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

Toronto Rehabilitation Institute

Status and phase: Unknown; Phase 3

Conditions: Stroke

Treatments: Other: upper limb rehabiliation

Study type: Interventional

Funder types: Other

Identifiers

NCT01511796

BTul Rehab

Details and patient eligibility

About

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.

Enrollment: 38 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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 .

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

upper limb rehabilitation for total of 6 months

Experimental group

Description:

upper limb rehabiliation

Treatment:

Other: upper limb rehabiliation