Clinical trial NCT03664375: Impact Of Physiotherapy And Botox In Improving Functional Outcomes Among Post Stroke Focal Dystonia Patients
Official title: Impact Of Physiotherapy And Botulinum Toxin Type-A In Improving Functional Outcomes In Upper Limb Focal Dystonia Among Post Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Focal Hand Dystonia
Keywords: Dystonia Task-specific training Botulinum toxin type A
Lead sponsor: Isra University
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 46 patients were recruited in the study using non-probability purposive sampling and were divided randomly into two equal groups; control and experimental group, by sealed envelope method. The experimental group received botulinum toxin A followed by task specific training, while the control group received only task-specific training for 12 weeks. Data was collected at baseline, after 4 weeks, 8 weeks and 12 weeks by using upper extremity items of Motor Assessment Scale and Fugl Meyer Assessment scale of upper limb, Stroke specific quality of Life, Arm dystonia Disability scale and WOLF Motor function test.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Action Research Arm Test (ARAT):
timeFrame: 12 weeks
measure: MOTOR ASSESSMENT SCALE (MAS)
timeFrame: 12 weeks
measure: WOLF MOTOR FUNCTION TEST (WMFT)
timeFrame: 12 weeks
measure: FUGL- MEYER ASSESSMENT TEST
timeFrame: 12 weeks
Secondary outcomes:
measure: Severity Of Dystonia
timeFrame: 12 weeks
measure: Stroke Specific Quality Of Life
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References: