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Impact Of Physiotherapy And Botox In Improving Functional Outcomes Among Post Stroke Focal Dystonia Patients

Primary Purpose

Focal Hand Dystonia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Botulinum toxin type A
Task Specific Training
Sponsored by
Isra University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Focal Hand Dystonia focused on measuring Dystonia Task-specific training Botulinum toxin type A

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients having first episode of unilateral stroke
  • At least 6 months of post stroke duration presenting with post stroke focal dystonia of the upper limb.
  • No previous exposure of the affected hand of Botox.
  • Reduced upper limb functions
  • Both genders will be included equally.

Exclusion Criteria:

  • Significant speech or cognitive impairment which impedes the ability to perform the assessment.
  • Other significant upper limb impairment e.g. fracture or frozen shoulder within 6 months.
  • Severe arthritis, amputation, evidence of fixed contracture, pregnancy or lactating womens.
  • Other diagnosis likely to interfere with rehabilitation or outcome assessments, e.g. blind, malignancy,
  • Other conditions which may contribute to upper limb spasticity, e.g. multiple sclerosis, cerebral palsy.
  • Use of botulinum toxin to the upper limb in the previous 4 months.
  • Contraindications to intramuscular injection.
  • Contraindications /allergy to botulinum toxin type A, which include bleeding disorders, myasthenia gravis and concurrent use of aminoglycosides.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Experimental Group

    Control Group

    Arm Description

    The experimental group received botulinum toxin type A. After one week of Botox administration, a specially made task specific training program was started for these patients. It was provided for a duration of one hour and for three times per week for a total of 12 weeks by a trained physiotherapist.

    The control group received only task specific training program with the same protocol as for the experimental group; for a duration of one hour and for three times per week up to a total of 12 weeks by a trained physiotherapist

    Outcomes

    Primary Outcome Measures

    Action Research Arm Test (ARAT):
    It assessed specific changes in limb function by 19 items grouped in four subscales. The total score ranged from 0 to 57. The lower score indicated no movement and upper score indicated normal performance of the patient.
    MOTOR ASSESSMENT SCALE (MAS)
    It was a performance-based scale, based on a task-oriented approach to evaluate and assesses performance of functional tasks rather than isolated patterns of movement. All items were assessed using a 7-point scale from 0 - 6. A score of 6 indicated optimal motor behavior.
    WOLF MOTOR FUNCTION TEST (WMFT)
    It quantified motor ability through timed functional tasks. It used a 6-point ordinal scale with "0" = "does not attempt with the involved arm" to "5" = movement appears to be normal."
    FUGL- MEYER ASSESSMENT TEST
    It was a performance-based impairment index to measure motor functioning. The total score possible was from 0 - 66, with higher function showing the improved level of independence

    Secondary Outcome Measures

    Severity Of Dystonia
    The Arm Dystonia Disability Scale: The severity of dystonia was assessed using 0 (None) to 3 (Marked Difficulty in performing activity
    Stroke Specific Quality Of Life
    The stroke specific Quality Of Life was administered to patients which rated their Quality of life

    Full Information

    First Posted
    September 5, 2018
    Last Updated
    September 7, 2018
    Sponsor
    Isra University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03664375
    Brief Title
    Impact Of Physiotherapy And Botox In Improving Functional Outcomes Among Post Stroke Focal Dystonia Patients
    Official Title
    Impact Of Physiotherapy And Botulinum Toxin Type-A In Improving Functional Outcomes In Upper Limb Focal Dystonia Among Post Stroke Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2015 (Actual)
    Primary Completion Date
    August 2016 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Isra University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study was conducted to assess the combine role of Physiotherapy by providing task specific trainings and Botulinum Toxin Type A in improving the functional outcomes of upper limb in post stroke patients with focal hand dystonia.
    Detailed Description
    Post-stroke hemiparesis, with dystonia, is a major cause of disability. Dystonia can hinder the functional activities making patient dependent on others for performance of daily living activities. Dystonia not only limits the physical activity of the patient but also affects their quality of life significantly. Various treatment protocols have been used in the literature for treatment of focal hand dystonia in the past including deep brain stimulation, kinesio taping, sensory oriented training, splinting, extracorporeal shock wave therapy and botox. Out of these Botox has gained much importance but it results only in improving the passive range of motion and has no consensus in improving the active range of motion and functional independence of the patient. The current study was planned to determine the effects of botulinum toxin type A combined with task-specific therapy, for post-stroke focal dystonia of upper limb.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Focal Hand Dystonia
    Keywords
    Dystonia Task-specific training Botulinum toxin type A

