The effectiveness of best practise therapy after Botulinum Toxin A injections for adults diagnosed with neurological impairment and onset of spasticity.

Phase 4

Completed

• Conditions: Stroke; Acquired Brain Injury; Spasticity; Stroke - Ischaemic; Stroke - Haemorrhagic; Neurological - Other neurological disorders

• Registration Number: ACTRN12612000091808
• Lead Sponsor: Associate Professor Natasha Lannin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Diagnosis of neurological injury (including stroke and brain injury) and onset of spasticity in at least one limb

Minimum of one month post-neurological injury

Score of 21 or greater on the Mini-Mental State Examination (Folstein, Folstein and McHugh, 1975) as an indicator of sufficient cognitive ability to participate in the therapy program

Exclusion Criteria

a. Significant speech or cognitive impairment which impedes ability to perform assessments.
b.Other significant upper limb impairment eg. Fracture or frozen shoulder within 6 months, severe arthritis, amputation.
c.Pregnancy or lactating/ or at risk of pregnancy and not willing to take adequate precautions against pregnancy for the duration of their involvement in the trial.
d.Presence of contraindications to intramuscular injections.
e.Presence of any and all contraindications to botulinum toxin-A which include bleeding disorders, myasthenia gravis and concurrent use of aminoglycosides.
f.Use of botulinum toxin to the limb in previous five months
g.Known allergy or hypersensitivity to any of the test compounds.
h.Previous enrolment in the study (participants may only enrol in the study for one dose of therapy via the trial).

Study & Design

• Study Type: Interventional
• Study Design: Not specified