Rehabilitation of upper limb function after stroke using mirror therapy
Intensive Rehabilitation Program With Intensive Visual Numerical Simulation Device for Improving Distal Motor Performance and Upper Limb Functional Capacity in Subacute Hemiparetics After Stroke. Randomized Controlled Trial.
This study is testing if using a special mirror therapy device can help people who have weakness in one arm after a stroke recover better than traditional rehab methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Clinique Les Trois Soleils Academic / other |
| Locations | 5 sites (Reims, Champagne-Ardenne and 4 other locations) |
| Trial ID | NCT04119544 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of mirror therapy using an Intensive Visual Simulation (IVS) device for patients with hemiparesis following a stroke. The study aims to compare the outcomes of structured movement repetition programs with conventional rehabilitation over a six-week period. By utilizing the IVS device, which creates an immersive experience for patients, the trial seeks to enhance motor control and functional abilities of the affected upper limb. The trial is multicentric and randomized, focusing on patients in the sub-acute phase of stroke recovery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have experienced a stroke with hemiparesis between 4 to 10 weeks prior and have limited wrist and hand function.
Not a fit: Patients with cognitive dysfunction, prior neurological conditions, or those who have previously undergone mirror therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve upper limb function and quality of life for stroke patients with hemiparesis.
How similar studies have performed: Previous studies have shown promise in using mirror therapy for stroke rehabilitation, suggesting potential success for this novel application with the IVS device.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years; * Stroke hemiparesis on unilateral focal lesion dating from 4 to 10 weeks at baseline; * Total sub-scores wrist and hand of th Fugl-Meyer \< 16 * Patient having agreed to sign an informed consent * patient being affiliated to the French Social Security Exclusion Criteria: * Cognitive dysfunction or progressive intercurrent illness making effective communication or participation in the study impossible * Phasic disorders that prevent the understanding of instructions * Patient include in an other clinical trial * Neurological conditions prior to stroke * Patient who had mirror therapy or IVS rehabilitation before inclusion * Rheumatological pathology of the hand and wrist * Person under legal protection measure.
Where this trial is running
Reims, Champagne-Ardenne and 4 other locations
- CHU Sébastopol — Reims, Champagne-Ardenne, France (Not_yet_recruiting)
- Clinique Napoléon — Saint-Paul-lès-Dax, New Aquitaine, France (Not_yet_recruiting)
- Clinique Les Trois Soleils — Boissise-le-Roi, France (Recruiting)
- CRF Pasori — Cosne-Cours-sur-Loire, France (Recruiting)
- Clinalliance Villiers-sur Orge — Villiers-sur-Orge, France (Recruiting)
Study contacts
- Principal investigator: Christophe DURET, MD — Clinique Les Trois Soleils
- Study coordinator: SAS Les POMPON
- Email: ag.grosmaire@les-trois-soleils.fr
- Phone: +33164718000
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.