- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07701174
Weighted Dangling Exercises vs Vastus Medialis Oblique Muscle Neuromuscular Stimulation for Knee Osteoarthritis
2026년 7월 8일 업데이트: Mahnoor Fatima, University of Lahore
Effectiveness of Weighted Dangling Exercises Versus Vastus Medialis Oblique Muscle Neuromuscular Stimulation in Patients With Knee Osteoarthritis
This randomized controlled trial aims to compare the effectiveness Weighted dangling exercises versus vastus medialis oblique muscle neuromuscular electrical stimulation(VMO+NMES) in patients with knee osteoarthritis.
The study will recruit 48 participants (accounting for 10% attrition), aged 40-60 years, from University of Lahore Teaching Hospital using convenience sampling.
Participants will be randomly allocated into two groups: an interventional group receiving WDE and other interventional group undergoing VMO strength training with NMES.
Both interventions will be administered three times per week for 8 weeks under professional supervision.
Outcome measures including pain intensity (NPRS), Functional Disability (Western Ontario and McMaster Universities Osteoarthritis Index),Muscle Strength (MMT) will be assessed at baseline, 4 weeks, and 8 weeks.
Data will be analyzed using SPSS, with appropriate parametric or non-parametric tests applied after checking data normality.
Ethical approval will be obtained, informed consent will be secured, and participant confidentiality will be strictly maintained.
연구 개요
상세 설명
This study is a single-blinded randomized controlled trial designed to evaluate and compare the therapeutic effectiveness Weighted dangling exercises versus vastus medialis oblique muscle neuromuscular electrical stimulation(VMO+NMES) in patients with knee osteoarthritis.
The study will recruit 48 participants (accounting for 10% attrition), aged 40-60 years, from University of Lahore Teaching Hospital over a duration of 9 months following synopsis approval.
A total sample size of 48 participants (24 per group) has been determined using epitool software, based on theWestern Ontario and McMaster Universities Osteoarthritis Index) , with a confidence level of 95%, power of 80%, and a 10% attrition allowance.
Participants aged 40-60 years, of both genders, with clinically confirmed knee osteoarthritis.
Symptoms of unilateral knee pain and crepitus persist for at least 6 months during ascending and descending motion.
Radiographic Knee osteoarthritis examination.
Exclusion includes recent surgery (within three months) history of hip or knee joint replacement, tibial osteotomy, or those with systemic arthritis, history of trauma such as knee fracture and other with muscular disease of neurological disorders that would affect lower extremity function is excluded.
Eligible participants will be enrolled after providing written informed consent and randomized using a computer-generated block randomization method, with allocation concealment ensured through sealed opaque envelopes.
Outcome assessors will be blinded to group allocation to minimize assessment bias.
The one group will receive weighted dangling exercise.
A gravity-assisted flexion-extension movements of the lower legs Ankle cuffs weight worn during the exercise while seated on a high couch with their legs hanging down.
Other group receive neuromuscular electrical stimulation (NMES) specifically targeting the vastus medialis oblique (VMO).
The NMES parameters are as follows: electrodes were placed above the superomedial border of the patella, oriented at a 55° angle to the vertical.
The stimulation frequency set at 50 Hz, with a pulse duration of 250 µs and a duty cycle of 10 seconds ON and 30 seconds OFF.
Sessions will be conducted three times weekly for 8 weeks, totaling 24 supervised sessions.
Primary and secondary outcome measures include pain intensity (Numeric Pain Rating Scale),theWestern Ontario and McMaster Universities Osteoarthritis Index (WOMAC), muscle strength, assessed at baseline, 4 weeks, and 8 weeks post-intervention.
Data will be analyzed using SPSS (version 25/27).
Descriptive statistics will summarize participant characteristics, while inferential statistics will be applied based on data distribution, with significance determined accordingly.
Ethical considerations will strictly adhere to the guidelines of the Institutional Research Ethics Board (IREB), University of Lahore.
Participant confidentiality, voluntary participation, right to withdraw, and safety monitoring will be ensured throughout the study.
No serious adverse effects are anticipated.
