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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot-Assisted Gait Training Group | Active Comparator | 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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| Quadriceps NMES Group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadriceps Neuromuscular Electrical Stimulation (NMES) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Timed Up and Go Test (TUG) | 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. | Baseline, 6 weeks, and 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Berg Balance Scale | Evaluation of balance performance using the Berg Balance Scale (0-56 points; higher scores indicate better balance performance) in patients with Parkinson's disease. | Baseline, 6 weeks, and 14 weeks |
| Quadriceps Muscle Thickness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| dilek Ün Oğuzhanasiltürk, MD | Contact | +90 5056367184 | dilekunoguzhan@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kanuni Sultan Suleyman Training and Research Hospital, Istanbul, Turkey | Recruiting | Küçükçekmece | Istanbul | 34303 | Turkey (Türkiye) |
Individual participant data (IPD) will not be shared due to ethical and privacy considerations. The study involves sensitive clinical data, and participants have not provided consent for public data sharing.
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Participants will be randomly assigned to one of two parallel groups using a simple randomization method. Both groups will receive a standard rehabilitation program. In addition, one group will receive robot-assisted gait training, while the other group will receive quadriceps neuromuscular electrical stimulation (NMES). The interventions will be applied over a six-week period, and participants will be evaluated at baseline, post-treatment, and follow-up
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| robot -assisted gait training | Device | 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. |
|
Ultrasound-based assessment of quadriceps muscle thickness (mm) in patients with Parkinson disease.
| Baseline, 6 weeks, and 14 weeks |
| Quadriceps Cross-Sectional Area | Ultrasound-based assessment of quadriceps cross-sectional area (cm²) in patients with Parkinson disease. | Baseline, 6 weeks, and 14 weeks |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |