- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01511796
Examining the Effectiveness of Combined Rehabilitation and Botulinum Toxin Injection on Functional Improvement of the Upper Limb After Stroke
January 17, 2012 updated by: Parvin Eftekhar, Toronto Rehabilitation Institute
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
38
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2A2
- Toronto Rehabiliation institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- significant cognitive and speech impairments
- other upper limb impairments such as frozen shoulder
- another diagnosis which could contribute to upper limb spasticity .
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: upper limb rehabilitation for total of 6 months
upper limb rehabiliation
|
3 months upper rehabilation (twice a week) and then 3 more months upper limb rehabitation ( twice a week)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Modified Ashworth
Time Frame: up tp 2013
|
up tp 2013
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Goal attaiment Scale
Time Frame: up tp 2013
|
up tp 2013
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (ANTICIPATED)
April 1, 2013
Study Completion (ANTICIPATED)
April 1, 2014
Study Registration Dates
First Submitted
January 6, 2012
First Submitted That Met QC Criteria
January 17, 2012
First Posted (ESTIMATE)
January 19, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
January 19, 2012
Last Update Submitted That Met QC Criteria
January 17, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BTul Rehab
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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