Examining the Effectiveness of Combined Rehabilitation and Botulinum Toxin Injection on Functional Improvement of the Upper Limb After Stroke

This study is enrolling participants by invitation only.

Sponsor:

Collaborator:

University of Toronto

Information provided by (Responsible Party):

Parvin Eftekhar, Toronto Rehabilitation Institute

ClinicalTrials.gov Identifier:

NCT01511796

First received: January 6, 2012

Last updated: January 17, 2012

Last verified: January 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 6, 2012
Last Updated Date	January 17, 2012
Start Date ^ICMJE	January 2012
Estimated Primary Completion Date	April 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 17, 2012)	Modified Ashworth [ Time Frame: up tp 2013 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01511796 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 17, 2012)	Goal attaiment Scale [ Time Frame: up tp 2013 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Examining the Effectiveness of Combined Rehabilitation and Botulinum Toxin Injection on Functional Improvement of the Upper Limb After Stroke
Official Title ^ICMJE	Effectiveness of Botulinum Toxin Combined With Upper Limb Rehabilitation on Arm Function
Brief 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. 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Stroke
Intervention ^ICMJE	Other: upper limb rehabiliation 3 months upper rehabilation (twice a week) and then 3 more months upper limb rehabitation ( twice a week)
Study Arm (s)	Experimental: upper limb rehabilitation for total of 6 months upper limb rehabiliation Intervention: Other: upper limb rehabiliation
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	38
Estimated Completion Date	April 2014
Estimated Primary Completion Date	April 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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 .
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Canada

Administrative Information
NCT Number ^ICMJE	NCT01511796
Other Study ID Numbers ^ICMJE	BTul Rehab
Has Data Monitoring Committee	Yes
Responsible Party	Parvin Eftekhar, Toronto Rehabilitation Institute
Study Sponsor ^ICMJE	Toronto Rehabilitation Institute
Collaborators ^ICMJE	University of Toronto
Investigators ^ICMJE	Not Provided
Information Provided By	Toronto Rehabilitation Institute
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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