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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Dilek Ün Oğuzhanasiltürk, MD
- Numéro de téléphone: +90 5056367184
- E-mail: dilekunoguzhan@gmail.com
Lieux d'étude
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Istanbul
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Küçükçekmece, Istanbul, Turquie (Türkiye), 34303
- Recrutement
- Kanuni Sultan Suleyman Training and Research Hospital, Istanbul, Turkey
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Contact:
- Dilek Ün Oğuzhanasiltürk, MD
- Numéro de téléphone: +905056367184
- E-mail: dilekunoguzhan@gmail.com
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: 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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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Timed Up and Go Test (TUG)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Berg Balance Scale
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- KSS-TRH-PD-ROBO-NMES-2026
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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