) for a total of 12 sessions, conducted as two non-consecutive sessions per week over a 6-week period. Each active exercise session will last between 30 and 45 minutes. The body awareness training will specifically focus on lower extremity exercises and will follow a progressive protocol. The program will commence with 5 exercises in the first week, adding one new exercise each week to reach a total of 10 BBAT exercises. Initially, repetitions will be set at 5; subsequently, each exercise will be adjusted to range between 5 and 10 repetitions. In addition to the supervised treatment, participants will be requested to perform home exercises at home at least 3 days a week as 2 sets for a duration of 8 weeks, and an exercise diary will be provided. Prior to the treatment, the importance and content of the exercises will be thoroughly explained. | Other | Group A |
| Conventional physiotherapy plus home exercise programmeAlso: traditional physiotherapy, classic physiotherapyBefore each treatment session, a hot pack (thermotherapy) will be applied to the knee, calf, and thigh muscles for 20 minutes, followed by therapeutic ultrasound administered to the periarticular knee region for 10 minutes in pulsed mode, with a frequency of 1.0 MHz, an intensity of <1 W/cm², and a total dose of <150 J/cm². Exercises and recommendations identical to those prescribed for the home exercise group will be explained to the patients, and they will be instructed to perform these exercises in addition to the treatment, for 8 weeks, at least 3 days per week, in 2 sets per session. An exercise diary will be provided to monitor adherence. Prior to treatment, participants will be informed about the importance and content of the exercise program. | Other | Group B |
| Home exercise programmeAlso: home-based exercise programmeBased on the guidelines published by the American College of Sports Medicine (ACSM), Osteoarthritis Research Society International (OARSI), American Academy of Orthopaedic Surgeons (AAOS), European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO), and the European Alliance of Associations for Rheumatology (EULAR), participants will be prescribed a total of 12 home-based exercises to be performed over 8 weeks, at least 3 days per week, in 2 sets per session, with the number of repetitions progressively increased . These exercises and recommendations will be categorized under the subheadings of aerobic exercise, muscle strengthening, flexibility, neuromotor performance, and patient education. To enhance exercise adherence and facilitate follow-up, participants will be provided with an exercise diary. The diary will include a 3-month calendar schedule, illustrations of the exercises, and coded numerical markers correspo | Other | Group C |
Primary outcome
Muscle Strength / Hand-held dinamometer - Lafayette Instrument®, Lafayette, IN
Time frame: 8 weeks
Lower extremity muscle strength will be evaluated using a hand-held dynamometer (Lafayette Instrument®, Lafayette, IN) via maximal voluntary isometric contraction (the "make" test) and recorded in kilograms/Newtons. The assessment will include the muscle strength of hip flexion, extension, abduction, adduction, external and internal rotation; knee flexion and extension; and ankle plantar/dorsi flexion. Participants will be given the command: 'Hold as strongly as possible without moving your leg.' For each movement, three measurements will be performed (5-second contraction, 30-second rest), and the average values of these measurements will be calculated.
Balance - Fullerton Advanced Balance Scale (FAB-T)
Time frame: 8 weeks
The scale evaluates both static and dynamic balance under altered sensory conditions (soft surface, firm surface, decreased or increased support base, and verbal commands). It is specifically designed to measure balance in high-functioning, active older adults. The scale consists of 10 items, each scored between 0 and 4. A total score of 25 or below indicates a high risk of falling.
Pain Severity - The Numerical Rating Scale (NRS)
Time frame: 8 weeks
Pain severity over the past 24 hours (at its worst, at its best, and at rest) will be assessed via the Numeric Rating Scale (NRS) on a scale of 0 to 10, where 0 represents 'no pain' and 10 represents 'the worst imaginable pain.
