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

NCT ID: NCT01511796

Last Updated: 2012-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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upper limb rehabilitation for total of 6 months

upper limb rehabiliation

Group Type EXPERIMENTAL

upper limb rehabiliation

Intervention Type OTHER

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

Interventions

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upper limb rehabiliation

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

Intervention Type OTHER

Eligibility Criteria

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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 .
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Toronto

OTHER

Sponsor Role collaborator

Toronto Rehabilitation Institute

OTHER

Sponsor Role lead

Responsible Party

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Parvin Eftekhar

principal inverstigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Toronto Rehabiliation institute

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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BTul Rehab

Identifier Type: -

Identifier Source: org_study_id

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