ClinicalTrials.gg
RecruitingNCT07357181HANDISTROKEUpdated Jun 8, 2026

Influence of Handedness on Upper Limb Recovery

An observational study in Stroke, sponsored by Centre Hospitalier Régional d'Orléans. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-08.

Sponsored by Centre Hospitalier Régional d'Orléans · Observational

From the registry’s dates

  • Started Jun 2026; still recruiting 5 months later.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 543 studies in Stroke with a site in France — 141 open to participants now, 160 under way, 12 of them phase 3. Stroke · France.

Planned enrollment
47th of 173
500 · median 180
Started
2026
with 29 others
Observational
175 of 543
34 open now
Primary completion
2027-10
later than 95 of 159 live
Registered
522nd of 543
by date

Among the 543 studies in Stroke with a site in France, this one is the 47th largest by planned enrollment of the 173 observational ones that give a count, is one of 30 that started in 2026, is one of 175 observational ones, reaches primary completion later than 95 of the 159 other live ones, and was the 522nd registered.

Stroke

8,268 studies on the registry are indexed under Stroke; 2,062 are open to participants now.

Browse Stroke studies →

Open to participants now

141 of the 543 studies in Stroke with a site in France are open now. Recruiting first, the newest first:

135 more — sign in →

All 141 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 1,418 Stroke studies recruiting now, 696 (49%) set no upper age limit and 282 (20%) stop at 75 or younger; 77 take children under 18; 196 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

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).

03

Conditions studied

  • Stroke

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Keywords

  • Stroke
  • Handedness
  • Motricity
  • Upper Limb
  • Manual preference
  • Motor impairment
  • Motor recovery
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with confirmed unilateral recent stroke

    Other: evaluation

Interventions

  • Otherevaluation

    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.

06

What researchers measure

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

  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)

    Time frame: Baseline

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

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

    Time frame: Month 6

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Oct 2027, 16 months after the start.

Of 837 non-industry observational studies under Stroke, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 92. This study's planned 16 months is below that.

Counting every sponsor, half of 899 studies reached it within 40 months; a quarter within 18 and three quarters within 85.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 13, 2026
First posted
Jan 21, 2026
StartActual
Jun 2, 2026
Primary completionEst.
Oct 2027
CompletionEst.
Oct 2028
Last update
Jun 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07357181
Responsible party
Sponsor
First posted
Jan 21, 2026
Start date
Jun 2, 2026
Primary completion
Oct 2027 (estimated)
Completion
Oct 2028 (estimated)
Last update
Jun 8, 2026

Study contacts

Julien BONNAL, MK
Contact
julien.bonnal@chu-orleans.fr
00332 38 74 46 65

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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