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

NCT ID: NCT03664375

Last Updated: 2018-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2016-12-31

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.

Conditions

Focal Hand Dystonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Botulinum toxin type A

Intervention Type: 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

Intervention Type: 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

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

Group Type: PLACEBO_COMPARATOR

Task Specific Training

Intervention Type: 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

Interventions

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.

Intervention Type: 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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Isra University

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Umar

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

IIRS-IUISB/PHD/008

Identifier Type: -

Identifier Source: org_study_id