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

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ClinicalTrials.gov Identifier: NCT03664375
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Muhammad Umar, Isra University

Tracking Information
First Submitted Date  ICMJE September 5, 2018
First Posted Date  ICMJE September 10, 2018
Last Update Posted Date September 10, 2018
Actual Study Start Date  ICMJE November 2015
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2018)
  • Action Research Arm Test (ARAT): [ Time Frame: 12 weeks ]
    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) [ Time Frame: 12 weeks ]
    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) [ Time Frame: 12 weeks ]
    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 [ Time Frame: 12 weeks ]
    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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2018)
  • Severity Of Dystonia [ Time Frame: 12 weeks ]
    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 [ Time Frame: 12 weeks ]
    The stroke specific Quality Of Life was administered to patients which rated their Quality of life
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact Of Physiotherapy And Botox In Improving Functional Outcomes Among Post Stroke Focal Dystonia Patients
Official Title  ICMJE Impact Of Physiotherapy And Botulinum Toxin Type-A In Improving Functional Outcomes In Upper Limb Focal Dystonia Among Post Stroke Patients
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Condition  ICMJE Focal Hand Dystonia
Intervention  ICMJE
  • Other: Botulinum toxin type A
    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.
  • Other: Task Specific Training
    Task specific training is the repetition of a specific task until expertise is reached. More challenging tasks are added as a means of progression
Study Arms  ICMJE
  • Experimental: Experimental Group
    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.
    Interventions:
    • Other: Botulinum toxin type A
    • Other: Task Specific Training
  • Placebo Comparator: Control Group
    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: Other: Task Specific Training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 7, 2018)
39
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03664375
Other Study ID Numbers  ICMJE IIRS-IUISB/PHD/008
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Responsible Party Muhammad Umar, Isra University
Study Sponsor  ICMJE Isra University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Isra University
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP