跳至主要内容
临床试验/NCT07395427
NCT07395427Enrolling By Invitation不适用

Comparison of the Effects of Basic Body Awareness Therapy to Conventional Physiotherapy and Home Exercise Program in Individuals With Knee Osteoarthritis

Hacettepe University1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2025年12月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
63
试验地点
1
主要终点
Muscle Strength / Hand-held dinamometer - Lafayette Instrument®, Lafayette, IN

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
40 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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.

研究组 & 干预措施

Group B

Active Comparator

Conventional physiotherapy plus home exercise programme

干预措施: Conventional physiotherapy plus home exercise programme (Other)

Group C

Active Comparator

Home exercise programme

干预措施: Home exercise programme (Other)

Group A

Active Comparator

BBAT plus home exercise programme

干预措施: BBAT plus home exercise programme (Other)

结局指标

主要结局

Muscle Strength / Hand-held dinamometer - Lafayette Instrument®, Lafayette, IN

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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.

次要结局

  • 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)
  • Fatique / Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)(8 weeks)
  • World Health Organization Quality of Life - Older Adults Module (WHOQOL-OLD)(8 weeks)
  • Aerobic and Physical Performance (6-Minute Walk Test (6MWT))(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emine Esra DİKMEN

Msc Physiotherapist

Hacettepe University

研究点 (1)

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