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NCT Number: NCT07357181

Influence of Handedness on Upper Limb Recovery

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Orléans

Orléans, 45067, France

Location status: Recruiting

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.
  • Pregnant or breastfeeding woman.

Treatment and study plan

Evaluation

Other

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.

Primary outcomes

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

    Time frame: month 6

    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.

Secondary outcomes

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

    Time frame: Baseline

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

  2. Proportion of Left-Handed Participants

    Time frame: Baseline

  3. Mean National Institutes of Health Stroke Scale (NIHSS) Score

    Time frame: Baseline

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

  4. Number of Participants With Upper-Limb Weakness

    Time frame: Baseline

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

  5. Correlation Between Edinburgh Handedness Inventory Laterality Quotient and Baseline FMA-UE Score

    Time frame: Baseline

    Score 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)

  6. Mean Shoulder Abduction and Finger Extension (SAFE) Score

    Time frame: Month 6

    Score from 0 to 10; the lower the score, the more severe the deficit.

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study title

Impact of Manual Preference on Motor Deficits After Stroke

Acronym: HANDISTROKE

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 21, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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