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Influence of Handedness on Upper Limb Recovery

Impact of Manual Preference on Motor Deficits After Stroke

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07357181
Acronym
HANDISTROKE
Enrollment
500
Registered
2026-01-21
Start date
2026-06-02
Completion date
2028-10-01
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Stroke, Handedness, Motricity, Upper Limb, Manual preference, Motor impairment, Motor recovery

Brief 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).

Interventions

OTHERevaluation

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.

Sponsors

Centre Hospitalier Régional d'Orléans
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Fugl-Meyer Assessment for Upper Extremity (FMA-UE) Scoremonth 6Upper-limb motor impairment measured using the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE) at 6 months post-stroke. Scores range from 0 to 66, with higher scores indicating less impairment. Primary analysis is performed among participants with baseline FMA-UE less than 66.

Secondary

MeasureTime frameDescription
Mean Fugl-Meyer Assessment for Upper Extremity (FMA-UE) ScoreBaselineScore from 0 to 66; the lower the score, the more severe the deficit
Proportion of Left-Handed ParticipantsBaseline
Mean National Institutes of Health Stroke Scale (NIHSS) ScoreBaselineScore from 0 to 42; the higher the score, the more severe the deficit
Number of Participants With Upper-Limb WeaknessBaselineNumber of Participants With Upper-Limb Weakness Defined as SAFE Score Less Than 10
Correlation Between Edinburgh Handedness Inventory Laterality Quotient and Baseline FMA-UE ScoreBaselineScore from -100 to +100, no notion of severity here since it assesses manual preference (at -100 you are very left-handed and at +100 you are very right-handed)
Mean Shoulder Abduction and Finger Extension (SAFE) ScoreMonth 6Score from 0 to 10; the lower the score, the more severe the deficit.

Countries

France

Contacts

CONTACTJulien BONNAL, MK
julien.bonnal@chu-orleans.fr00332 38 74 46 65

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 9, 2026