iWHOTrial (infant Wrist Hand Orthoses Trial): A multicentre randomized controlled trial of rigid wrist hand orthoses for young children with cerebral palsy.

Not Applicable

Active, not recruiting

• Conditions: Cerebral palsy or at risk of cerebral palsy; Neurological - Other neurological disorders

• Registration Number: ACTRN12614001275651
• Lead Sponsor: Christine Imms

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-05
• Last Update Posted: 3 October 2022

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

Diagnosis of, or identified as at risk of, cerebral palsy as reported in the child’s medical history. Every 6 months the diagnosis/risk of CP will be reviewed and at study exit a diagnosis of cerebral palsy needs to be confirmed by a medical specialist.
Aged 0-35 months on recruitment;
Presents with persistent abnormal flexion postures of the wrist +/- fingers +/- thumb;
Full passive range of movement in the wrist and hand;
Parents able to understand written and spoken English.

Exclusion Criteria

The presence of child and/or family factors, determined in consultation with the family, that identify upper limb orthoses wear as not clinically indicated;
Allergy/sensitivity to splinting material;
Family inability to access the study assessment or treatment site (due to geography).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Passive range of movement at the wrist (wrist extension) measured using standardised goniometric measurement. [Three years]