Using robotics to improve motor skills in patients with acute stroke
Exploring Motor Learning in Acute Stroke Through Robotics
NA · University Hospital of Mont-Godinne · NCT04171856
This study is testing if a rehabilitation robot can help people who have just had a stroke learn and keep complex motor skills better than healthy individuals and those who had a stroke a while ago.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 245 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University Hospital of Mont-Godinne (other) |
| Locations | 2 sites (Yvoir, Namur and 1 other locations) |
| Trial ID | NCT04171856 on ClinicalTrials.gov |
What this trial studies
This research program investigates the ability of acute stroke patients to learn and retain complex motor skills using a rehabilitation robot called REAplan®. Over three days, participants will engage in training through serious games designed to enhance motor skill learning. The study aims to compare the performance of acute stroke patients with healthy individuals and chronic stroke patients, while also examining how different brain regions affected by stroke impact motor skill learning. Participants will be randomized into different groups to assess the effectiveness of various rehabilitation approaches.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-90 who have experienced an acute stroke within the last 21 days and have a stroke lesion visible on brain imaging.
Not a fit: Patients with complete paralysis of the affected arm, severe cognitive deficits, or those with contraindications to MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved rehabilitation strategies that enhance motor recovery in acute stroke patients.
How similar studies have performed: While the specific approach of using robotics for motor skill learning in acute stroke patients is innovative, similar studies have shown promise in enhancing rehabilitation outcomes in stroke recovery.
Eligibility criteria
Show full inclusion / exclusion criteria
ACUTE STROKE PATIENTS: Inclusion Criteria: * acute stroke (\> 21 days) * aged 18-90 years * with a stroke lesion on brain imaging Exclusion Criteria: * " classical " contre-indication to MRI (non-MR-compatible pacemaker, pregnancy, non-MR-compatible implanted devices, claustrophoby, etc ...) * difficulty in understanding or executing commands * drug/alcohol abuse * severe aphasia / cognitive deficits interfering with study * inability to voluntarily move the affected arm (i.e. complete paralysis of the arm) * multiple strokes / dementia / psychiatric condition PATIENTS WITH TRANSIENT GLOBAL AMNESIA: Clinical diagnosis, criteria of Hodge \& Warlow (1990): * Anterograde amnesia observed by a witness * No alteration of consciousness or loss of identity * Cognitive dysfunction limited to amnesia * Lack of focused neurological deficit or argument for a comitiality * Absence of head trauma * Symptom resolution within 24 hours * Possible existence of vegetative symptoms Inclusion criteria: * Transient global amnesia * 8-90 years old * Be able to perform 3 consecutive sessions on a rehabilitation robot Exclusion criteria: * Severe aphasia / cognitive deficits interfering with study * Psychiatric disorders * Alcohol / drug addiction * Exclusion criteria related to MRI HEALTHY INDIVIDUALS: Inclusion Criteria: • 18-90 years Exclusion Criteria: * medical history with a previous stroke/neurological deficit * drug/alcohol abuse * psychiatric condition/ dementia CHRONIC STROKE PATIENTS: Inclusion Criteria: * chronic stroke (\>6 months) * aged 18-90 years * with a stroke lesion on brain imaging Exclusion Criteria: * difficulty in understanding or executing commands * drug/alcohol abuse * severe aphasia / cognitive deficits interfering with study * inability to voluntarily move the affected arm (i.e. complete paralysis of the arm) * multiple strokes / dementia / psychiatric condition
Where this trial is running
Yvoir, Namur and 1 other locations
- CHU UCL Namur — Yvoir, Namur, Belgium (RECRUITING)
- University Hospital CHU Dinant Godinne UCL — Yvoir, Belgium (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Yves Vandermeeren, MD, PhD — UCLouvain IONS
- Study coordinator: Yves Vandermeeren, MD, PhD
- Email: yves.vandermeeren@uclouvain.be
- Phone: +32 81 42 33 21
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stroke, Acute, Acute stroke, Motor skill learning, Upper limb, Rehabilitation, Subacute stroke