Active Joint Position Sense (AJPS)
Time frame: 8 weeks
AJPS will be evaluated via photo-analysis using MATLAB and an iPhone 13 (50 cm distance, tripod, laser alignment). Anatomical markers (2x2 cm kinesio-tape) will be placed on the greater trochanter, lateral knee joint line, superior patella, fibular neck, and lateral malleolus. Participants in the supine position, with hips neutral and eyes masked, will actively reproduce target knee flexion angles (40°, 60°, 90°). Reference and reproduced positions will be photographed; the angular difference will be recorded as the error angle. After practice trials, measurements will be captured during a 4-second static phase. Three trials per angle will be performed in randomized order with 10-second intervals, and averages will be calculated. To prevent fatigue and angular memory bias, 1-minute rest periods will be provided. All measurements will be standardized by an experienced physiotherapist.
Knee Function (KOOS)
Time frame: 8 weeks
Knee Injury and Osteoarthritis Outcome Score (KOOS): Developed to assess knee injury and OA symptoms. It includes 42 items in 5 subscales: Pain, Symptoms, ADL, Sport/Rec, and QoL. Items are scored on a 0-4 Likert scale based on the past week. Each subscale is normalized to a 0-100 range.
Physical Mobility - TUG Test
Time frame: 8 weeks
Timed Up and Go (TUG) Test: TUG assesses independent mobility and functional ability. Participants rise from a chair, walk 3 meters at a safe pace, turn, walk back, and sit down. The duration is recorded in seconds. Results are interpreted as follows: ≤10 seconds indicates good balance and gait speed; 10-20 seconds indicates independence in outdoor mobility without aids; ≥20 seconds signifies impaired mobility, poor balance, and increased fall risk. The test provides a reliable measure of dynamic balance and functional performance in clinical populations. All procedures will be timed using a digital stopwatch and recorded.
Pressure Pain Threshold (PPT)/ (JTECH Medical-Algometer Commander, USA)
Time frame: 8 weeks
Measurements will be performed while the participant is in the supine and prone positions using a pressure algometer. In the supine position, measurements will be taken from the distal 1/3 of the iliopsoas muscle, the proximal and distal (suprapatellar) portions of the rectus femoris muscle, the infrapatellar tendon, the medial and lateral fat pads, the distal 1/3 of the iliotibial band, the adductor tendons, and the medial retinaculum. In the prone position, measurements will be obtained from the sacroiliac joint, the muscle bellies of the gluteus medius and piriformis, the proximal 1/3 of the medial and lateral heads of the gastrocnemius, and the popliteus muscle belly. The probe of the algometer will be applied perpendicularly to the designated area, and the pressure will be increased gradually at a rate of 1 kg/s. The value at which the mechanical stimulus first transitions into a sensation of pain will be recorded. Three measurements will be taken at 30-second intervals.
The Pain Catastrophizing Scale (PCS)
Time frame: 8 weeks
Pain Catastrophizing Scale (PCS): A 13-item self-report tool used to measure exaggerated negative thoughts about actual or anticipated pain. It assesses three dimensions: Rumination (items 8-11), Magnification (items 6, 7, 13), and Helplessness (items 1-5, 12). Rumination reflects preoccupation with pain, helplessness denotes an inability to cope, and magnification represents an intensified perception of pain threat. Each item is rated on a 5-point Likert scale (0=not at all, 4=all the time). Total scores range from 0 to 52, where higher scores indicate greater catastrophizing. A total score of ≥30 is identified as the clinical cutoff point for significant pain catastrophizing. This scale is vital for evaluating the psychological impact of pain and its influence on recovery and movement-related fear in clinical research and rehabilitation settings.
Knee Function (LYSHOLM)
Time frame: 8 weeks
Lysholm Knee Scoring Scale: Revised in 1985, it assesses 8 domains: limp, support, locking, instability, pain, swelling, stair climbing, and squatting. Total score (0-100) is categorized as Excellent (95-100), Good (84-94), Fair (65-83), or Poor (0-64).
Knee Function (WOMAC)
Time frame: 8 weeks
Western Ontario \& McMaster Universities Osteoarthritis Index (WOMAC): A valid index for OA, recommended by OMERACT. It comprises 24 items across 3 sections: Pain (max 20), Stiffness (max 8), and Physical Function (max 68). Higher scores indicate increased pain, stiffness, and functional impairment. All scales will be administered by a physiotherapist to evaluate functional status and quality of life.
