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

• Sponsor: Toronto Rehabilitation Institute (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01511796
• Collaborator: University of Toronto (Other)
• Enrollment: 38
• Location: 1
• Arm: 1
• Duration (Months): 27
• Patients Per Site Per Month: 1.4

Study Details

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
• Anticipated Enrollment: 38 participants
• Allocation: N/A
• 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: Jan 1, 2012
• Anticipated Primary Completion Date: Apr 1, 2013
• Anticipated Study Completion Date: Apr 1, 2014

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 [up tp 2013]

Secondary Outcome Measures

1. Goal attaiment Scale [up tp 2013]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Toronto Rehabiliation institute	Toronto	Ontario	Canada	M5G 2A2

Sponsors and Collaborators

• Toronto Rehabilitation Institute
• University of Toronto

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Parvin Eftekhar, principal inverstigator, Toronto Rehabilitation Institute
• ClinicalTrials.gov Identifier: NCT01511796
• Other Study ID Numbers: BTul Rehab
• First Posted: Jan 19, 2012
• Last Update Posted: Jan 19, 2012
• Last Verified: Jan 1, 2012

• Keywords provided by Parvin Eftekhar, principal inverstigator, Toronto Rehabilitation Institute: stroke; upper limb rehabilitation function
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of Jan 19, 2012