Robot-Assisted Gait Training vs NMES in Parkinson's Disease (ROBO-NMES-PD)
Comparative Effects of Robot-Assisted Gait Training and Quadriceps Neuromuscular Electrical Stimulation Added to Standard Exercise Rehabilitation on Balance, Gait, Disease Severity, and Quadriceps Muscle Adaptations in Patients With Parkinson Disease: A Prospective Randomized Assessor-Blinded Clinical Trial
This prospective, randomized, assessor-blinded clinical trial aims to compare the effects of robot-assisted gait training and quadriceps neuromuscular electrical stimulation (NMES) when added to a standard exercise rehabilitation program in patients with Parkinson disease.
Participants will be randomly assigned to two parallel groups. Both groups will receive a standard rehabilitation program, while one group will additionally undergo robot-assisted gait training and the other group will receive quadriceps NMES. The interventions will be administered five days per week for six weeks.
Clinical outcomes, including balance, functional mobility, gait performance, and disease severity, will be evaluated at baseline, post-treatment, and follow-up (week 14). In addition, ultrasound-based assessments of quadriceps muscle thickness and cross-sectional area will be performed to investigate muscle adaptations.
The results of this study are expected to provide comparative evidence regarding the effectiveness of these two rehabilitation approaches and contribute to optimizing rehabilitation strategies in Parkinson disease.
연구 개요
상태
정황
상세 설명
This is a single-center, prospective, randomized, assessor-blinded clinical trial. The study will include patients with idiopathic Parkinson's disease who meet the eligibility criteria. After baseline assessment and written informed consent, participants will be randomly assigned to one of two parallel intervention groups.
All participants will receive a standard Parkinson rehabilitation program including posture exercises, balance and coordination training, stretching and relaxation exercises, functional gait training, and lower extremity strengthening exercises. In addition to this standard program, one group will receive robot-assisted gait training and the other group will receive neuromuscular electrical stimulation applied to the quadriceps muscle.
The intervention period will last six weeks, with treatment sessions performed five days per week. Participants will be evaluated at baseline, at the end of the six-week treatment period, and at follow-up in week 14. Clinical assessments will be performed by an assessor blinded to group allocation. Ultrasonographic measurements of the quadriceps muscle will also be performed using a standardized technique.
The study is designed to compare the clinical and muscle-related effects of these two adjunctive rehabilitation approaches in Parkinson's disease.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: dilek Ün Oğuzhanasiltürk, MD
- 전화번호: +90 5056367184
- 이메일: dilekunoguzhan@gmail.com
연구 장소
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Istanbul
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Küçükçekmece, Istanbul, 터키 (Türkiye), 34303
- 모병
- Kanuni Sultan Suleyman Training and Research Hospital, Istanbul, Turkey
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연락하다:
- Dilek Ün Oğuzhanasiltürk, MD
- 전화번호: +905056367184
- 이메일: dilekunoguzhan@gmail.com
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-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Diagnosis of Parkinson's disease according to established clinical criteria
- Age between 40 and 80 years
- Hoehn and Yahr stage II-III
- Ability to walk independently with or without assistive devices
- Stable medical treatment for at least 4 weeks prior to study enrollment
- Ability to understand and follow instructions
- Willingness to participate and provide written informed consent
Exclusion Criteria:
- Severe cognitive impairment or inability to follow instructions
- Hoehn and Yahr stage IV-V Parkinson's disease
- Severe musculoskeletal disorders affecting gait (e.g., advanced osteoarthritis, recent fracture)
- History of lower extremity surgery within the last 6 months
- Severe cardiovascular or respiratory disease limiting exercise participation
- Presence of other neurological disorders affecting mobility (e.g., stroke, multiple sclerosis)
- Contraindications to electrical stimulation (e.g., pacemaker, implanted electronic devices)
- Skin lesions or infections at electrode placement sites
- Participation in another structured rehabilitation program within the last 3 months
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: Robot-Assisted Gait Training Group
Participants in this group will receive a standard rehabilitation program in addition to robot-assisted gait training.
The intervention will be applied five days per week for six weeks.
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Robot-assisted gait training applied in addition to a standard rehabilitation program including posture exercises, balance and coordination training, relaxation, and functional gait training in patients with Parkinson's disease.
This intervention is designed to improve gait performance, balance, and functional mobility.
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활성 비교기: Quadriceps NMES Group
Participants in this group will receive a standard rehabilitation program in addition to quadriceps neuromuscular electrical stimulation (NMES).
The intervention will be applied five days per week for six weeks.
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Quadriceps neuromuscular electrical stimulation (NMES) applied to the quadriceps muscle in addition to a standard rehabilitation program including posture exercises, balance and coordination training, relaxation, and functional gait training in patients with Parkinson's disease.
This intervention specifically targets improvement of quadriceps muscle strength and neuromuscular activation.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Timed Up and Go Test (TUG)
기간: Baseline, 6 weeks, and 14 weeks
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Assessment of functional mobility and balance using the Timed Up and Go test in patients with Parkinson's disease.
Lower completion times indicate better functional mobility.
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Baseline, 6 weeks, and 14 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Berg Balance Scale
기간: Baseline, 6 weeks, and 14 weeks
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Evaluation of balance performance using the Berg Balance Scale (0-56 points; higher scores indicate better balance performance) in patients with Parkinson's disease.
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Baseline, 6 weeks, and 14 weeks
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Quadriceps Muscle Thickness
기간: Baseline, 6 weeks, and 14 weeks
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Ultrasound-based assessment of quadriceps muscle thickness (mm) in patients with Parkinson disease.
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Baseline, 6 weeks, and 14 weeks
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Quadriceps Cross-Sectional Area
기간: Baseline, 6 weeks, and 14 weeks
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Ultrasound-based assessment of quadriceps cross-sectional area (cm²) in patients with Parkinson disease.
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Baseline, 6 weeks, and 14 weeks
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
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 연구와 관련된 용어
기타 연구 ID 번호
- KSS-TRH-PD-ROBO-NMES-2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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