NCT05454748

Brief Summary

Aim: To assess whether a cognitively demanding dual-task has greater impact on manual dexterity in chronic stroke patients than in healthy subjects. Methods: A visuomotor force-tracking task, combining grip force and oculomotor recordings, will be applied in chronic stroke patients with mild-moderate hemiparesis without clinical cognitive impairments and in age-comparable healthy subjects. The dual-task includes avoiding visual distractors and mental addition of numbers. Dual-task effect is calculated as difference in force control accuracy (dual minus single-task) and as difference in saccade rate (addition of numbers minus visual distractors).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 12, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2023

Completed
Last Updated

March 1, 2024

Status Verified

June 1, 2022

Enrollment Period

1.4 years

First QC Date

June 27, 2022

Last Update Submit

February 29, 2024

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Saccade inhibition rate

    Cross sectional comparison of % of saccades performed towards visual distractors

    Baseline measurement (one occasion)

Study Arms (2)

Healthy controls

Stroke patients

Eligibility Criteria

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

Stroke patients group and Age comparable healthy controls group

You may qualify if:

  • \> 18 years old
  • First symptomatic stroke more than 3 months ago
  • Box and blocks test score \< 52
  • Mini Mental State Examination Test \> 25

You may not qualify if:

  • Psychiatric disease
  • Risk of Pregnancy
  • History of previous stroke
  • Disability that may interfere with the performance of tasks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GHU Sainte Anne

Paris, France

Location

Related Publications (1)

  • Dziezuk E, Le Boterff Q, Van Ravestyn C, Mairesse S, Hamdoun S, Calvet D, Daghsen L, Carment L, Rosso C, Maier MA, Turc G, Mas JL, G Lindberg P. Divided attention and manual visuomotor control in stroke: a combined dual-task and eye movement study. J Neuroeng Rehabil. 2025 Oct 10;22(1):212. doi: 10.1186/s12984-025-01735-4.

    PMID: 41074170DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

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

Study Record Dates

First Submitted

June 27, 2022

First Posted

July 12, 2022

Study Start

February 3, 2022

Primary Completion

June 20, 2023

Study Completion

June 20, 2023

Last Updated

March 1, 2024

Record last verified: 2022-06

Locations

FR(1)