StrokeNCT00837460
Effect of Rehabilitation of Patients With a Central Nervous System Lesion
A study testing rehabilitation in people with Stroke, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The purpose of the study is to analyse the prehensions deficits and the effect of prehension rehabilitation in central nervous system lesioned people Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2006to Oct 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adult minimum 6mounth after first stroke
- Minimal prehension of both hands
Who cannot join
- Diabetuss
- Other Upper Limb pathologies
- MMSE < 26
Trial locations and contacts
1 site in 1 country.
Belgium1 site
READ : Rehabilitation and physical medecine Unit
Brussels, Brussels Capital, 1200
About this study
The purpose of the study is to analyse the prehensions deficits and the effect of prehension rehabilitation in central nervous system lesioned people
- Conditions
- Stroke
- Being tested
- rehabilitation
- Keywords
- Hand, Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rehabilitationOther
4 weeks of bilateral followed or preceded by 4 weeks of unilateral similar prehension oriented repeated rehabilitation tasks. About 45 minutes 3 times a week, the subject is coached by a physiotherapist to enhance his prehension habilities.
| Study group | Role | What they receive |
|---|---|---|
| rehabilitation | Experimental | Bilateral and unilateral prehension oriented rehabilitation to enhance prehension. Receives: Other: rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
prehension functionality
Measured: 4 weeks before, just before, after first part and after the second part of rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2009 (estimated)
- Study startSep 2006
- Primary completionSep 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Saint Luc, Fonds pour la recherche scientifique médicale (FRSM), Belgium, Association nationale d'aide aux personnes handicapées (ANAH)
- Investigators
- Delphine Dispa, PhD student, Principal investigator, Rehabilitation and physical medecine Unit - UCLJean-Louis Thonnard, PhD, Study director, Rehabilitation and physical medecine Unit-UCLYannick Bleyenheuft, PhD student, Principal investigator, Rehabilitation and physical medecine Unit-UCLThierry Lejeune, MD PhD, Study director, Rehabilitation and physical medecine Unit-UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837460
- Sponsor's protocol ID
- 2006/06NOV/207
- Status last verified
- Mar 2010
- First submitted
- 4 Feb 2009
- Last updated
- 30 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rehabilitation of Patients With a Central Nervous System Lesion
- ClinicalTrials.gov ID
- NCT00837460
- Acronym / sponsor ID
- 2006/06NOV/207
- Conditions
- Stroke
- Keywords
- Hand, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Fondation Saint Luc, Fonds pour la recherche scientifique médicale (FRSM), Belgium, Association nationale d'aide aux personnes handicapées (ANAH)
- Study start
- Sep 2006
- Primary completion
- Sep 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 5 Feb 2009 (estimated)
- 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.
The purpose of the study is to analyse the prehensions deficits and the effect of prehension rehabilitation in central nervous system lesioned people
Study design
- Primary purpose
- Supportive care
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rehabilitation | Experimental | Other: rehabilitationBilateral and unilateral prehension oriented rehabilitation to enhance prehension. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Adult minimum 6mounth after first stroke
- Minimal prehension of both hands
Key exclusion criteria (3 listed)
- Diabetuss
- Other Upper Limb pathologies
- MMSE < 26
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 |
|---|---|---|
| rehabilitation4 weeks of bilateral followed or preceded by 4 weeks of unilateral similar prehension oriented repeated rehabilitation tasks. About 45 minutes 3 times a week, the subject is coached by a physiotherapist to enhance his prehension habilities. | Other | rehabilitation |
Primary outcome
prehension functionality
Time frame: 4 weeks before, just before, after first part and after the second part of rehabilitation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2010.
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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. This study is not recruiting at the moment.
Delphine Dispa, PhD student principal investigator
Rehabilitation and physical medecine Unit - UCL
Jean-Louis Thonnard, PhD study director
Rehabilitation and physical medecine Unit-UCL
Yannick Bleyenheuft, PhD student principal investigator
Rehabilitation and physical medecine Unit-UCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rehabilitation in people with Stroke, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site 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 3 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: finished, as of the sponsor's last update on 30 Mar 2010. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prehension functionality (time frame: 4 weeks before, just before, after first part and after the second part of rehabilitation). 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 30 Mar 2010.