Trials / Not Yet Recruiting
Not Yet RecruitingNCT07357181
Influence of Handedness on Upper Limb Recovery
Impact of Manual Preference on Motor Deficits After Stroke
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 500 (estimated)
- Sponsor
- Centre Hospitalier Régional d'Orléans · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This prospective, single-center observational study evaluates whether handedness is associated with upper-limb motor recovery after a recent unilateral stroke. Adults admitted to the stroke unit with a confirmed unilateral stroke within 5 days are included if they do not object to participation. Upper-limb impairment is assessed early after stroke and at 6 months using standardized clinical scales. Handedness is determined by self-report, and the Edinburgh Handedness Inventory is administered when feasible. The main hypothesis is that left-handed participants may show better upper-limb motor recovery at 6 months than right-handed participants, potentially due to differences in brain motor network lateralization.
Detailed description
Participants hospitalized in the stroke unit with a confirmed unilateral stroke are recruited consecutively. After eligibility verification and absence of objection, baseline data are collected within 5 days post-stroke. Baseline assessments include the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE), the Shoulder Abduction and Finger Extension (SAFE) score, and the National Institutes of Health Stroke Scale (NIHSS) score (post-acute treatment if thrombolysis or thrombectomy was performed). Handedness is recorded after the motor assessments to maintain assessor blinding regarding group membership; the Edinburgh Handedness Inventory is administered when cognitive status allows. A 6-month follow-up is performed during routine post-stroke consultation at the study site, with repeat FMA-UE and SAFE assessments. The primary analysis compares FMA-UE at 6 months between left-handed and right-handed participants among those with baseline FMA-UE less than 66, using propensity score matching (3:1 right-handed to left-handed) accounting for age, baseline motor deficit, lesion side relative to dominance (dominant vs non-dominant hemisphere), and stroke type (ischemic vs hemorrhagic).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | evaluation | Patients will be evaluated at baseline for Edinburgh Handedness Inventory Laterality Quotient. Patients will be seen again at 6 months as part of their standard post-stroke consultation at Orléans University Hospital by a neurologist from the neurology department. In conjunction with this consultation, an assessment specific to this research study of the FMA-UE and SAFE scores will be carried out by a physiotherapist from the department. |
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2027-08-01
- Completion
- 2028-03-01
- First posted
- 2026-01-21
- Last updated
- 2026-01-29
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT07357181. Inclusion in this directory is not an endorsement.