RCT on Interactive Computer Play on Trunk Control in CP

Summary

Objectives:

This proposal is to investigate the effect of a 6-week training programme using an Interactive computer play (ICP) on the trunk control, balance and gross motor function in children with cerebral palsy (CP).

Hypothesis to be tested:

The trunk control, balance and gross motor function of children with CP will be significantly improved after the ICP programme.

Design and subjects:

20 children (6 to 12 years old) with CP will be recruited in this pilot randomised controlled trial. The children will be randomly allocated into a control or treatment group (10 children in each arm).

Study instruments:

Tymo is a wireless force plate used for assessment and training.

Intervention:

An ICP program will be set up using the Tymo. The child uses their trunk movements in the ICP in sitting during the intervention. The children will receive the intervention 4 times/week, 20 minutes/session for 6 weeks. All children will be assessed at the beginning, 3, 6 and 12 weeks post-intervention.

Main outcome measures:

* Segmental Assessment on Trunk control
* Pediatric Reach Test
* Gross Motor Function Measure Item Set (GMFM IS)
* 2-minute walk test

Data analysis:

As a pilot study, 20 children will be recruited for this study. Independent t-test or Mann Whitney U test will be used to compare the continuous and ordinal results between the intervention and control groups.

Expected results:

The trunk control, balance and gross motor function of children with CP will be significantly improved after the intervention.

Clinical significance and potential of the study:

This is clinical trial to examine the effectiveness of a new intervention, a kind of interactive computer play training module, on training the trunk control for children with cerebral palsy. If the intervention is proven effective, it may be an adjunct to the conventional Physiotherapy to children with movement disorders in enhancing their trunk control. Better trunk control will in turn improve the daily function for these children as their sitting and standing balance is improved. In a long run, these children will not rely on expensive seating equipment to maintain their balance during schooling and at home.

Conditions

• Cerebral Palsy
• Exercise Therapy
• Postural Balance

Interventions

DEVICE

Tymo

All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game.

Sponsors & Collaborators

• Manchester Metropolitan University

  collaborator OTHER

• The Hong Kong Polytechnic University

  lead OTHER

Principal Investigators

• Tamis W Pin, PhD · Hong Kong Polytechnic University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-01

Primary Completion

2018-09-30

Completion

2018-09-30

Countries

• Hong Kong

Study Locations