Robot-Assisted Gait Training vs NMES in Parkinson's Disease
NCT07589296
Summary
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.
Eligibility
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
Conditions2
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NCT07589296