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

Official title

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

Overview

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

• Other Quadriceps 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.
• Device robot -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.

Primary outcome measures

• Timed Up and Go Test (TUG) [Time frame: Baseline, 6 weeks, and 14 weeks]

Secondary outcome measures (3)

• Berg Balance Scale [Time frame: Baseline, 6 weeks, and 14 weeks]
• Quadriceps Muscle Thickness [Time frame: Baseline, 6 weeks, and 14 weeks]
• Quadriceps Cross-Sectional Area [Time frame: Baseline, 6 weeks, and 14 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Kanuni Sultan Suleyman Training and Research Hospital, Istanbul, Turkey — Küçükçekmece

Identifiers

NCT: NCT07589296 · KSS-TRH-PD-ROBO-NMES-2026

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