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

NCT03664375 | Completed DMC

• 1 other identifier: IIRS-IUISB/PHD/008
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Focal Hand Dystonia

Keywords

Dystonia Task-specific training Botulinum toxin type A

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (2)

• Severity Of Dystonia

  12 weeks

• Stroke Specific Quality Of Life

  12 weeks

Study Arms (2)

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.

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

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

Other: Task Specific Training

Interventions

Botulinum toxin type A 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.

Experimental Group

Task Specific Training 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; Experimental Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Isra University: lead

MeSH Terms

Conditions

Dystonia, Focal, Task-Specific

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 10, 2018
• Study Start: November 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 10, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR