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StrokeHANDISTROKENCT07357181

Influence of Handedness on Upper Limb Recovery

An observational study of Stroke, run by Centre Hospitalier Régional d'Orléans at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
evaluation
How many people
500 participants
Where
1 siteFrance
Study dates
2 Jun 2026to Oct 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Julien BONNAL, MK contact

00332 38 74 46 65

julien.bonnal@chu-orleans.fr

France1 site, 1 recruiting

  • CHU Orléans

    Orléans, 45067

    Julien BONNAL, MK, 0033238744665, julien.bonnal@chu-orleans.fr

    Julien BONNAL

    Recruiting

Other trials in France

About this study

Official title: 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.

Read the 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).

Conditions
Stroke
Being tested
evaluation
Keywords
Stroke, Handedness, Motricity, Upper Limb, Manual preference, Motor impairment, Motor recovery
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • evaluationOther

    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.

Study groups in NCT07357181
Study groupRoleWhat they receive
Patients with confirmed unilateral recent strokeNot described
Receives: Other: evaluation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: month 6

Secondary outcomes (6)

  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

    Measured: Baseline

  2. Proportion of Left-Handed Participants

    Measured: 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

    Measured: Baseline

  4. Number of Participants With Upper-Limb Weakness

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

    Measured: Baseline

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

    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)

    Measured: Baseline

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

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

    Measured: Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2026
  2. Study start2 Jun 2026
  3. Primary completionOct 2027 (estimated)
  4. Study completionOct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07357181
Sponsor's protocol ID
CHUO-2025-19
Acronym
HANDISTROKE
Status last verified
Jun 2026
First submitted
13 Jan 2026
Last updated
8 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 16885424

  • 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.

    PubMed 32237881

  • 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.

    PubMed 41218702

  • 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.

    PubMed 25705184

  • 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.

    PubMed 23652723

  • 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.

    PubMed 11554905

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, run by Centre Hospitalier Régional d'Orléans at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Julien BONNAL, MK (00332 38 74 46 65, julien.bonnal@chu-orleans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fugl-Meyer Assessment for Upper Extremity (FMA-UE) Score (time frame: month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07357181, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.

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