Upper Limb IschemiaValetM-2024NCT06569771
Evolution of the Patient's Perception of the Use of the Upper Limb After a Stroke During Intensive Rehabilitation
An observational study of Upper Limb Ischemia, run by Grand Hôpital de Charleroi at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Limb Ischemia
- What is being tested?
- Functional assessments
- How many people
- 100 participants
- Where
- 2 sitesBelgium
- Study dates
- 11 Jun 2024to 31 Dec 2027
- 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: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium2 sites, 2 recruiting
- Recruiting
Grand Hôpital de Charleroi
Charleroi, Hainaut, 6060
Maxime VALET, MSc, 0032 60 ext. 119424, maxime.valet@ghdc.be
- Recruiting
CHU HELORA site Kennedy
Mons, Hainaut, 7000
Benjamin BOLLENS, MD, benjamin.bollens@helora.be
About this study
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.
- Conditions
- Upper Limb Ischemia
- Being tested
- Functional assessments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Functional assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start11 Jun 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Limb IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grand Hôpital de Charleroi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maxime Valet, MD, Principal investigator, Grand Hôpital de Charleroi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569771
- Sponsor's protocol ID
- Perception Valet M 2024
- Acronym
- ValetM-2024
- Status last verified
- Apr 2026
- First submitted
- 19 Aug 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of the Patient's Perception of the Use of the Upper Limb After a Stroke During Intensive Rehabilitation
- ClinicalTrials.gov ID
- NCT06569771
- Acronym / sponsor ID
- ValetM-2024 / Perception Valet M 2024
- Conditions
- Upper Limb Ischemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Grand Hôpital de CharleroiUniversity, hospital or other
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients suffering from motor impairment of the upper limbs following a stroke | – | Diagnostic Test: Functional assessmentsVoluntary patients suffering from motor impairment of the upper limbs following a stroke |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional assessments* 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) | Diagnostic test | Patients suffering from motor impairment of the upper limbs following a stroke |
Primary outcome
To assess whether the perception of use of the impaired upper limb improves during intensive rehabilitation after a stroke.
Time frame: Up to 2 months
various tests : computer adaptive test F-M, ARA test, MIF test, star concellation test, ACTIVLIM test
To compare the difference between perception and observed function of the upper limb during intensive multidisciplinary rehabilitation treatment.
Time frame: Up to 2 months
various tests : computer adaptive test F-M, ARA test, MIF test, star concellation test, ACTIVLIM test
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maxime Valet, MD principal investigator
Grand Hôpital de Charleroi
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Limb Ischemia, run by Grand Hôpital de Charleroi at 2 sites in Belgium.
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 2 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 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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 Maxime VALET, MD (0032 60 ext. 119424, Maxime.VALET@ghdc.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess whether the perception of use of the impaired upper limb improves during intensive rehabilitation after a stroke. (time frame: Up to 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2026.