Influence of Handedness on Upper Limb Recovery (HANDISTROKE)

Centre Hospitalier Régional d'Orléans

Status: Begins enrollment this month

Conditions: Stroke

Treatments: Other: evaluation

Study type: Observational

Funder types: Other

Identifiers

NCT07357181

CHUO-2025-19

Details and patient eligibility

About

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.

Full 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).

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Confirmed unilateral recent stroke (less than 5 days).
2. Age 18 years and older.
3. Participant or proxy does not object to participation

Exclusion criteria

1. Prior stroke with residual motor sequelae.
2. Pre-stroke upper-limb deficit.
3. Follow-up at 6 months not planned at Orléans.
4. Protected adult (guardianship/curatorship), person under legal protection, or deprived of liberty.
5. Pregnant or breastfeeding woman.

Trial design

500 participants in 1 patient group

Patients with confirmed unilateral recent stroke

Treatment:

Other: evaluation