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

Not Applicable

Completed

• Conditions: Focal Hand Dystonia
• Interventions: Other: Botulinum toxin type A; Other: Task Specific Training

• Registration Number: NCT03664375
• Lead Sponsor: Isra University

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 Timeline

• Study Start: 2015-11
• Primary Completion: 2016-08
• Study Completion: 2016-12
• Status Verified: 2018-09
• Study First Submitted: 2018-09-05
• Study First Submitted QC: 2018-09-07
• Last Update Submitted: 2018-09-07
• Study First Posted: 2018-09-10
• Last Update Posted: 2018-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Task Specific Training	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.
Experimental Group	Botulinum toxin type A	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.
Control Group	Task Specific Training	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

Primary Outcome Measures

Name	Time	Method
WOLF MOTOR FUNCTION TEST (WMFT)	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."
MOTOR ASSESSMENT SCALE (MAS)	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.
FUGL- MEYER ASSESSMENT TEST	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
Action Research Arm Test (ARAT):	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.

Secondary Outcome Measures

Name	Time	Method
Severity Of Dystonia	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	12 weeks	The stroke specific Quality Of Life was administered to patients which rated their Quality of life