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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：dilek Ün Oğuzhanasiltürk, MD
- 電話番号：+90 5056367184
- メール：dilekunoguzhan@gmail.com
研究場所
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Istanbul
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Küçükçekmece、Istanbul、トルコ（Türkiye）、34303
- 募集
- Kanuni Sultan Suleyman Training and Research Hospital, Istanbul, Turkey
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コンタクト：
- Dilek Ün Oğuzhanasiltürk, MD
- 電話番号：+905056367184
- メール：dilekunoguzhan@gmail.com
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Timed Up and Go Test (TUG)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Berg Balance Scale
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- KSS-TRH-PD-ROBO-NMES-2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
パーキンソン病 (PD)の臨床試験
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Oxford Biodynamics Inc.Community Clinical Oncology Research Network, LLC募集癌 | 免疫療法 | PD-L1 | PD-1 | 免疫チェックポイント療法アメリカ
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Samsung Medical Centerわからない
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EicOsis Human Health Inc.University of California, Davis; Michael J. Fox Foundation for Parkinson's Research募集
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Aida Frías GonzálezSpanish Society of Nephrology; SOMANE (MADRID SOCIETY OF NEPHROLOGY); Foundation for Biomedical...募集
-
Jiangsu vcare pharmaceutical technology co., LTD完了
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Agenus Inc.完了進行性固形がん | PD-1およびPD-L1療法に耐抵抗性の高度な固体がんアメリカ
robot -assisted gait trainingの臨床試験
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First Affiliated Hospital of Fujian Medical University積極的、募集していない