Influence of Handedness on Upper Limb Recovery (HANDISTROKE)

June 5, 2026 updated by: Centre Hospitalier Régional d'Orléans

Impact of Manual Preference on Motor Deficits After Stroke

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Orléans, France, 45067
        • Recruiting
        • CHU Orléans
        • Principal Investigator:
          • Julien BONNAL
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with confirmed unilateral recent stroke
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Left-Handed Participants
Time Frame: Baseline
Baseline
Number of Participants With Upper-Limb Weakness
Time Frame: Baseline
Number of Participants With Upper-Limb Weakness Defined as SAFE Score Less Than 10
Baseline
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
Baseline
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
Baseline
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)
Baseline
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.
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Régional d'Orléans

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

January 13, 2026

First Submitted That Met QC Criteria

January 13, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 5, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUO-2025-19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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