Cerebrovascular AccidentNCT00286702
Does Splinting Prevent Contractures Following Stroke?
A study testing hand splint in people with Cerebrovascular Accident, run by University of Western Sydney.
Trial summary
After a stroke, many people develop contracture of the muscles in their affected wrist and hand which leads to a permanently clenched, painful hand. A contracture is often treated by therapists who use hand splinting to prevent it occurring or slow down its progression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- hand splint
- Type of treatment
- Medical device
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- Oct 2002to Sep 2004
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- first ever stroke
- score of <1 on Motor Assessment Scale item 6
Who cannot join
- comorbidity resulting in previous contracture of the wrist/hand
About this study
After a stroke, many people develop contracture of the muscles in their affected wrist and hand which leads to a permanently clenched, painful hand. A contracture is often treated by therapists who use hand splinting to prevent it occurring or slow down its progression. Despite their wide use, there has not been research completed to investigate whether or not splinting prevents contracture in people following stroke. In fact, this project will be the first of its kind in the world and is therefore vital to stroke rehabilitation.
The study is a multi-centre, randomised controlled trial that will measure the effect of hand-splinting in two positions on the prevention of contracture, functional use of the hand, and quality of life.
- Conditions
- Cerebrovascular Accident
- Being tested
- hand splint
- Keywords
- splints, Occupational Therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hand splintDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2006 (estimated)
- Study startOct 2002
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentStudies 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
- Interventional
- Phase
- Phase N/A
- Enrolment
- 63 participants
Sponsor and investigators
- Lead sponsor
- University of Western Sydney
- Sponsor type
- University, hospital or other
- Investigators
- Natasha Lannin, BSc(OT), Principal investigator, University of Western SydneyAnne Cusick, PhD, Study chair, University of Western Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00286702
- Sponsor's protocol ID
- HEC 01/166
- Status last verified
- Jan 2006
- First submitted
- 1 Feb 2006
- Last updated
- 3 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Splinting Prevent Contractures Following Stroke?
- ClinicalTrials.gov ID
- NCT00286702
- Acronym / sponsor ID
- HEC 01/166
- Conditions
- Cerebrovascular Accident
- Keywords
- splints, Occupational Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants
- Lead sponsor
- University of Western SydneyUniversity, hospital or other
- Study start
- Oct 2002
- Study completion
- Sep 2004
- First posted
- 3 Feb 2006 (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.
After a stroke, many people develop contracture of the muscles in their affected wrist and hand which leads to a permanently clenched, painful hand. A contracture is often treated by therapists who use hand splinting to prevent it occurring or slow down its progression. Despite their wide use, there has not been research completed to investigate whether or not splinting prevents contracture in people following stroke. In fact, this project will be the first of its kind in the world and is therefore vital to stroke rehabilitation.
The study is a multi-centre, randomised controlled trial that will measure the effect of hand-splinting in two positions on the prevention of contracture, functional use of the hand, and quality of life.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- first ever stroke
- score of <1 on Motor Assessment Scale item 6
Key exclusion criteria (1 listed)
- comorbidity resulting in previous contracture of the wrist/hand
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 |
|---|---|---|
| hand splint | Device | – |
Primary outcome
Not reported in the source record.
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 3 Feb 2006.
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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.
Natasha Lannin, BSc(OT) principal investigator
University of Western Sydney
Anne Cusick, PhD study chair
University of Western Sydney
Questions about this trial
What is this clinical trial studying?
A study testing hand splint in people with Cerebrovascular Accident, run by University of Western Sydney.
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 1 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 3 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
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.
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 3 Feb 2006.