Robot-Assisted Gait Training vs NMES in Parkinson's Disease (ROBO-NMES-PD)

May 11, 2026 updated by: Dilek ün oguzhanasilturk, Kanuni Sultan Suleyman Training and Research Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Istanbul
      • Küçükçekmece, Istanbul, Turkey (Türkiye), 34303
        • Recruiting
        • Kanuni Sultan Suleyman Training and Research Hospital, Istanbul, Turkey
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Robot-Assisted Gait Training Group
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
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.
Active Comparator: Quadriceps NMES Group
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed Up and Go Test (TUG)
Time Frame: 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.
Baseline, 6 weeks, and 14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Berg Balance Scale
Time Frame: 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.
Baseline, 6 weeks, and 14 weeks
Quadriceps Muscle Thickness
Time Frame: Baseline, 6 weeks, and 14 weeks
Ultrasound-based assessment of quadriceps muscle thickness (mm) in patients with Parkinson disease.
Baseline, 6 weeks, and 14 weeks
Quadriceps Cross-Sectional Area
Time Frame: Baseline, 6 weeks, and 14 weeks
Ultrasound-based assessment of quadriceps cross-sectional area (cm²) in patients with Parkinson disease.
Baseline, 6 weeks, and 14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2026

Primary Completion (Actual)

April 15, 2026

Study Completion (Estimated)

June 15, 2027

Study Registration Dates

First Submitted

May 3, 2026

First Submitted That Met QC Criteria

May 11, 2026

First Posted (Actual)

May 15, 2026

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSS-TRH-PD-ROBO-NMES-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson Disease (PD)

Clinical Trials on robot -assisted gait training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe