Parkinson Disease (PD)
Conditions
Keywords
Parkinson disease, Robot-assisted gait training, Neuromuscular electrical stimulation, Quadriceps muscle, Rehabilitation, Balance, Gait, Ultrasonography
Brief 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.
Detailed description
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.
Interventions
OTHERQuadriceps Neuromuscular Electrical Stimulation (NMES)
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.
DEVICErobot -assisted gait training
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.
Sponsors
Kanuni Sultan Suleyman Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Timed Up and Go Test (TUG) | Baseline, 6 weeks, and 14 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Berg Balance Scale | Baseline, 6 weeks, and 14 weeks | Evaluation of balance performance using the Berg Balance Scale (0-56 points; higher scores indicate better balance performance) in patients with Parkinson's disease. |
| Quadriceps Muscle Thickness | Baseline, 6 weeks, and 14 weeks | Ultrasound-based assessment of quadriceps muscle thickness (mm) in patients with Parkinson disease. |
| Quadriceps Cross-Sectional Area | Baseline, 6 weeks, and 14 weeks | Ultrasound-based assessment of quadriceps cross-sectional area (cm²) in patients with Parkinson disease. |
Countries
Turkey (Türkiye)
Contacts
CONTACTdilek Ün Oğuzhanasiltürk, MD
Outcome results
None listed