Trial | NCT03664375  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    39
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.
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 Started
Nov 30
2015
Primary Completion
Aug 31
2016
Study Completion
Dec 31
2016
Last Update
Sep 10
2018

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

Experimental Group Experimental

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 Placebo Comparator

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

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.
No Results Posted