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

January 17, 2012 updated by: Parvin Eftekhar, Toronto Rehabilitation Institute

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

38

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M5G 2A2
        • Toronto Rehabiliation institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: upper limb rehabilitation for total of 6 months
upper limb rehabiliation
3 months upper rehabilation (twice a week) and then 3 more months upper limb rehabitation ( twice a week)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Modified Ashworth
Time Frame: up tp 2013
up tp 2013

Secondary Outcome Measures

Outcome Measure
Time Frame
Goal attaiment Scale
Time Frame: up tp 2013
up tp 2013

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ANTICIPATED)

April 1, 2013

Study Completion (ANTICIPATED)

April 1, 2014

Study Registration Dates

First Submitted

January 6, 2012

First Submitted That Met QC Criteria

January 17, 2012

First Posted (ESTIMATE)

January 19, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 19, 2012

Last Update Submitted That Met QC Criteria

January 17, 2012

Last Verified

January 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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