NCT06569771

Brief Summary

This study is being carried out in the context of rehabilitation after stroke, where persistent upper limb weakness is a major challenge. It aims to explore the relationship between observed function and patients' perceived participation in use.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
20mo left

Started Jun 2024

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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 Progress54%
Jun 2024Dec 2027

Study Start

First participant enrolled

June 11, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 26, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

2.6 years

First QC Date

August 19, 2024

Last Update Submit

April 8, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • To assess whether the perception of use of the impaired upper limb improves during intensive rehabilitation after a stroke.

    various tests : computer adaptive test F-M, ARA test, MIF test, star concellation test, ACTIVLIM test

    Up to 2 months

  • To compare the difference between perception and observed function of the upper limb during intensive multidisciplinary rehabilitation treatment.

    various tests : computer adaptive test F-M, ARA test, MIF test, star concellation test, ACTIVLIM test

    Up to 2 months

Study Arms (1)

Patients suffering from motor impairment of the upper limbs following a stroke

Voluntary patients suffering from motor impairment of the upper limbs following a stroke

Diagnostic Test: Functional assessments

Interventions

Functional assessmentsDIAGNOSTIC_TEST

* Computer Adaptive Test for Fugl-Meyer (CAT-FM) * Action Research Arm Test (ARAT) * Measurement of Functional Independence * Star cancellation test * Stroke Impact Scale * ACTIVLIM (assesses the ability to perform activities of daily living requiring the use of the upper limbs)

Patients suffering from motor impairment of the upper limbs following a stroke

Eligibility Criteria

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

Patients who have suffered a first stroke will be selected on transfer to a neurological rehabilitation service. They will be recruited on admission, provided they meet the inclusion and exclusion criteria. A combination of self-administered questionnaires and functional assessments will be carried out on the first day of multidisciplinary management in the neurological rehabilitation department and after two months in hospital.

You may qualify if:

  • First stroke as defined by the World Health Organization.
  • Upper limb paresis with a NIHSS National Institutes of Health Stroke Scale score \> or = 1/4 for upper limb motor function

You may not qualify if:

  • Life expectancy \<12 months
  • Inability to understand French.
  • Pre-existing severe multiple disability affecting arm function.
  • Presence of pre-existing central neurological pathologies.
  • Mini-Mental State Examination \< 21

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Grand Hôpital de Charleroi

Charleroi, Hainaut, 6060, Belgium

RECRUITING

CHU HELORA site Kennedy

Mons, Hainaut, 7000, Belgium

RECRUITING

Study Officials

  • Maxime Valet, MD

    Grand Hôpital de Charleroi

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maxime VALET, MD

CONTACT

Study Design

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

Study Record Dates

First Submitted

August 19, 2024

First Posted

August 26, 2024

Study Start

June 11, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations