Health TrialsbyHealthPanel

Influence of Handedness on Upper Limb Recovery

ConditionStroke
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Régional d'Orléans

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed unilateral recent stroke (less than 5 days).

Age 18 years and older.

Participant or proxy does not object to participation

Disqualifiers

Prior stroke with residual motor sequelae.

Pre-stroke upper-limb deficit.

Follow-up at 6 months not planned at Orléans.

Protected adult (guardianship/curatorship), person under legal protection, or deprived of liberty.

Trial population

Adults hospitalized in the stroke unit of Orléans University Hospital with a confirmed unilateral recent stroke.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • evaluation

    Other intervention

    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.

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Patients with confirmed unilateral recent stroke1 intervention

Trial outcomes

Primary outcomes

1

Fugl-Meyer Assessment for Upper Extremity (FMA-UE) Score

Upper-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.

Time frame
month 6

Secondary outcomes

1

Mean Fugl-Meyer Assessment for Upper Extremity (FMA-UE) Score

Score from 0 to 66; the lower the score, the more severe the deficit

Time frame
Baseline
2

Proportion of Left-Handed Participants

Time frame
Baseline
3

Mean National Institutes of Health Stroke Scale (NIHSS) Score

Score from 0 to 42; the higher the score, the more severe the deficit

Time frame
Baseline
4

Number of Participants With Upper-Limb Weakness

Number of Participants With Upper-Limb Weakness Defined as SAFE Score Less Than 10

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Régional d'Orléans

Lead sponsor

Source ClinicalTrials.gov
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