Robot-Assisted Gait Training vs NMES in Parkinson's Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorKanuni Sultan Suleyman Training and Research Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Quadriceps Neuromuscular Electrical Stimulation (NMES)

    Other intervention

    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.

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Robot-Assisted Gait Training GroupActive comparator 1 intervention
Group B: Quadriceps NMES GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 6 weeks, and 14 weeks

Secondary outcomes

1

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.

Time frame
Baseline, 6 weeks, and 14 weeks
2

Quadriceps Muscle Thickness

Ultrasound-based assessment of quadriceps muscle thickness (mm) in patients with Parkinson disease.

Time frame
Baseline, 6 weeks, and 14 weeks
3

Quadriceps Cross-Sectional Area

Ultrasound-based assessment of quadriceps cross-sectional area (cm²) in patients with Parkinson disease.

Time frame
Baseline, 6 weeks, and 14 weeks

Other outcomes

Sponsors and contacts

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