Clinical Trial: RCT on Interactive Computer Play on Trunk Control in CP

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Effectiveness of Interactive Computer Play on Trunk Control and Gross Motor Function in Children With Cerebral Palsy: a Pilot Randomized Controlled Trial

Brief 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 88 (GMFM 88)
  • 2-minute walk test

Data analysis:

As a

Detailed Summary:

Cerebral palsy (CP) is the most common physical disabilities in childhood, affecting 2 to 2.5 per 1000 live-births worldwide and about 1.3 per 1000 live-births in Hong Kong. It is a non-progressive lesion of the developing central nervous system affecting the control of movements and postures in the children. Children with CP are usually classified using the Gross Motor Function Classification System (GMFCS) according to age-specific gross motor functional abilities and reliance on assistive devices (such as walking aids or wheeled mobility). It is an ordinal grading system of five levels (I to V), in which self-initiated movements, such as sitting, standing or walking, are described in relation to different age groups. Children of levels I and II can generally walk without aids while children of level III can walk with aids for short distances but usually choose wheeled mobility in community settings. Children at level IV have limited motor ability in assisted standing, stepping, and transfers. Children classified as level V are completely dependent for transportation in a wheelchair and lack antigravity postural control. Numerous studies have shown that children with CP, regardless their GMFCS levels, demonstrate problems in their postural control in sitting and standing, which in turn affect their function and participation in daily life. The main deficits in postural control in sitting for children with CP are lack of ability to recruit direction-specific muscles in more severe children (GMFCS levels IV and V) or inability to fine-tune the degree of muscle contraction according to specific situations. Excessive contraction of antagonists is a common compensatory strategy. These ineffective strategies to compensate their balance in sitting or standing positions will affect the children's daily function such as desk work at school, transfers and ambulation.

Postural con
Sponsor: The Hong Kong Polytechnic University

Current Primary Outcome:

  • Segmental Assessment on Trunk control-static [ Time Frame: 12 weeks ]
    assess the level of static segmental trunk control
  • Segmental Assessment on Trunk control-active [ Time Frame: 12 weeks ]
    assess the level of active segmental trunk control
  • Segmental Assessment on Trunk control-reactive [ Time Frame: 12 weeks ]
    assess the level of reactive segmental trunk control


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pediatric Reach Test-forward sitting [ Time Frame: 12 weeks ]
    assess how far the child can reach forward in sitting
  • Pediatric Reach Test- right sitting [ Time Frame: 12 weeks ]
    assess how far the child can reach to his/her right in sitting
  • Pediatric Reach Test- left sitting [ Time Frame: 12 weeks ]
    assess how far the child can reach to his/her left in sitting
  • Pediatric Reach Test- forward standing [ Time Frame: 12 weeks ]
    assess how far the child can reach forward in standing
  • Pediatric Reach Test- right standing [ Time Frame: 12 weeks ]
    assess how far the child can reach to his/her right in standing
  • Pediatric Reach Test- left standing [ Time Frame: 12 weeks ]
    assess how far the child can reach to his/her left in standing
  • Gross Motor Function Measure 88- lying [ Time Frame: 12 weeks ]
    assess the gross motor function in Lying and Rolling dimension
  • Gross Motor Function Measure 88- sitting [ Time Frame: 12 weeks ]
    assess the gross motor function in Sitting dimension
  • Gross Motor Function Measure 88- crawling [ Time Frame: 12 weeks ]
    assess the gross motor function in Crawling and Kneeling dimension
  • Gross Motor Function Measure 88- standing [ Time Frame: 12 weeks ]
    assess the gross motor function in Standing dimension
  • Gross Motor Function Measure 88- walking [ Time Frame: 12 weeks ]
    assess the gross motor function in Walking, Running and Jumping dimension
  • 2-minute walk test [ Time Frame: 12 weeks ]
    measure how far the study participant can walk in 2 minutes in metres
  • Height [ Time Frame: 12 weeks ]
    measure the height of study participants in centimetres
  • Weight [ Time Frame: 12 weeks ]
    measure the body weight of study participants in kilograms


Original Secondary Outcome: Same as current

Information By: The Hong Kong Polytechnic University

Dates:
Date Received: November 24, 2016
Date Started: February 2017
Date Completion: August 2018
Last Updated: November 24, 2016
Last Verified: November 2016