NCT07357181

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
28mo left

Started Jun 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Jun 2026Oct 2028

First Submitted

Initial submission to the registry

January 13, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

June 2, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

1.3 years

First QC Date

January 13, 2026

Last Update Submit

June 5, 2026

Conditions

Keywords

StrokeHandednessMotricityUpper LimbManual preferenceMotor impairmentMotor recovery

Outcome Measures

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.

    month 6

Secondary Outcomes (6)

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

    Baseline

  • Proportion of Left-Handed Participants

    Baseline

  • Mean National Institutes of Health Stroke Scale (NIHSS) Score

    Baseline

  • Number of Participants With Upper-Limb Weakness

    Baseline

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

    Baseline

  • +1 more secondary outcomes

Study Arms (1)

Patients with confirmed unilateral recent stroke

Other: evaluation

Interventions

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.

Patients with confirmed unilateral recent stroke

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Orléans

Orléans, 45067, France

RECRUITING

Related Publications (6)

  • Harris JE, Eng JJ. Individuals with the dominant hand affected following stroke demonstrate less impairment than those with the nondominant hand affected. Neurorehabil Neural Repair. 2006 Sep;20(3):380-9. doi: 10.1177/1545968305284528.

    PMID: 16885424BACKGROUND
  • Papadatou-Pastou M, Ntolka E, Schmitz J, Martin M, Munafo MR, Ocklenburg S, Paracchini S. Human handedness: A meta-analysis. Psychol Bull. 2020 Jun;146(6):481-524. doi: 10.1037/bul0000229. Epub 2020 Apr 2.

    PMID: 32237881BACKGROUND
  • Bonnal J, Pila O, Papin C, Lebkowski L, Sarrazin M, Bravo R, Prieur F. Handedness and task demands modulate motor cortex lateralization: A cross-sectional fNIRS study. Neuroimage. 2025 Dec 1;323:121578. doi: 10.1016/j.neuroimage.2025.121578. Epub 2025 Nov 9.

    PMID: 41218702BACKGROUND
  • Tzourio-Mazoyer N, Petit L, Zago L, Crivello F, Vinuesa N, Joliot M, Jobard G, Mellet E, Mazoyer B. Between-hand difference in ipsilateral deactivation is associated with hand lateralization: fMRI mapping of 284 volunteers balanced for handedness. Front Hum Neurosci. 2015 Feb 6;9:5. doi: 10.3389/fnhum.2015.00005. eCollection 2015.

    PMID: 25705184BACKGROUND
  • Darling WG, Helle N, Pizzimenti MA, Rotella DL, Hynes SM, Ge J, Stilwell-Morecraft KS, Morecraft RJ. Laterality affects spontaneous recovery of contralateral hand motor function following motor cortex injury in rhesus monkeys. Exp Brain Res. 2013 Jul;228(1):9-24. doi: 10.1007/s00221-013-3533-1. Epub 2013 May 8.

    PMID: 23652723BACKGROUND
  • Solodkin A, Hlustik P, Noll DC, Small SL. Lateralization of motor circuits and handedness during finger movements. Eur J Neurol. 2001 Sep;8(5):425-34. doi: 10.1046/j.1468-1331.2001.00242.x.

    PMID: 11554905BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2026

First Posted

January 21, 2026

Study Start

June 2, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2028

Last Updated

June 8, 2026

Record last verified: 2026-06

Locations