Effect of Luna EMG Robotic Therapy on Physiotherapy Outcomes in Post-Ischemic Stroke Patients (NCT07280884) | Clinical Trial Compass
CompletedNot Applicable
Effect of Luna EMG Robotic Therapy on Physiotherapy Outcomes in Post-Ischemic Stroke Patients
Poland62 participantsStarted 2022-05-01
Plain-language summary
The study evaluates the effectiveness of the Luna EMG robotic system in the rehabilitation of patients after ischemic stroke. The main objective is to assess the impact of robotic-assisted training on gait speed, balance, and bioelectrical activity of the thigh muscles (rectus femoris and biceps femoris). The study also analyzes whether the side of hemiparesis (left vs. right) influences the outcomes of physiotherapy. Participants are randomly assigned to either an experimental group receiving robotic therapy combined with standard rehabilitation or a control group receiving standard rehabilitation alone.
Who can participate
Age range
65 Years – 86 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of primary ischemic stroke
* Time from stroke: 4 to 15 weeks
* Age between 65 and 86 years
* Limited or impaired lower limb function
* Ability to walk 10 meters independently or with orthopedic assistance
* Muscle strength of at least -3 on the modified Medical Research Council (MRC) scale
* Cognitive function sufficient to understand instructions and participate in the study
* Stable clinical status
* Provided written informed consent
Exclusion Criteria:
* Hemorrhagic stroke or stroke in the posterior cerebral circulation
* Lower limb spasticity greater than 1+ on the modified Ashworth Scale (MAS)
* Functional limitations preventing the completion of selected tests
* Recent orthopedic injuries affecting balance
* Prior lower limb surgery
* Sensory aphasia
* Coexisting neurological disorders (e.g., Parkinson's disease, Huntington's disease)
* Lack of patient cooperation or refusal to consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Static and Dynamic Balance (Berg Balance Scale - BBS)
Timeframe: Baseline and at 4 weeks (post-intervention)
2
Change in Functional Mobility and Balance (Timed Up and Go Test - TUG)
Timeframe: Baseline and at 4 weeks (post-intervention)
3
Change in Trunk Control (Trunk Impairment Scale - TIS)
Timeframe: Baseline and at 4 weeks (post-intervention)
4
Change in Postural Control (Postural Assessment Scale for Stroke Patients - PASS)
Timeframe: Baseline and at 4 weeks (post-intervention)
5
Change in Gait Speed (10-Meter Walk Test - 10MWT)
Timeframe: Baseline and at 4 weeks (post-intervention)
Trial details
NCT IDNCT07280884
SponsorUniversity School of Physical Education, Krakow, Poland