Cerebral PalsyNCT02975804
RCT on Interactive Computer Play on Trunk Control in CP
A study testing Tymo in people with Cerebral Palsy and Exercise Therapy, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy, Exercise Therapy, Postural Balance
- What is being tested?
- Tymo
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2017to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with a diagnosis of CP will be of GMFCS levels III to IV, who in general, require walking aid (level III) during ambulation and with limited walking ability (level IV).[4] Aiming to achieve a higher homogeneity of the recruited children, for those with level III, only those requiring physical assistance to climb stairs will be recruited and so it is believed that only those with lower motor ability, i.e. similar to level IV, will be included.
- Children, with non-CP physical disabilities, will have similar gross motor function as in (1).
- Aged from 6 to 12 years old and
- Able to follow instructions to interact in simple computer games
Who cannot join
- Children with epilepsy/ seizures that could be elicited by flashing lights or sudden loud noises from computer screens
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Interactive Computer Play on Trunk Control and Gross Motor Function in Children With Cerebral Palsy: a Pilot Randomized Controlled Trial
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).
Read more
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.
Read the 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.
- Conditions
- Cerebral Palsy, Exercise Therapy, Postural Balance
- Being tested
- Tymo
- Keywords
- cerebral palsy, video games, postural control, balance, children
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TymoDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Interactive computer play (ICP) | Experimental | 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. Receives: Device: Tymo |
| Standard Therapy | No intervention | Children in the control group will continue their usual therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Segmental Assessment on Trunk Control-static
assess the level of static segmental trunk control. Assessment score represents as follows: 1= learning head control, 2= learning upper thoracic control, 3= learning mid-thoracic control, 4= learning lower thoracic control, 5= learning at upper lumber control, 6= learning lower lumbar control, 7= learning full trunk control and 8= achieved full trunk control.
Measured: 12 weeks
Segmental Assessment on Trunk Control-active
assess the level of active segmental trunk control. Assessment score represents as follows: 1= learning head control, 2= learning upper thoracic control, 3= learning mid-thoracic control, 4= learning lower thoracic control, 5= learning at upper lumber control, 6= learning lower lumbar control, 7= learning full trunk control and 8= achieved full trunk control.
Measured: 12 weeks
Segmental Assessment on Trunk Control-reactive
assess the level of reactive segmental trunk control. Assessment score represents as follows: 1= learning head control, 2= learning upper thoracic control, 3= learning mid-thoracic control, 4= learning lower thoracic control, 5= learning at upper lumber control, 6= learning lower lumbar control, 7= learning full trunk control and 8= achieved full trunk control.
Measured: 12 weeks
Secondary outcomes (14)
Pediatric Reach Test-forward Sitting
assess how far the child can reach forward in sitting
Measured: 12 weeks
Pediatric Reach Test- Right Sitting
assess how far the child can reach to his/her right in sitting
Measured: 12 weeks
Pediatric Reach Test- Left Sitting
assess how far the child can reach to his/her left in sitting
Measured: 12 weeks
Pediatric Reach Test- Forward Standing
assess how far the child can reach forward in standing
Measured: 12 weeks
Pediatric Reach Test- Right Standing
assess how far the child can reach to his/her right in standing
Measured: 12 weeks
Pediatric Reach Test- Left Standing
assess how far the child can reach to his/her left in standing
Measured: 12 weeks
Gross Motor Function Measure Item Set- Total Score
assess the gross motor function using Gross Motor Function Measure Item Set.There are 4 Item Sets: Item Set 1 includes 15 test items (score ranged from 0 to 45), Item Set 2 including 29 items (score ranged from 0 to 87), Item Set 3 including 39 items (score ranged from 0 to 117) and Item Set 4 including 22 test items (score ranged from 0 to 66). Each participant will only be assessed with 1 Item Set based on their score on pre-defined decision items (Russell et al.Gross Motor Function Measure (GMFM-66 \& GMFM-88) User's manual 2nd Edition. 2013). Individual item scores of the Item Set are entered and a mathematical algorithm calculates an interval level total score ranged from 0 to 100) using the Gross Motor Ability Estimator (GMAE-2) Scoring Software (https://www.canchild.ca/en/resources/191-gross-motor-ability-estimator-gmae-2-scoring-software-for-the-gmfm). The higher scores mean higher abilities.
Measured: 12 weeks
2-minute Walk Test
measure how far the study participant can walk in 2 minutes in metres
Measured: 12 weeks
Height
measure the height of study participants in centimetres
Measured: 12 weeks
Weight
measure the body weight of study participants in kilograms
Measured: 12 weeks
Gross Motor Function Measure 88- Lying
assess the gross motor function in lying and rolling using Gross Motor Function Measure 88-lying (score ranged from 0 to 51) where higher score means higher gross motor function in this position.
