Effectiveness of functional splinting combined with motor training to improve upper limb function in children with cerebral palsy and brain injury: A randomised controlled trial

Not Applicable

Completed

• Conditions: Hand function in children with neurological conditions; Neurological - Other neurological disorders

• Registration Number: ACTRN12613000690752
• Lead Sponsor: niversity of Notre Dame

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. Diagnosis of a Cerebral Palsy or a Brain Injury
2. Impaired upper limb function as a result of the neurological condition
3. Restricted wrist range of motion/position of wrist impacting on ability to use hand effectively
4. Therapy goals related to hand function

Exclusion Criteria

1. Manual Ability Classification Scale (MACS) level V (The MACS classifies a child's ability to use their hands for functional activities on a daily basis. MACS is a spectrum of I - V, with I being lest severe, and level V being most severe. Children who are classified as MACS level V require total assistance, and do not have the ability to actively use their hands for functionals tasks. Hence, in standard practice, these children would not be seen as candidates for the interventions being utilised in this study)

2. Known allergy to thermoplastic splinting material

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Canadian Occupational Performance Measure<br>[At baseline, 2 weeks after randomisation (following 2 week treatment block), at 10 weeks after randomisation<br>]

Secondary Outcome Measures

Name	Time	Method
The Goal Attainment Scale (GAS)[At baseline, 2 weeks after randomisation (following 2 week treatment block), at 10 weeks after randomisation];The Box & Blocks Test[At baseline, 2 weeks after randomisation (following 2 week treatment block), at 10 weeks after randomisation<br><br>Group 1 (splint only) and group 2 (motor training only) will complete the box and blocks test 1 hour following baseline to obtain data on the immediate effect of a functional hand splint, compared to no hand splint.];Active range of motion and passive range of motion of wrist extension (measurements to be taken with a digital inclinometer). This will include with fingers extended (Volkmann's angle)[At baseline, 2 weeks after randomisation (following 2 week treatment block), at 10 weeks after randomisation];House thumb classification collected at baseline only, to be used as initial participant data rather than an outcome measure.[At baseline only]