Comparison of the Effects of Basic Body Awareness Therapy in Individuals With Knee Osteoarthritis

NCT07395427 | Enrolling By Invitation DMC

• 1 other identifier: HU-FTR-EED-01
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritis; mind-body therapy; exercise; proprioception; physiotherapy

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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).

  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.

  8 weeks

Secondary Outcomes (8)

• Quality of Life / (World Health Organization Quality of Life Scale - Brief Form (WHOQOL-BREF)

  8 weeks

• Kinesiophobia - Tampa Scale for Kinesiophobia (TSK)

  8 weeks

• Aerobic and Physical Performance (Stair Climb Test)

  8 weeks

• Edema Assesment (Tape Measure)

  8 weeks

• Range of Motion (ROM) - (Universal Goniometer)

  8 weeks

Study Arms (3)

Group A

ACTIVE COMPARATOR

BBAT plus home exercise programme

Other: BBAT plus home exercise programme

Group B

ACTIVE COMPARATOR

Conventional physiotherapy plus home exercise programme

Other: Conventional physiotherapy plus home exercise programme

Group C

ACTIVE COMPARATOR

Home exercise programme

Other: Home exercise programme

Interventions

Home exercise programme OTHER

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

Also known as: home-based exercise programme

Group C

BBAT plus home exercise programme OTHER

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.

Group A

Conventional physiotherapy plus home exercise programme OTHER

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.

Also known as: traditional physiotherapy, classic physiotherapy

Group B

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University/Faculty of Physical Therapy and Rehabilitation/ Orthopedic Rehabilitation Unit

Ankara, Ankara, 06050, Turkey (Türkiye)

Location

Related Publications (20)

• 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.

  PMID: 24561411 BACKGROUND

• Eser 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.

  PMID: 20204903 BACKGROUND

• Power 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.

  PMID: 16328900 BACKGROUND

• Development 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.

  PMID: 9626712 BACKGROUND

• Vlaeyen 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.

  PMID: 24234727 BACKGROUND

• Tuzun 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.

  PMID: 15639634 BACKGROUND

• Bellamy 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.

  PMID: 3068365 BACKGROUND

• Celik 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.

  PMID: 23666590 BACKGROUND

• Lysholm 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.

  PMID: 6896798 BACKGROUND

• Gul 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.

  PMID: 23948834 BACKGROUND

• Roos 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.

  PMID: 9699158 BACKGROUND

• Darnall 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.

  PMID: 28528981 BACKGROUND

• Arden 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.

  PMID: 33116279 BACKGROUND

• Skou 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.

  PMID: 31621559 BACKGROUND

• Kolasinski 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.

  PMID: 31908149 BACKGROUND

• McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, Hawker GA, Henrotin Y, Hunter DJ, Kawaguchi H, Kwoh K, Lohmander S, Rannou F, Roos EM, Underwood M. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014 Mar;22(3):363-88. doi: 10.1016/j.joca.2014.01.003. Epub 2014 Jan 24.

  PMID: 24462672 BACKGROUND

• Fernandes L, Hagen KB, Bijlsma JW, Andreassen O, Christensen P, Conaghan PG, Doherty M, Geenen R, Hammond A, Kjeken I, Lohmander LS, Lund H, Mallen CD, Nava T, Oliver S, Pavelka K, Pitsillidou I, da Silva JA, de la Torre J, Zanoli G, Vliet Vlieland TP; European League Against Rheumatism (EULAR). EULAR recommendations for the non-pharmacological core management of hip and knee osteoarthritis. Ann Rheum Dis. 2013 Jul;72(7):1125-35. doi: 10.1136/annrheumdis-2012-202745. Epub 2013 Apr 17.

  PMID: 23595142 BACKGROUND

• Sale JE, Gignac M, Hawker G. The relationship between disease symptoms, life events, coping and treatment, and depression among older adults with osteoarthritis. J Rheumatol. 2008 Feb;35(2):335-42. Epub 2008 Jan 15.

  PMID: 18203312 BACKGROUND

• Lluch E, Nijs J, Courtney CA, Rebbeck T, Wylde V, Baert I, Wideman TH, Howells N, Skou ST. Clinical descriptors for the recognition of central sensitization pain in patients with knee osteoarthritis. Disabil Rehabil. 2018 Nov;40(23):2836-2845. doi: 10.1080/09638288.2017.1358770. Epub 2017 Aug 2.

  PMID: 28768437 BACKGROUND

• Skjaerven LH, Mattsson M, Catalan-Matamoros D, Parker A, Gard G, Gyllensten AL. Consensus on core phenomena and statements describing Basic Body Awareness Therapy within the movement awareness domain in physiotherapy. Physiother Theory Pract. 2019 Jan;35(1):80-93. doi: 10.1080/09593985.2018.1434578. Epub 2018 Feb 26.

  PMID: 29482403 BACKGROUND

Related Links

• American Academy of Orthopaedic Surgeons Management of Osteoarthritis of the Knee (Non-Arthroplasty) Evidence-Based Clinical Practice Guideline

MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Msc Physiotherapist

Model Details: Randomised Control Clinical Trial

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: February 9, 2026
• Study Start: December 8, 2025
• Primary Completion: December 8, 2025
• Study Completion (Estimated): July 30, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)