Neuroplasticity After Proprioceptive Rehabiliation (NCT05277519) | Clinical Trial Compass
RecruitingNot Applicable
Neuroplasticity After Proprioceptive Rehabiliation
France56 participantsStarted 2022-06-16
Plain-language summary
Sequences of muscle tendon vibrations allow to reproduce the sensory feedback during movement like locomotion and kinaesthesia. It is known that such a treatment promotes motor recovery after stroke assuming that it enhances neuroplasticity. The aim of the research is to study the activity in cerebrospinal circuitry to evaluate the neuroplastic changes during and after instrumented proprioceptive rehabilitation relying on sequences of muscle vibration in subacute stroke stages.
Who can participate
Age range
18 Years – 70 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:
* hemiparesis at least transient in lower limb following an acquired brain injury (stroke or traumatic brain injury)
* French spoken
* Affiliated to a French social insurance
* No previous traumatic, vascular or neurodegenerative injuries
* Having presented during the acute phase or presenting a motor deficit of one of the lower limbs
* Presenting an absence of autonomy of walking at the entrance of the rehabilitation department
* In the sub-acute phase, i.e. from 15 days to 6 months after the accident
* Presenting moderate cognitive disorders allowing them to understand instructions and give their consent
Exclusion Criteria:
* strong cognitive disorders
* maintenance of justice, tutelage, legal guardianship
* Pregnancy and breastfeeding
* Outpatients who do not have weekly follow-up in the rehabilitation department
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
Baseline EMG
Timeframe: Evaluation at baseline (4 days before treatment)
2
Baseline EEG
Timeframe: Evaluation at baseline (4 days before treatment)
3
EMG change from baseline after 2-week treatment
Timeframe: Evaluation during the 3rd week of treatment
4
EEG change from baseline after 2-week treatment
Timeframe: Evaluation during the 3rd week of treatment
5
EMG change after the 5-week treatment
Timeframe: Evaluation 4 days after the end of the 5-week treatment
6
EEG change after the 5-week treatment
Timeframe: Evaluation 4 days after the end of the 5-week treatment
Trial details
NCT IDNCT05277519
SponsorInstitut National de la Santé Et de la Recherche Médicale, France