연구 유형
중재적
등록 (추정된)
48
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Ishaq Ahmed, PhD PT
- 전화번호: 03344066463
- 이메일: ishaq.ahmed@uipt.uol.edu.pk
연구 연락처 백업
- 이름: Ashfaq Ahmed, PhD PT
- 전화번호: 03009449192
- 이메일: ashfaq.ahmed@uipt.uol.edu.pk
연구 장소
-
-
Punjab Province
-
Lahore, Punjab Province, 파키스탄, 54000
- 모병
- University of Lahore Teaching Hospital, Lahore, Pakistan
-
연락하다:
- Asim Arif, PhD PT*
- 전화번호: 03216597727
- 이메일: asim.arif@uipt.uol.edu.pk
-
연락하다:
- Mahnoor Fatima, MS MSK*
- 전화번호: 03164247896
- 이메일: 70174837@student.uol.edu.pk
-
수석 연구원:
- Mahnoor Fatima, MS MSK
-
수석 연구원:
- Hafiza Sana Ashraf, PhD PT*
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
Both genders and aged between 40 and 60 years. Symptoms of unilateral knee pain and crepitus persist for at least 6 months during ascending and descending motion. Radiographic KOA; grade 2 or more according to Kellgren and Lawrence scale. Patient referred by an orthopedic physician Those who have taken oral corticosteroids within the last month or who received intra-articular corticosteroid injection or analgesic injection intervention for hip or knee pain within the last 3 month
Exclusion Criteria:
- Recent surgery (within three months) history of hip or knee joint replacement, tibial osteotomy, orthoses with systemic arthritis, history of trauma such as knee fracture and other with muscular disease of neurological disorders that would affect lower extremity function is excluded.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: interventional group A
The experimental group A will receive weighted dangling exercise.
A gravity-assisted flexion-extension movements of the lower legs Ankle cuffs weight worn during the exercise while seated on a high couch with their legs hanging down
|
This group receive neuromuscular electrical stimulation (NMES) specifically targeting the vastus medialis oblique (VMO).
The NMES parameters are as follows: electrodes were placed above the superomedial border of the patella, oriented at a 55° angle to the vertical.
The stimulation frequency set at 50 Hz, with a pulse duration of 250 µs and a duty cycle of 10 seconds ON and 30 seconds OFF
|
|
활성 비교기: interventional group B
Experimental group B receive neuromuscular electrical stimulation (NMES) specifically targeting the vastus medialis oblique (VMO).
The NMES parameters are as follows: electrodes were placed above the superomedial border of the patella, oriented at a 55° angle to the vertical.
The stimulation frequency set at 50 Hz, with a pulse duration of 250 µs and a duty cycle of 10 seconds ON and 30 seconds OFF
|
The one group will receive weighted dangling exercise.
A gravity-assisted flexion-extension movements of the lower legs Ankle cuffs weight worn during the exercise while seated on a high couch with their legs hanging down
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pain Intensity (Numeric Pain Rating Scale)
기간: baseline,4 weeks and 8 weeks
|
Pain in this study is defined as subjective discomfort in the knee joint caused by osteoarthritis.
It was evaluated using the Numeric Pain Rating Scale (NPRS), which is a reliable and proven technique for quantifying pain intensity.
Participants score their discomfort on an 11-point scale, with 0 indicating "no pain" and 10 representing "the worst pain imaginable.
|
baseline,4 weeks and 8 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Functional disability:(WOMAC)
기간: Baseline 4 weeks and 8 weeks
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), which is a well-used and validated questionnaire.
The WOMAC measures three dimensions: pain (5 things), stiffness (2 items), and physical function (17 items).
Each item is assessed on a scale of 0 (no difficulty) to 4 (severe difficulty), with a total WOMAC score of 0-96.
Higher scores indicate greater functional disability.
The questionnaire examines pain while walking or ascending stairs, stiffness in the morning or later in the day, and difficulty with sitting, standing, and lifting objects.
|
Baseline 4 weeks and 8 weeks
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Mahnoor Fatima, MS MSK*, University Institute of Physical Therapy, University of Lahore
- 수석 연구원: Hafiza Sana Ashraf, PhD PT*, University Institute of Physical Therapy, University of Lahore
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 5월 25일
기본 완료 (추정된)
2026년 8월 25일
연구 완료 (추정된)
2026년 9월 10일
연구 등록 날짜
최초 제출
2026년 7월 8일
QC 기준을 충족하는 최초 제출
2026년 7월 8일
처음 게시됨 (실제)
2026년 7월 14일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 8일
마지막으로 확인됨
2026년 7월 1일
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. .