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

Primary Purpose

Stroke

Status
Unknown status
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
upper limb rehabiliation
Sponsored by
Toronto Rehabilitation Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, upper limb rehabilitation function

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 .

Sites / Locations

  • Toronto Rehabiliation institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

upper limb rehabilitation for total of 6 months

Arm Description

upper limb rehabiliation

Outcomes

Primary Outcome Measures

Modified Ashworth

Secondary Outcome Measures

Goal attaiment Scale

Full Information

First Posted
January 6, 2012
Last Updated
January 17, 2012
Sponsor
Toronto Rehabilitation Institute
Collaborators
University of Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT01511796
Brief Title
Examining the Effectiveness of Combined Rehabilitation and Botulinum Toxin Injection on Functional Improvement of the Upper Limb After Stroke
Official Title
Effectiveness of Botulinum Toxin Combined With Upper Limb Rehabilitation on Arm Function
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
April 2013 (Anticipated)
Study Completion Date
April 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Toronto Rehabilitation Institute
Collaborators
University of Toronto

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, upper limb rehabilitation function

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
upper limb rehabilitation for total of 6 months
Arm Type
Experimental
Arm Description
upper limb rehabiliation
Intervention Type
Other
Intervention Name(s)
upper limb rehabiliation
Intervention Description
3 months upper rehabilation (twice a week) and then 3 more months upper limb rehabitation ( twice a week)
Primary Outcome Measure Information:
Title
Modified Ashworth
Time Frame
up tp 2013
Secondary Outcome Measure Information:
Title
Goal attaiment Scale
Time Frame
up tp 2013

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 .
Facility Information:
Facility Name
Toronto Rehabiliation institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2A2
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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