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

Focal Hand Dystonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03664375
• Other study ID #: IIRS-IUISB/PHD/008
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: December 2016

Study information

• Verified date: September 2018
• Source: Isra University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dystonia
• Dystonic Disorders
• Focal Hand Dystonia

Intervention

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.
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Isra University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Primary	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.	12 weeks
Primary	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."	12 weeks
Primary	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	12 weeks
Secondary	Severity Of Dystonia	The Arm Dystonia Disability Scale: The severity of dystonia was assessed using 0 (None) to 3 (Marked Difficulty in performing activity	12 weeks
Secondary	Stroke Specific Quality Of Life	The stroke specific Quality Of Life was administered to patients which rated their Quality of life	12 weeks