3D-printed hand orthotics for the management of spasticity in cerebral palsy

Completed

• Conditions: Children diagnosed with cerebral palsy; Nervous System Diseases; Cerebral palsy

• Registration Number: ISRCTN11890421
• Lead Sponsor: Consejo Nacional de Ciencia, Tecnologia e Innovacion Tecnologica - CONCYTEC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-02
• Study Completion: 2018-02-07
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

This study will include children younger than 12 years with a diagnosis of spastic cerebral palsy who have a score of >1+ on the Ashworth scale. These criteria are applied because, at that age, children with cerebral palsy are at an age where there is a greater risk of suffering from deformities but also, they are preventable. Parents of children who meet the inclusion criteria should be able to understand the study objectives and not intend to move in the next 6 months. These criteria are applied as part of the information in the study will be obtained from the parents. If they are not able to understand the objectives of the study or plan to move, this will not allow adequate measurements or allow them to be attended in a timely manner in case of an emergency or adverse event.

Exclusion Criteria

This study will not include children who have undergone surgical intervention for the treatment of spasticity or who have indication for surgery to correct hand deformities. Neither will children who are currently receiving botulinum toxin for the treatment of spasticity or any other treatment for spasticity, including prior use of orthoses. The presence of allergic reactions to contact with orthotic material will also be considered as an exclusion criterion. These criteria are to be applied in order to ensure the orthoses effectiveness. If participants are already receiving some others treatments for spasticity, they will not require the use of orthoses. If during the study the participants require surgery or are prescribed the use of Botox, it will also be considered an exclusion criterion for the analysis of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Wrist passive range of movement, measured in angles using a goniometer at baseline and after four months

Secondary Outcome Measures

Name	Time	Method
1. Spasticity degree, measured using the Ashworth modified scale at baseline and after 4 months<br>2. Hand function, measured using the Manual Ability Classification System (MACS) in its Spanish version at baseline and after 4 months<br>3. Acceptability and usability of the 3D orthotics, assessed through interviews with parents after four months