StrokePhase 3NCT01511796
Examining the Effectiveness of Combined Rehabilitation and Botulinum Toxin Injection on Functional Improvement of the Upper Limb After Stroke
A Phase 3 study testing upper limb rehabiliation in people with Stroke, run by Toronto Rehabilitation Institute at 1 site in Canada.
Trial summary
The purpose of this study is to examine the effects of a combination of "Botulinum Toxin (BT) and Upper Limb (UL) rehabilitation" compared to "BT only" on UL motor function in adults with spasticity after stroke using a pre-post design. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- upper limb rehabiliation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2012to Apr 2014
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 18 years of age
- at least 4 months post stroke
- present with UL spasticity (MAS >1 in elbow and/or spasticity of the hand, wrist or shoulder)
- present with at lease a stage 3 of CMSA
- able to comply with the requirements of the protocol and UL therapy programme.
Who cannot join
- significant cognitive and speech impairments
- other upper limb impairments such as frozen shoulder
- another diagnosis which could contribute to upper limb spasticity .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Botulinum Toxin Combined With Upper Limb Rehabilitation on Arm Function
The purpose of this study is to examine the effects of a combination of "Botulinum Toxin (BT) and Upper Limb (UL) rehabilitation" compared to "BT only" on UL motor function in adults with spasticity after stroke using a pre-post design. The research question is whether combination of BT and UL rehabilitation compared to BT only is more effective in improving the UL function, range of motion and pain.
- Conditions
- Stroke
- Being tested
- upper limb rehabiliation
- Keywords
- stroke, upper limb rehabilitation function
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
upper limb rehabiliationOther
3 months upper rehabilation (twice a week) and then 3 more months upper limb rehabitation ( twice a week)
| Study group | Role | What they receive |
|---|---|---|
| upper limb rehabilitation for total of 6 months | Experimental | upper limb rehabiliation Receives: Other: upper limb rehabiliation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth
Measured: up tp 2013
Secondary outcomes (1)
Goal attaiment Scale
Measured: up tp 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionApr 2013 (estimated)
- Study completionApr 2014 (estimated)
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toronto Rehabilitation Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Responsible party
- Principal investigator, Parvin Eftekhar, Toronto Rehabilitation Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511796
- Sponsor's protocol ID
- BTul Rehab
- Status last verified
- Jan 2012
- First submitted
- 6 Jan 2012
- Last updated
- 19 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Botulinum Toxin Combined With Upper Limb Rehabilitation on Arm Function
- ClinicalTrials.gov ID
- NCT01511796
- Acronym / sponsor ID
- BTul Rehab
- Conditions
- Stroke
- Keywords
- stroke, upper limb rehabilitation function
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Toronto Rehabilitation InstituteUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- Jan 2012
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 19 Jan 2012 (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 this study is to examine the effects of a combination of "Botulinum Toxin (BT) and Upper Limb (UL) rehabilitation" compared to "BT only" on UL motor function in adults with spasticity after stroke using a pre-post design. The research question is whether combination of BT and UL rehabilitation compared to BT only is more effective in improving the UL function, range of motion and pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| upper limb rehabilitation for total of 6 months | Experimental | Other: upper limb rehabiliationupper limb rehabiliation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- over 18 years of age
- at least 4 months post stroke
- present with UL spasticity (MAS >1 in elbow and/or spasticity of the hand, wrist or shoulder)
- present with at lease a stage 3 of CMSA
- able to comply with the requirements of the protocol and UL therapy programme.
Key exclusion criteria (3 listed)
- significant cognitive and speech impairments
- other upper limb impairments such as frozen shoulder
- another diagnosis which could contribute to upper limb spasticity .
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 |
|---|---|---|
| upper limb rehabiliation3 months upper rehabilation (twice a week) and then 3 more months upper limb rehabitation ( twice a week) | Other | upper limb rehabilitation for total of 6 months |
Primary outcome
Modified Ashworth
Time frame: up tp 2013
1 secondary outcome
Goal attaiment Scale
Time frame: up tp 2013
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing upper limb rehabiliation in people with Stroke, run by Toronto Rehabilitation Institute at 1 site in Canada.
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 5 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: status not confirmed, as of the sponsor's last update on 19 Jan 2012. 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 Canada. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Modified Ashworth (time frame: up tp 2013). 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 19 Jan 2012.