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
  Purpose

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.


Condition Intervention Phase
Stroke
Other: upper limb rehabiliation
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of Botulinum Toxin Combined With Upper Limb Rehabilitation on Arm Function

Resource links provided by NLM:


Further study details as provided by Toronto Rehabilitation Institute:

Primary Outcome Measures:
  • Modified Ashworth [ Time Frame: up tp 2013 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Goal attaiment Scale [ Time Frame: up tp 2013 ] [ Designated as safety issue: No ]

Estimated Enrollment: 38
Study Start Date: January 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: upper limb rehabilitation for total of 6 months
upper limb rehabiliation
Other: upper limb rehabiliation
3 months upper rehabilation (twice a week) and then 3 more months upper limb rehabitation ( twice a week)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 .
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01511796

Locations
Canada, Ontario
Toronto Rehabiliation institute
Toronto, Ontario, Canada, M5G 2A2
Sponsors and Collaborators
Toronto Rehabilitation Institute
University of Toronto
  More Information

No publications provided

Responsible Party: Parvin Eftekhar, principal inverstigator, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier: NCT01511796     History of Changes
Other Study ID Numbers: BTul Rehab
Study First Received: January 6, 2012
Last Updated: January 17, 2012
Health Authority: Canada: Ministry of Health & Long Term Care, Ontario

Keywords provided by Toronto Rehabilitation Institute:
stroke
upper limb rehabilitation function

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Botulinum Toxins
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014