RCT on Interactive Computer Play on Trunk Control in CP
Condition: Cerebral Palsy; Exercise Therapy; Postural Balance
MeSH terms: Cerebral Palsy
Study type: Interventional

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.
    

Detailed description: 
      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 control involves controlling the body's position in space for stability and
      motility. Good postural control around the trunk or 'trunk control' in short, allows an
      individual to perform different tasks in an upright and vertical posture without losing the
      balance. The control of trunk to maintain balance in either sitting or standing positions is
      usually tested in the following three conditions: static balance, anticipatory balance and
      reactive balance. Assessment of trunk control in children is commonly part of a motor
      assessment such as Bruininks-Osteretsky Test of Motor Proficiency. The main limitation of
      these motor assessments is that the trunk is considered a one unit during a motor act,
      despite that there are different segments in the spine. Preliminary findings in very young
      infants have shown that infants with lumbar control had better movement quality in reaching
      actions when compared to those with thoracic control only. It seems that specific outcome
      measures on trunk control are necessary to demonstrate improvement in movement quality like
      this. There are specific outcome measures assessing balance, an indication of trunk control
      in recovering stability after internal or external perturbations such as Pediatric Reach Test
      (PRT), Pediatric Balance Scale, and Segmental Assessment on Trunk control (SATCo). It has
      been found very few of the commonly used outcome measures on balance have covered assessing
      all three aspects of balance as mentioned above. Most of these outcome measures require the
      children to be able to sit independently with or without hand support, making it unsuitable
      for children with CP of GMFCS levels IV and V. Furthermore, most of these outcome measures
      have the same limitation in considering the trunk as one whole unit, not consisting of
      different regions. Among all the commonly used assessment of trunk control, SATCo is a
      recently refined assessment on segmental trunk control in children. The child's trunk control
      is examined by progressively reducing the trunk support from the shoulder girdle to the
      pelvis in order to assess the head control, upper thoracic, mid-thoracic, lower thoracic,
      upper lumbar, lower lumbar and full trunk control. The trunk control is tested under 3
      different conditions in sitting: to maintain the posture (static control), during voluntary
      head movements (active control) and recovery of trunk control after a disturbance of balance
      by a nudge (reactive control). (Butler et al, 2010) The preliminary results of the SATCo
      showed a high inter-rater reliability (ICC ≥ 0.8) and moderate to good correlations with
      other established motor assessments (r from 0.65 to 0.88). Besides assessing the trunk in
      different segments, SATCO is one of the rare ones being able to assess reactive balance. It
      has been recommended that to increase the comprehensiveness in assessing the balance
      mechanism in children with CP, researchers can use the SATCo in combination of outcome
      measures assessing more dynamic sitting balance, such as the PRT.

      Interactive computer play (ICP) has become popular in rehabilitation for people with motor
      impairments, including children with CP. During an ICP, a child interacts and plays with
      virtual objects in a computer-generated environment, through the use of a computer console or
      platform and the software, allowing the child to control the games through certain body
      movements. Because the computer games are fun and enjoyable, the child will repeat the
      required body movements in numerous times so as to get a high score in the game without
      losing the interest. These numerous repetitions (essentially mass practice) and feedback from
      the game scores (knowledge of performance and results) are important in motor learning and
      enhancing neuroplasticity. Hence, ICP may be a feasible way to improve trunk control in
      children with CP, in addition to the conventional therapies. Up to date, there are six
      published studies using ICP or virtual reality in improving balance in children with CP..
      From these 6 published studies, promising though conflicting results were found whether ICP
      is effective in improving trunk control in children with CP. The main limitations of these
      studies are the overall low levels of study quality, small sample sizes and heterogeneous
      population groups under the umbrella term CP. In fact, similar conclusions for future studies
      with larger sample sizes and rigorous study designs have been echoed from the four recent
      systematic reviews on the topic.

      One of possible reasons for the conflicting conclusion on the use of ICP in rehabilitation
      for children with CP may be lack of sensitive outcome measures to capture the specific
      changes in the trunk control post-intervention. The above-mentioned studies were either using
      general motor assessments or outcome measures with unknown psychometric properties to assess
      the posture of the participants. Besides, when the child received the ICP intervention in a
      standing position, compensatory strategies, due to uncontrolled degrees of freedom in lower
      limbs, might be used to maintain their trunk control in this more challenging position than a
      sitting position. These compensatory strategies may in turn, water down the overall effect of
      the ICP intervention on the trunk control. Most of these studies examined only one or two
      aspect of the trunk control as testing the static or anticipatory balance of the children.
      The commercial gaming consoles, such as Nintendo Wii Fit, are not specifically developed for
      children with CP to elicit targeted movements to overcome their impairment and the software
      may not be sensitive enough to translate the subtle movement changes to an increase in the
      game scores as well to an adequate challenge for these children.

      Tymo (Tyromotion, Austria, www.tyromotion.com) is a wireless force plate detecting the
      movement of the centre of pressure, either in a sitting or standing position. Force and
      weight distribution can be measured using the software provided with the Tymo in these two
      positions. During the assessment, the user will move the trunk forward, backward and sideways
      as far as they can. The amplitude of the force and weight distribution between the two sides
      of the body will be recorded. This information will be used when the user uses the Tymo as a
      balance training module, in which the user will move the trunk forward, backward and sideways
      to participate in a computer game. For example, the user will move their trunk in different
      directions so as to manoeuvre a basket to catch the falling apples. The difficulties of the
      game will be adjusted according to the information provided during the assessment so that the
      user needs to move their body accordingly in different directions without losing their
      balance. This equipment is specially designed for rehabilitation for people with movement
      disorders, hence unlike the commercial games, there are no flashing lights or sudden noises
      during the games.

      20 children with CP or similar physical disabilities will be recruited from 2 special schools
      for children with physical disabilities in Hong Kong. Informed consent will be sought from
      the parents or guardians before the study will commence. After the initial assessment, all
      study children will be randomly allocated into a control group or treatment group (10
      children in each arm) using a 'draw card from the hat'. The randomization will be separately
      done in each school. The children in the treatment group will receive training on their trunk
      control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment
      will last for 6 weeks. All study children will continue their usual therapies at school but
      will be asked to stop playing any interactive computer play, which is designed to train
      balance such as Nintendo Wii balance board, during the study period. As there is no strong
      research evidence that commercial computer games are effective in improving the balance for
      children with CP and this type of commercial computer play is not a routine training
      exercises for balance at the schools, it is believed that discontinuing this type of
      'training' for 6 weeks would not cause detrimental effect on the balance of the study
      children.

      All the assessment will be carried out by a blinded assessor, who is not aware of the group
      allocation of the children. All the children will be assessed at the beginning, and 3, 6 and
      12 weeks after the commencement of the intervention.

      All children will be calibrated using the Tymo in a static sitting position in each treatment
      session by the research staff and 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. The child will have a maximal choice of 2 computer games in each treatment
      session. All children will start at a medium level of difficulty. Only if the child is unable
      to score any point in 3 trials in a row, the difficulty level will be reduced to one level
      down. Similarly, if the child scores full points in 3 trials in a row, the difficulty level
      will be increased to one level up. The progression of the intervention will then be closely
      monitored by the research staff. A logbook will be used for each child to record the level of
      difficulty in each treatment session, the number of treatment sessions, duration of each
      session and general comments on the child in each session during the intervention phase by a
      research assistant.
    

Intervention name(s): Tymo
Intervention type(s): Device
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: cerebral palsy; video games; postural control; balance; children