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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01511796
Enrollment
38
Registered
2012-01-19
Start date
2012-01-31
Completion date
2014-04-30
Last updated
2012-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

stroke, upper limb rehabilitation function

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.

Interventions

OTHERupper limb rehabiliation

3 months upper rehabilation (twice a week) and then 3 more months upper limb rehabitation ( twice a week)

Sponsors

University of Toronto
CollaboratorOTHER
Toronto Rehabilitation Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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 .

Design outcomes

Primary

MeasureTime frame
Modified Ashworthup tp 2013

Secondary

MeasureTime frame
Goal attaiment Scaleup tp 2013

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026