search
Back to results

Botulinum Toxin Type A and Modified Constraint-Induced Movement Therapy for Poststroke Upper Extremity Spasticity

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BtxA+mCIMT
BtxA+ conventional rehabilitation
Sponsored by
Kaohsiung Veterans General Hospital.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Botulinum toxin, Spasticity, Stroke, Rehabilitation.

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age 18 to 80 years
  • at least 1 year after a unilateral stroke
  • modified ashworth scale (MAS) score > 3 in the elbow, wrist or finger flexors
  • ability to actively extend > 10 degrees at metacarpophalangeal and interphalangeal joints and 20 degrees at wrist of the affected upper limb (minimal motor criteria).

Exclusion Criteria:

  • presence of fixed joint contractures
  • serious balance problems
  • preexisting neurological deficits, neuromuscular diseases or uncontrolled medical conditions
  • significant cognitive deficits (Mini-Mental Status Examination score < 24)
  • excessive pain in the affected upper limb
  • previous treatment with Botulinum toxin A, neurolytic agents or surgery for spasticity

All patients were not currently participating in any experimental studies and did not receive concomitant oral anti-spastic medication during the study period

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    BtxA+mCIMT (combination group)

    BtxA+ conventional rehabilitation (control group)

    Outcomes

    Primary Outcome Measures

    The primary outcome assessed spasticity on the Modified Ashworth Scale.

    Secondary Outcome Measures

    Secondary outcomes assessed real-world arm function (Motor Activity Log), laboratory motor activity (Action Research Arm Test) and patients' global satisfaction.

    Full Information

    First Posted
    July 25, 2008
    Last Updated
    July 29, 2008
    Sponsor
    Kaohsiung Veterans General Hospital.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00723866
    Brief Title
    Botulinum Toxin Type A and Modified Constraint-Induced Movement Therapy for Poststroke Upper Extremity Spasticity
    Official Title
    Combined Botulinum Toxin Type A With Modified Constraint-Induced Movement Therapy for Chronic Stroke Patients With Upper Extremity Spasticity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2005 (undefined)
    Primary Completion Date
    November 2007 (Actual)
    Study Completion Date
    June 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Kaohsiung Veterans General Hospital.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Botulinum toxin type A (BtxA) injection and modified constraint-induced movement therapy (mCIMT) are both promising approaches to enhance recovery after stroke. However, the combined application of the two modalities has rarely been studied. The aim was to investigate whether combined BtxA and mCIMT would produce greater improvements in spasticity and upper extremity function than BtxA plus conventional rehabilitation in chronic stroke patients with upper extremity spasticity.
    Detailed Description
    Botulinum toxin type A (BtxA) injection and modified constraint-induced movement therapy (mCIMT)are both promising approaches to enhance recovery after stroke. However, the combined application of the two modalities has rarely been studied. To date, only a single case report addressed this issue. Theoretically, application of a mCIMT program with intensive functional tasks practice after spasticity reduction by BtxA may improve affected upper extremity function in patients with poststroke spasticity. The aim was to investigate whether combined BtxA and mCIMT would produce greater improvements in spasticity and upper extremity function than BtxA plus conventional rehabilitation in chronic stroke patients with upper extremity spasticity.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke
    Keywords
    Botulinum toxin, Spasticity, Stroke, Rehabilitation.

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    32 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    BtxA+mCIMT (combination group)
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    BtxA+ conventional rehabilitation (control group)
    Intervention Type
    Other
    Intervention Name(s)
    BtxA+mCIMT
    Other Intervention Name(s)
    the combination group
    Intervention Description
    The combination group receive BtxA+mCIMT for 2 hours/day, 3 days/week for 3 months.
    Intervention Type
    Other
    Intervention Name(s)
    BtxA+ conventional rehabilitation
    Other Intervention Name(s)
    the control group
    Intervention Description
    The control group received for 2 hours/day, 3 days/week for 3 months.
    Primary Outcome Measure Information:
    Title
    The primary outcome assessed spasticity on the Modified Ashworth Scale.
    Time Frame
    MAS evaluated before BtxA injection, at 4 weeks, 3 months and 6 months postinjection.
    Secondary Outcome Measure Information:
    Title
    Secondary outcomes assessed real-world arm function (Motor Activity Log), laboratory motor activity (Action Research Arm Test) and patients' global satisfaction.
    Time Frame
    evaluated before BtxA injection, at 4 weeks, 3 months and 6 months postinjection.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age 18 to 80 years at least 1 year after a unilateral stroke modified ashworth scale (MAS) score > 3 in the elbow, wrist or finger flexors ability to actively extend > 10 degrees at metacarpophalangeal and interphalangeal joints and 20 degrees at wrist of the affected upper limb (minimal motor criteria). Exclusion Criteria: presence of fixed joint contractures serious balance problems preexisting neurological deficits, neuromuscular diseases or uncontrolled medical conditions significant cognitive deficits (Mini-Mental Status Examination score < 24) excessive pain in the affected upper limb previous treatment with Botulinum toxin A, neurolytic agents or surgery for spasticity All patients were not currently participating in any experimental studies and did not receive concomitant oral anti-spastic medication during the study period
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shu-Fen Sun, MD
    Organizational Affiliation
    Department of Physical Medicine and Rehabilitation
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17012643
    Citation
    Sun SF, Hsu CW, Hwang CW, Hsu PT, Wang JL, Yang CL. Application of combined botulinum toxin type A and modified constraint-induced movement therapy for an individual with chronic upper-extremity spasticity after stroke. Phys Ther. 2006 Oct;86(10):1387-97. doi: 10.2522/ptj.20050262.
    Results Reference
    background

    Learn more about this trial

    Botulinum Toxin Type A and Modified Constraint-Induced Movement Therapy for Poststroke Upper Extremity Spasticity

    We'll reach out to this number within 24 hrs