"Comparison of Therapist-Led and Robot-Assisted Arm Therapy in Subacute Stroke Rehabilitation" (NCT07002463) | Clinical Trial Compass
CompletedNot Applicable
"Comparison of Therapist-Led and Robot-Assisted Arm Therapy in Subacute Stroke Rehabilitation"
Poland58 participantsStarted 2023-04-03
Plain-language summary
This study aims to compare the outcomes of upper limb motor therapy conducted by a physiotherapist with robot-assisted therapy using the Luna EMG device in patients in the subacute phase after stroke. Additionally, the study will examine the correlation between changes in muscle tone and motor function improvement. The randomized controlled trial will be conducted at the Rehabilitation Department of the T. Marciniak Lower Silesian Specialist Hospital in Wrocław, Poland. Two groups (robot-assisted vs. conventional therapy) will perform identical sets of movements with matched repetition counts over a 6-week therapy period. Functional improvement will be assessed using Fugl-Meyer Upper Extremity Assessment (FMA-UE), Box and Block Test (B\&BT), EQ-5D-5L, and MyotonPro measurements.
Who can participate
Age range
18 Years – 90 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:
* Age 18-90
* First-ever ischemic or hemorrhagic stroke within 6 weeks prior to enrollment
* Stable medical condition
* Fugl-Meyer Assessment for Upper Extremity (FMA-UE) ≤ 94
* Mini-Mental State Examination (MMSE) ≥ 23
* Signed informed consent
Exclusion Criteria:
* Fixed contractures in upper limb
* MAS ≥ 3 in any upper limb muscle
* Severe vision/hearing problems
* Severe dysphagia or respiratory issues
* Myasthenia or myasthenic syndrome
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.
1This trial compared therapist-led arm therapy with robot-assisted therapy for people recovering from stroke — since it's already completed, has any data been published yet, and what did it find about which approach helped upper arm movement more?
2The trial measured improvement using something called the Fugl-Meyer Upper Extremity score — can you explain what that scale measures and whether the results showed a meaningful real-world difference in arm function for patients like me?
3Since this study focused on the subacute stage of stroke recovery, which is the window I may be in right now, does the timing of when I start arm therapy matter, and would either of these approaches still be relevant for my situation?
4Robot-assisted therapy was one of the treatments studied here — is that kind of technology available at our facility, and based on this trial's findings, would it be worth pursuing compared to standard therapist-led sessions?
5My recovery involves hemiparesis and possible muscle spasticity, which were the exact conditions this trial looked at — based on what's been learned from studies like this one, what arm therapy approach would you recommend for someone at my stage?
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 Fugl-Meyer Assessment for Upper Extremity (FMA-UE) motor score (0-66)
Timeframe: Baseline, Week 3, Week 6, and 3 weeks after therapy completion
Trial details
NCT IDNCT07002463
SponsorWroclaw University of Health and Sport Sciences