8 secondary outcomes
Quality of Life / (World Health Organization Quality of Life Scale - Brief Form (WHOQOL-BREF)
Time frame: 8 weeks
Kinesiophobia - Tampa Scale for Kinesiophobia (TSK)
Time frame: 8 weeks
Aerobic and Physical Performance (Stair Climb Test)
Time frame: 8 weeks
Edema Assesment (Tape Measure)
Time frame: 8 weeks
Range of Motion (ROM) - (Universal Goniometer)
Time frame: 8 weeks
Fatique / Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Time frame: 8 weeks
World Health Organization Quality of Life - Older Adults Module (WHOQOL-OLD)
Time frame: 8 weeks
Aerobic and Physical Performance (6-Minute Walk Test (6MWT))
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
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- Background: PubMed 20204903Eser S, Saatli G, Eser E, Baydur H, Fidaner C. [The reliability and validity of the Turkish Version of the World Health Organization Quality of Life Instrument-Older Adults Module (WHOQOL-Old)]. Turk Psikiyatri Derg. 2010 Spring;21(1):37-48. Turkish.
- Background: PubMed 16328900Power M, Quinn K, Schmidt S; WHOQOL-OLD Group. Development of the WHOQOL-old module. Qual Life Res. 2005 Dec;14(10):2197-214. doi: 10.1007/s11136-005-7380-9.
- Background: PubMed 9626712Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667.
- Background: PubMed 24234727Vlaeyen JW, Kole-Snijders AM, Rotteveel AM, Ruesink R, Heuts PH. The role of fear of movement/(re)injury in pain disability. J Occup Rehabil. 1995 Dec;5(4):235-52. doi: 10.1007/BF02109988.
- Background: PubMed 15639634Tuzun EH, Eker L, Aytar A, Daskapan A, Bayramoglu M. Acceptability, reliability, validity and responsiveness of the Turkish version of WOMAC osteoarthritis index. Osteoarthritis Cartilage. 2005 Jan;13(1):28-33. doi: 10.1016/j.joca.2004.10.010.
- Background: PubMed 3068365Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.
- Background: PubMed 23666590Celik D, Coskunsu D, Kilicoglu O. Translation and cultural adaptation of the Turkish Lysholm knee scale: ease of use, validity, and reliability. Clin Orthop Relat Res. 2013 Aug;471(8):2602-10. doi: 10.1007/s11999-013-3046-z. Epub 2013 May 11.
- Background: PubMed 6896798Lysholm J, Gillquist J. Evaluation of knee ligament surgery results with special emphasis on use of a scoring scale. Am J Sports Med. 1982 May-Jun;10(3):150-4. doi: 10.1177/036354658201000306.
- Background: PubMed 23948834Gul ED, Yilmaz O, Bodur H. Reliability and validity of the Turkish version of the knee injury and osteoarthritis outcome score-physical function short-form (KOOS-PS). J Back Musculoskelet Rehabil. 2013;26(4):461-6. doi: 10.3233/BMR-130406.
- Background: PubMed 9699158Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug;28(2):88-96. doi: 10.2519/jospt.1998.28.2.88.
- Background: PubMed 28528981Darnall BD, Sturgeon JA, Cook KF, Taub CJ, Roy A, Burns JW, Sullivan M, Mackey SC. Development and Validation of a Daily Pain Catastrophizing Scale. J Pain. 2017 Sep;18(9):1139-1149. doi: 10.1016/j.jpain.2017.05.003. Epub 2017 May 19.
- American Academy of Orthopaedic Surgeons Management of Osteoarthritis of the Knee (Non-Arthroplasty) Evidence-Based Clinical Practice GuidelineLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual patient-level data are not publicly available due to privacy and confidentiality considerations. Individual participant data were not shared because they contain confidential and potentially identifiable information, and data sharing was not covered by the informed consent obtained from participants. Therefore, access to these data is restricted in accordance with ethical standards and data protection regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BBAT plus home exercise programme, Conventional physiotherapy plus home exercise programme and Home exercise programme in people with Knee Osteoarthritis, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Strength / Hand-held dinamometer - Lafayette Instrument®, Lafayette, IN (time frame: 8 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07395427, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.