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

NCT07589296 | Recruiting

• 1 other identifier: KSS-TRH-PD-ROBO-NMES-2026
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease (PD)

Keywords

Parkinson disease; Robot-assisted gait training; Neuromuscular electrical stimulation; Quadriceps muscle; Rehabilitation; Balance; Gait; Ultrasonography

Outcome Measures

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.

  Baseline, 6 weeks, and 14 weeks

Secondary Outcomes (3)

• Berg Balance Scale

  Baseline, 6 weeks, and 14 weeks

• Quadriceps Muscle Thickness

  Baseline, 6 weeks, and 14 weeks

• Quadriceps Cross-Sectional Area

  Baseline, 6 weeks, and 14 weeks

Study Arms (2)

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.

Device: robot -assisted gait training

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.

Other: Quadriceps Neuromuscular Electrical Stimulation (NMES)

Interventions

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.

Quadriceps NMES Group

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.

Robot-Assisted Gait Training Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital, Istanbul, Turkey

Küçükçekmece, Istanbul, 34303, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

dilek Ün Oğuzhanasiltürk, MD

CONTACT

+90 5056367184; dilekunoguzhan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in Physical Medicine and Rehabilitation

Model Details: 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

Study Record Dates

• First Submitted: May 3, 2026
• First Posted: May 15, 2026
• Study Start: April 15, 2026
• Primary Completion: April 15, 2026
• Study Completion (Estimated): June 15, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

TU (1)