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Hand Rehabilitation Using Botulinum Toxin and Functional Electrical Stimulation-pilot Study

Primary Purpose

Stroke, Spastic Hemiparesis, Spasticity as Sequela of Stroke

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Botulinum Toxin Type A 100 unit/Vial (Product)
Sponsored by
National Rehabilitation Center, Seoul, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, hand, botulinum toxin, functional electrical stimulation

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age over 18 years
  • hemiplegic upper limb spasticity secondary to a unilateral ischemic or hemorrhagic stroke
  • fingers and wrist flexor spasticity graded at least 1+ on the Modified Ashworth Scale
  • at least 6 months since stroke

Exclusion Criteria:

  • fixed contracture
  • previous treatment of the upper limb spasticity with neurolytic or surgical procedure
  • treatment with botulinum toxin type A in the previous 4 months
  • any active device implant
  • any neurological disorder, other than stroke causing motor deficits or spasticity
  • inability to attend to and/or to cooperate with all outcome measure-related task secondary to cognitive impairment or aphasia
  • pregnancy, planned pregnancy, or lactation
  • contraindication to botulinum toxin type A

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Botulinum toxin type A injection

    Arm Description

    Botulinum toxin type A injection followed by functional electrical stimulation

    Outcomes

    Primary Outcome Measures

    Change in Box and Block test
    number of box moved by affected upper extremity
    Change of Action Research Arm Test
    Score of Action Research Arm Test

    Secondary Outcome Measures

    Muscle strength of finger extensor
    Medical research council grading of muscle strength
    Spasticity of finger extensor
    Modified ashworth scale of finger flexor
    active range of motion of wrist joint
    active range of motion of wrist joint
    Brunnstrom stage of stroke recovery of distal upper extremity
    Brunnstrom stage of stroke recovery of distal upper extremity. By observing the pattern of participants posture, the stage was scored. The stage ranges from 1 to 6. Higher is better.
    Distance from middle finger tip to mid-palmar crease
    Distance from middle finger tip to mid-palmar crease
    Repeated number of finger extension and flexion
    Repeated number of finger extension and flexion
    Quick Disabilities of Arm, Shoulder & Hand
    Quick Disabilities of Arm, Shoulder & Hand is questionnaire about patients' symptoms as well as ability to perform certain activities in the last week. Total score is obtained by summing the each question, and ranges from 0 (no disability) to 100 (most severe disability).
    Grading of active thumb opposition
    Grading of active thumb opposition. It is measured by observing the pattern of thumb opposition.
    Grip strength
    measured by Jamar dynamometer
    Active finger extension
    Active finger extension. It is graded by observation of voluntary finger extension.

    Full Information

    First Posted
    May 16, 2018
    Last Updated
    May 25, 2018
    Sponsor
    National Rehabilitation Center, Seoul, Korea
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03549975
    Brief Title
    Hand Rehabilitation Using Botulinum Toxin and Functional Electrical Stimulation-pilot Study
    Official Title
    Hand Rehabilitation Using Botulinum Toxin and Functional Electrical Stimulation Among Stroke Patients With Limitation of Finger Extension Due to Spasticity- Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    May 18, 2016 (Actual)
    Primary Completion Date
    August 18, 2017 (Actual)
    Study Completion Date
    August 18, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Rehabilitation Center, Seoul, Korea

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The investigator tried to find out possibility of functional improvement using botulinum toxin injection targeting finger flexor spasticity with functional electrical stimulation among chronic stroke patients who did not show any improvement in hand function.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Spastic Hemiparesis, Spasticity as Sequela of Stroke
    Keywords
    stroke, hand, botulinum toxin, functional electrical stimulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Botulinum toxin type A injection
    Arm Type
    Experimental
    Arm Description
    Botulinum toxin type A injection followed by functional electrical stimulation
    Intervention Type
    Drug
    Intervention Name(s)
    Botulinum Toxin Type A 100 unit/Vial (Product)
    Other Intervention Name(s)
    functional electrical stimulation
    Intervention Description
    Botulinum toxin type A injection followed by functional electrical stimulation
    Primary Outcome Measure Information:
    Title
    Change in Box and Block test
    Description
    number of box moved by affected upper extremity
    Time Frame
    baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
    Title
    Change of Action Research Arm Test
    Description
    Score of Action Research Arm Test
    Time Frame
    baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
    Secondary Outcome Measure Information:
    Title
    Muscle strength of finger extensor
    Description
    Medical research council grading of muscle strength
    Time Frame
    baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
    Title
    Spasticity of finger extensor
    Description
    Modified ashworth scale of finger flexor
    Time Frame
    baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
    Title
    active range of motion of wrist joint
    Description
    active range of motion of wrist joint
    Time Frame
    baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
    Title
    Brunnstrom stage of stroke recovery of distal upper extremity
    Description
    Brunnstrom stage of stroke recovery of distal upper extremity. By observing the pattern of participants posture, the stage was scored. The stage ranges from 1 to 6. Higher is better.
    Time Frame
    baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
    Title
    Distance from middle finger tip to mid-palmar crease
    Description
    Distance from middle finger tip to mid-palmar crease
    Time Frame
    baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
    Title
    Repeated number of finger extension and flexion
    Description
    Repeated number of finger extension and flexion
    Time Frame
    baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
    Title
    Quick Disabilities of Arm, Shoulder & Hand
    Description
    Quick Disabilities of Arm, Shoulder & Hand is questionnaire about patients' symptoms as well as ability to perform certain activities in the last week. Total score is obtained by summing the each question, and ranges from 0 (no disability) to 100 (most severe disability).
    Time Frame
    baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
    Title
    Grading of active thumb opposition
    Description
    Grading of active thumb opposition. It is measured by observing the pattern of thumb opposition.
    Time Frame
    baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
    Title
    Grip strength
    Description
    measured by Jamar dynamometer
    Time Frame
    baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
    Title
    Active finger extension
    Description
    Active finger extension. It is graded by observation of voluntary finger extension.
    Time Frame
    baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age over 18 years hemiplegic upper limb spasticity secondary to a unilateral ischemic or hemorrhagic stroke fingers and wrist flexor spasticity graded at least 1+ on the Modified Ashworth Scale at least 6 months since stroke Exclusion Criteria: fixed contracture previous treatment of the upper limb spasticity with neurolytic or surgical procedure treatment with botulinum toxin type A in the previous 4 months any active device implant any neurological disorder, other than stroke causing motor deficits or spasticity inability to attend to and/or to cooperate with all outcome measure-related task secondary to cognitive impairment or aphasia pregnancy, planned pregnancy, or lactation contraindication to botulinum toxin type A
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Joon-Ho Shin, MS
    Organizational Affiliation
    National Rehabilitation Center of Korea
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Hand Rehabilitation Using Botulinum Toxin and Functional Electrical Stimulation-pilot Study

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