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

Stroke Clinical Trial

Official title:

Effectiveness of Botulinum Toxin Combined With Upper Limb Rehabilitation on Arm Function

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01511796
• Other study ID #: BTul Rehab
• Status: Enrolling by invitation
• Phase: Phase 3
• First received: January 6, 2012
• Last updated: January 17, 2012
• Start date: January 2012
• Est. completion date: April 2014

Study information

• Verified date: January 2012
• Source: Toronto Rehabilitation Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ministry of Health & Long Term Care, Ontario
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 38
• Est. completion date: April 2014
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 .

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• upper limb rehabiliation
3 months upper rehabilation (twice a week) and then 3 more months upper limb rehabitation ( twice a week)

Locations

Country	Name	City	State
Canada	Toronto Rehabiliation institute	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Toronto Rehabilitation Institute	University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Ashworth		up tp 2013	No
Secondary	Goal attaiment Scale		up tp 2013	No