Parkinson Disease (PD)ROBO-NMES-PDNCT07589296
Robot-Assisted Gait Training vs NMES in Parkinson's Disease
A study testing Quadriceps Neuromuscular Electrical Stimulation (NMES) and robot -assisted gait training in people with Parkinson Disease (PD), run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease (PD)
- What is being tested?
- Quadriceps Neuromuscular Electrical Stimulation (NMES) and robot -assisted gait training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2026to 15 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kanuni Sultan Suleyman Training and Research Hospital, Istanbul, Turkey
Küçükçekmece, Istanbul, 34303
Dilek Ün Oğuzhanasiltürk, MD, +905056367184, dilekunoguzhan@gmail.com
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Parkinson Disease (PD)
- Being tested
- Quadriceps Neuromuscular Electrical Stimulation (NMES), robot -assisted gait training
- Keywords
- Parkinson disease, Robot-assisted gait training, Neuromuscular electrical stimulation, Quadriceps muscle, Rehabilitation, Balance, Gait, Ultrasonography
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 trainingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Quadriceps Neuromuscular Electrical Stimulation (NMES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 weeks, and 14 weeks
Secondary outcomes (3)
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.
Measured: Baseline, 6 weeks, and 14 weeks
Quadriceps Muscle Thickness
Ultrasound-based assessment of quadriceps muscle thickness (mm) in patients with Parkinson disease.
Measured: Baseline, 6 weeks, and 14 weeks
Quadriceps Cross-Sectional Area
Ultrasound-based assessment of quadriceps cross-sectional area (cm²) in patients with Parkinson disease.
Measured: Baseline, 6 weeks, and 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start15 Apr 2026
- Primary completion15 Apr 2026
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek ün oguzhanasilturk, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589296
- Sponsor's protocol ID
- KSS-TRH-PD-ROBO-NMES-2026
- Acronym
- ROBO-NMES-PD
- Status last verified
- May 2026
- First submitted
- 3 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07589296
- Acronym / sponsor ID
- ROBO-NMES-PD / KSS-TRH-PD-ROBO-NMES-2026
- Conditions
- Parkinson Disease (PD)
- Keywords
- Parkinson disease, Robot-assisted gait training, Neuromuscular electrical stimulation, Quadriceps muscle, Rehabilitation, Balance, Gait, Ultrasonography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Robot-Assisted Gait Training Group | Active comparator | Device: robot -assisted gait trainingParticipants 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. |
| Quadriceps NMES Group | Active comparator | Other: Quadriceps Neuromuscular Electrical Stimulation (NMES)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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Quadriceps NMES Group |
| robot -assisted gait trainingRobot-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. | Device | Robot-Assisted Gait Training Group |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quadriceps Neuromuscular Electrical Stimulation (NMES) and robot -assisted gait training in people with Parkinson Disease (PD), run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact dilek Ün Oğuzhanasiltürk, MD (+90 5056367184, dilekunoguzhan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go Test (TUG) (time frame: Baseline, 6 weeks, and 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.