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    A total of 46 patients were recruited in the study using non-probability purposive sampling and were divided randomly into two equal groups; control and experimental group, by sealed envelope method. The experimental group received botulinum toxin A followed by task specific training, while the control group received only task-specific training for 12 weeks. Data was collected at baseline, after 4 weeks, 8 weeks and 12 weeks by using upper extremity items of Motor Assessment Scale and Fugl Meyer Assessment scale of upper limb, Stroke specific quality of Life, Arm dystonia Disability scale and WOLF Motor function test.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    39 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental Group
    Arm Type
    Experimental
    Arm Description
    The experimental group received botulinum toxin type A. After one week of Botox administration, a specially made task specific training program was started for these patients. It was provided for a duration of one hour and for three times per week for a total of 12 weeks by a trained physiotherapist.
    Arm Title
    Control Group
    Arm Type
    Placebo Comparator
    Arm Description
    The control group received only task specific training program with the same protocol as for the experimental group; for a duration of one hour and for three times per week up to a total of 12 weeks by a trained physiotherapist
    Intervention Type
    Other
    Intervention Name(s)
    Botulinum toxin type A
    Intervention Description
    All patients in the experimental group received a BoNT-A injection. The injected total dose for individual patient in the experimental group was 100 units which is equivalent to approximately 300-500 Units of Dysport (the other type of BoNT-A available). The Botox was injected by the neurophysician intramuscularly using insulin U100 syringe and determination of muscles for injection was assessed clinically.
    Intervention Type
    Other
    Intervention Name(s)
    Task Specific Training
    Intervention Description
    Task specific training is the repetition of a specific task until expertise is reached. More challenging tasks are added as a means of progression
    Primary Outcome Measure Information:
    Title
    Action Research Arm Test (ARAT):
    Description
    It assessed specific changes in limb function by 19 items grouped in four subscales. The total score ranged from 0 to 57. The lower score indicated no movement and upper score indicated normal performance of the patient.
    Time Frame
    12 weeks
    Title
    MOTOR ASSESSMENT SCALE (MAS)
    Description
    It was a performance-based scale, based on a task-oriented approach to evaluate and assesses performance of functional tasks rather than isolated patterns of movement. All items were assessed using a 7-point scale from 0 - 6. A score of 6 indicated optimal motor behavior.
    Time Frame
    12 weeks
    Title
    WOLF MOTOR FUNCTION TEST (WMFT)
    Description
    It quantified motor ability through timed functional tasks. It used a 6-point ordinal scale with "0" = "does not attempt with the involved arm" to "5" = movement appears to be normal."
    Time Frame
    12 weeks
    Title
    FUGL- MEYER ASSESSMENT TEST
    Description
    It was a performance-based impairment index to measure motor functioning. The total score possible was from 0 - 66, with higher function showing the improved level of independence
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Severity Of Dystonia
    Description
    The Arm Dystonia Disability Scale: The severity of dystonia was assessed using 0 (None) to 3 (Marked Difficulty in performing activity
    Time Frame
    12 weeks
    Title
    Stroke Specific Quality Of Life
    Description
    The stroke specific Quality Of Life was administered to patients which rated their Quality of life
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients having first episode of unilateral stroke At least 6 months of post stroke duration presenting with post stroke focal dystonia of the upper limb. No previous exposure of the affected hand of Botox. Reduced upper limb functions Both genders will be included equally. Exclusion Criteria: Significant speech or cognitive impairment which impedes the ability to perform the assessment. Other significant upper limb impairment e.g. fracture or frozen shoulder within 6 months. Severe arthritis, amputation, evidence of fixed contracture, pregnancy or lactating womens. Other diagnosis likely to interfere with rehabilitation or outcome assessments, e.g. blind, malignancy, Other conditions which may contribute to upper limb spasticity, e.g. multiple sclerosis, cerebral palsy. Use of botulinum toxin to the upper limb in the previous 4 months. Contraindications to intramuscular injection. Contraindications /allergy to botulinum toxin type A, which include bleeding disorders, myasthenia gravis and concurrent use of aminoglycosides.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

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