A randomised controlled trial to evaluate the effect of modified constraint induced movement therapy or conventional occupational therapy following injection of botulinum toxin-A to improve bimanual performance in children with hemiplegic cerebral palsy.

Completed

• Conditions: Hemiplegic Cerebral Palsy; Neurological - Other neurological disorders; Physical Medicine / Rehabilitation - Occupational therapy

• Registration Number: ACTRN12605000002684
• Lead Sponsor: Southern Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-07-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Diagnosis of spastic hemiplegic cerebral palsy; activie movement of the shoulder, elbow, wrist, digits and thumb; able to grasp a 1 inch cube from a table top and release it into a large container; ability to attend to tasks and follow simple one stage commands; moderate levels of muscle tone and spasticity; no fixed contracture in target group of muscles to be injected with Botulinum toxin-A.

Exclusion Criteria

Previous Botulinum toxin-A injections in the upper limb in the past twelve months; prior upper limb surgery (ie. tendon transfer/tendon lengthening); families do not agree to cease all other alternative upper limb therapies.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bimanual performance (Assisting Hand Assessment)[At baseline, 1 month, 3 months and 6 months post Boutlinum toxin injection]

Secondary Outcome Measures

Name	Time	Method
Quality of Movement - Quality of Upper Extremity Skills Test (QUEST).[At baseline, 1 month, 3 months and 6 months post Boutlinum toxin injection.];Spasticity - modified Tardieu scale Muscle tone - modified Ashworth scale Passive Range of Movement - Goniometry.[At baseline, 1 month, 3 months and 6 months post Boutlinum toxin injection.];Caregiver Assistance[At baseline, 1 month, 3 months and 6 months post Boutlinum toxin injection.];Pediatric Evaluation of Disability Index (PEDI) Frequency of Use - Pediatric Motor Activity Log (PMAL).[At baseline, 1 month, 3 months and 6 months post Boutlinum toxin injection.];Individual Goal Setting[At baseline, 1 month, 3 months and 6 months post Boutlinum toxin injection.];Canadian Occupational Performance Measure (COPM) & Goal Attainment Scaling (GAS).[At baseline, 1 month, 3 months and 6 months post Boutlinum toxin injection.]