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NCT Number: NCT07589296

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

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kanuni Sultan Suleyman Training and Research Hospital, Istanbul, Turkey

Küçükçekmece, Istanbul, 34303, Turkey (Türkiye)

Location status: Recruiting

Location contact

Dilek Ün Oğuzhanasiltürk, MD

CONTACT

[email protected]

+905056367184

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Quadriceps Muscle Thickness

    Time frame: Baseline, 6 weeks, and 14 weeks

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

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

dilek Ün Oğuzhanasiltürk, MD

CONTACT

[email protected]

+90 5056367184

Sponsors and collaborators

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Other

Registry information

Official study 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

Acronym: ROBO-NMES-PD

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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