- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07575425
Effects of Mobilized Balance Platform Exercises on Balance Parameters in Patients With Knee Osteoarthritis
Effects of Mobilized Balance Platform Exercises on Balance Parameters, Functional Status, and Pain in Patients With Knee Osteoarthritis: A Randomized Controlled Trial
This prospective single-blind randomized controlled study aims to investigate the effects of mobilized balance platform exercises on balance parameters, pain, functional status, fear of falling, and kinesiophobia in patients with knee osteoarthritis. A total of 36 patients diagnosed with knee osteoarthritis will be recruited from the outpatient clinic of Gaziler Physical Medicine and Rehabilitation Training and Research Hospital.
Participants will be randomly assigned to one of two groups. The control group will receive conventional physical therapy including transcutaneous electrical nerve stimulation (TENS) and a home exercise program consisting of knee strengthening, balance, range of motion, proprioceptive, and stretching exercises. The intervention group will receive the same conventional treatment in addition to mobilized balance platform exercises using the Huber 360 system.
Pain severity, functional status, balance parameters, fear of falling, and kinesiophobia will be evaluated before and after treatment by an assessor blinded to treatment allocation.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Sefa Gumruk Aslan
- 전화번호: +903122911503
- 이메일: sefagumrukk@gmail.com
연구 장소
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Ankara, 터키 (Türkiye)
- 모병
- Gaziler physical therapy and rehabilitation
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연락하다:
- Sefa Gumruk Aslan
- 전화번호: +903122911503
- 이메일: sefagumrukk@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patients aged between 45 and 65 years
- Diagnosis of knee osteoarthritis classified as Kellgren-Lawrence grade 2 or 3
- Willingness to participate voluntarily in the study
Exclusion Criteria:
- Presence of orthopedic knee implants
- Kellgren-Lawrence grade 1 or grade 4 knee osteoarthritis
- Sensory impairment
- Diagnosis of malignancy
- Unhealed fractures
- Circulatory disorders
- Infection around the knee joint
- Severe hearing loss or visual impairment
- Cognitive impairment
- Uncontrolled hypertension or diabetes mellitus
- Vestibular disorders causing balance problems, such as vertigo
- Use of walking assistive devices such as canes or walkers
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Conventional Physical Therapy
Participants in this group will receive conventional physical therapy including transcutaneous electrical nerve stimulation (TENS) and a home exercise program.
The home exercise program will include knee strengthening, balance, range of motion, proprioceptive, and stretching exercises, performed 3 days per week for 20 minutes.
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Participants will receive conventional physical therapy including transcutaneous electrical nerve stimulation (TENS) and a home exercise program consisting of knee strengthening, balance, range of motion, proprioceptive, and stretching exercises performed 3 times per week for 20 minutes.
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실험적: Mobilized Balance Platform Exercise
Participants in this group will receive conventional physical therapy including TENS in addition to mobilized balance platform exercises using the Huber 360 system.
The exercise protocol will include quadriceps and core strengthening, proprioceptive, balance, and neuromuscular exercises, performed 3 days per week for 20 minutes.
|
Participants will receive conventional physical therapy including transcutaneous electrical nerve stimulation (TENS) and a home exercise program consisting of knee strengthening, balance, range of motion, proprioceptive, and stretching exercises performed 3 times per week for 20 minutes.
Participants will perform mobilized balance platform exercises using the Huber 360 system.
The exercise protocol will include quadriceps and core strengthening, proprioceptive training, balance exercises, and neuromuscular exercises specifically designed for patients with knee osteoarthritis.
Sessions will be performed 3 times per week for 20 minutes.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Static and Dynamic Balance Parameters
기간: Before treatment and immediately after completion of the 8-week treatment program
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Balance performance will be assessed using the Huber 360 balance assessment system.
Measurements will include static balance with eyes open and eyes closed, single-leg balance performance, and limits of stability.
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Before treatment and immediately after completion of the 8-week treatment program
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain Severity Assessed by Visual Analog Scale (VAS)
기간: Before treatment and immediately after completion of the 8-week treatment program
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Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS) for night pain, resting pain, and pain during movement.
Higher scores indicate greater pain severity.
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Before treatment and immediately after completion of the 8-week treatment program
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Functional Status Assessed by WOMAC
기간: Before treatment and immediately after completion of the 8-week treatment program
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Functional status will be evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Higher scores indicate worse pain, stiffness, and functional limitation.
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Before treatment and immediately after completion of the 8-week treatment program
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Functional Mobility Assessed by Timed Up and Go Test
기간: Before treatment and immediately after completion of the 8-week treatment program
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Functional mobility and dynamic balance will be assessed using the Timed Up and Go Test.
Shorter completion times indicate better functional mobility.
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Before treatment and immediately after completion of the 8-week treatment program
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Fear of Falling Assessed by the International Falls Efficacy Scale
기간: Before treatment and immediately after completion of the 8-week treatment program
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Fear of falling during activities of daily living will be evaluated using the International Falls Efficacy Scale.
Higher scores indicate greater concern about falling.
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Before treatment and immediately after completion of the 8-week treatment program
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Kinesiophobia Assessed by Tampa Scale for Kinesiophobia
기간: Before treatment and immediately after completion of the 8-week treatment program
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Fear of movement and reinjury will be evaluated using the Tampa Scale for Kinesiophobia.
Higher scores indicate greater fear of movement.
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Before treatment and immediately after completion of the 8-week treatment program
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공동 작업자 및 조사자
수사관
- 수석 연구원: Sefa Gümrük Aslan, gaziler physcial therapy and rehabilitation hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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