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

January 6, 2012
January 17, 2012
January 2012
April 2013   (final data collection date for primary outcome measure)
Modified Ashworth [ Time Frame: up tp 2013 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01511796 on ClinicalTrials.gov Archive Site
Goal attaiment Scale [ Time Frame: up tp 2013 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Examining the Effectiveness of Combined Rehabilitation and Botulinum Toxin Injection on Functional Improvement of the Upper Limb After Stroke
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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Stroke
Other: upper limb rehabiliation
3 months upper rehabilation (twice a week) and then 3 more months upper limb rehabitation ( twice a week)
Experimental: upper limb rehabilitation for total of 6 months
upper limb rehabiliation
Intervention: Other: upper limb rehabiliation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
38
April 2014
April 2013   (final data collection date for primary outcome measure)

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 .
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01511796
BTul Rehab
Yes
Parvin Eftekhar, Toronto Rehabilitation Institute
Toronto Rehabilitation Institute
University of Toronto
Not Provided
Toronto Rehabilitation Institute
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP