Is it clinically effective to treat arm flexor spasticity, with Botulinum toxin - type A (BoNTA) and physiotherapy, as soon as signs of abnormal muscle activity are observed?

Phase 2

Completed

• Conditions: Topic: Stroke Research Network; Subtopic: Rehabilitation; Disease: Drug type; Circulatory System; Stroke

• Registration Number: ISRCTN57435427
• Lead Sponsor: Keele University (UK)

Brief Summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24401159

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-21
• Study Completion: 2014-12-31
• Last Update Posted: 1 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Over 18 years of age
2. Patients with stroke due to a primary cerebral haemorrhage/infarction, subarachnoid haemorrhage producing an upper motor syndrome affecting one body side which results in a hemiplegia
3. Capable of providing informed consent directly or indirectly, or, consent obtainable from next of kin or legal representative
4. No useful arm function (i.e. less than or equal to 2 on the grasp subsection of the Action Research Arm Test) at onset of spasticity.; Target Gender: Male & Female ; Lower Age Limit 18 years

Exclusion Criteria

1. Significant musculoskeletal conditions that affected upper limb function prior to the stroke
2. Unconscious or moribund during the screening perid
3. Recovery of useful arm function (a score of 3 or more in the grasp section of the Action Research Arm Test) prior to injections
4. Patients with contraindications to electrical stimulation including active implants (e.g. cardiac assist devices), metal implants at site of stimulation, scar tissue/cancerous tissue at site of stimulation, uncontrolled epilepsy, deep vein thrombosis in limb / muscle being stimulated and pregnancy (or planned pregnancy)
5. Previousupper motor neurone syndrome or hypertonicity due to multiple sclerosis, spinal cord injury or other neurological disorder
6. Patients with a known hypersensitivity to any botulinum toxin or to any of the excipients of BOTOX® (i.e. Human serum albumin)
7. Patients with myasthenia gravis or Eaton Lambert Syndrome or other neuromuscular junction or myopathic disorder
8. Patients with infection at the proposed injection site(s)
9. Patients who are pregnant or may become pregnant at the time of the proposed injections and for the duration of the study
10. Current treatment with any antispasticity agent or previous injection with BOTOX

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Action Research Arm Test; Timepoint(s): Baseline, 3 months and 6 months