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

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ClinicalTrials.gov Identifier: NCT01511796
Recruitment Status : Unknown
Verified January 2012 by Parvin Eftekhar, Toronto Rehabilitation Institute.
Recruitment status was:  Enrolling by invitation
First Posted : January 19, 2012
Last Update Posted : January 19, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Stroke Other: upper limb rehabiliation Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Botulinum Toxin Combined With Upper Limb Rehabilitation on Arm Function
Study Start Date : January 2012
Estimated Primary Completion Date : April 2013
Estimated Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

Primary Outcome Measures :
  1. Modified Ashworth [ Time Frame: up tp 2013 ]

Secondary Outcome Measures :
  1. Goal attaiment Scale [ Time Frame: up tp 2013 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01511796


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

Responsible Party: Parvin Eftekhar, principal inverstigator, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier: NCT01511796     History of Changes
Other Study ID Numbers: BTul Rehab
First Posted: January 19, 2012    Key Record Dates
Last Update Posted: January 19, 2012
Last Verified: January 2012

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

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs