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

Isra University

Status: Completed

Conditions: Focal Hand Dystonia

Treatments: Other: Task Specific Training; Other: Botulinum toxin type A

Study type: Interventional

Funder types: Other

Identifiers

NCT03664375

IIRS-IUISB/PHD/008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 2 patient groups, including a placebo group

Experimental Group

Experimental group

Description:

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.

Treatment:

Other: Task Specific Training

Other: Botulinum toxin type A

Control Group

Placebo Comparator group

Description:

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

Treatment:

Other: Task Specific Training