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Completed

NCT Number: NCT03664375

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

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.

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Key information

Conditions

Focal Hand Dystonia Dystonia, Focal, Task-Specific

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

botulinum toxin type A

Other

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.

Task specific Training

Other

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 outcomes

  1. 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.

  2. 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.

  3. 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."

  4. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Isra University

Other

Registry information

Official study title

Impact Of Physiotherapy And Botulinum Toxin Type-A In Improving Functional Outcomes In Upper Limb Focal Dystonia Among Post Stroke Patients

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 10, 2018
Registry last updated
Sep 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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