Measured: 12 weeks
Gross Motor Function Measure 88- Sitting
assess the gross motor function inlsitting using Gross Motor Function Measure 88-sitting (score ranged from 0 to 60) where higher score means higher gross motor function in this position.
Measured: 12 weeks
Gross Motor Function Measure 88- Crawling and Kneeling
assess the gross motor function in crawling position using Gross Motor Function Measure 88-crawling and kneeling (score ranged from 0 to 42) where higher score means higher gross motor function in this position.
Measured: 12 weeks
Gross Motor Function Measure 88- Standing
assess the gross motor function in standing position using Gross Motor Function Measure 88-standing (score ranged from 0 to 39) where higher score means higher gross motor function in this position.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study start1 Oct 2017
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Manchester Metropolitan University
- Responsible party
- Principal investigator, Dr Tamis Wai-mun PIN, The Hong Kong Polytechnic University
- Investigators
- Tamis W Pin, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975804
- Sponsor's protocol ID
- 14150171
- Status last verified
- Aug 2019
- First submitted
- 24 Nov 2016
- Last updated
- 7 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oskoui M, Coutinho F, Dykeman J, Jette N, Pringsheim T. An update on the prevalence of cerebral palsy: a systematic review and meta-analysis. Dev Med Child Neurol. 2013 Jun;55(6):509-19. doi: 10.1111/dmcn.12080. Epub 2013 Jan 24.
PubMed 23346889Yam WK, Chan HS, Tsui KW, Yiu BP, Fong SS, Cheng CY, Chan CW; Working Group on Cerebral Palsy, Hong Kong Society of Child Neurology and Developmental Paediatrics. Prevalence study of cerebral palsy in Hong Kong children. Hong Kong Med J. 2006 Jun;12(3):180-4.
PubMed 16760544Mutch L, Alberman E, Hagberg B, Kodama K, Perat MV. Cerebral palsy epidemiology: where are we now and where are we going? Dev Med Child Neurol. 1992 Jun;34(6):547-51. doi: 10.1111/j.1469-8749.1992.tb11479.x. No abstract available.
PubMed 1612216Palisano R, Rosenbaum P, Walter S, Russell D, Wood E, Galuppi B. Development and reliability of a system to classify gross motor function in children with cerebral palsy. Dev Med Child Neurol. 1997 Apr;39(4):214-23. doi: 10.1111/j.1469-8749.1997.tb07414.x.
PubMed 9183258Butler PB, Saavedra S, Sofranac M, Jarvis SE, Woollacott MH. Refinement, reliability, and validity of the segmental assessment of trunk control. Pediatr Phys Ther. 2010 Fall;22(3):246-57. doi: 10.1097/PEP.0b013e3181e69490.
PubMed 20699770Rachwani J, Santamaria V, Saavedra SL, Wood S, Porter F, Woollacott MH. Segmental trunk control acquisition and reaching in typically developing infants. Exp Brain Res. 2013 Jul;228(1):131-9. doi: 10.1007/s00221-013-3544-y. Epub 2013 May 17.
PubMed 23681292Banas BB, Gorgon EJ. Clinimetric properties of sitting balance measures for children with cerebral palsy: a systematic review. Phys Occup Ther Pediatr. 2014 Aug;34(3):313-34. doi: 10.3109/01942638.2014.881952. Epub 2014 Feb 3.
PubMed 24490854Fehlings D, Switzer L, Findlay B, Knights S. Interactive computer play as "motor therapy" for individuals with cerebral palsy. Semin Pediatr Neurol. 2013 Jun;20(2):127-38. doi: 10.1016/j.spen.2013.06.003.
PubMed 23948687Sandlund M, McDonough S, Hager-Ross C. Interactive computer play in rehabilitation of children with sensorimotor disorders: a systematic review. Dev Med Child Neurol. 2009 Mar;51(3):173-9. doi: 10.1111/j.1469-8749.2008.03184.x. Epub 2009 Jan 26.
PubMed 19191834Snider L, Majnemer A, Darsaklis V. Virtual reality as a therapeutic modality for children with cerebral palsy. Dev Neurorehabil. 2010;13(2):120-8. doi: 10.3109/17518420903357753.
PubMed 20222773Deutsch JE, Borbely M, Filler J, Huhn K, Guarrera-Bowlby P. Use of a low-cost, commercially available gaming console (Wii) for rehabilitation of an adolescent with cerebral palsy. Phys Ther. 2008 Oct;88(10):1196-207. doi: 10.2522/ptj.20080062. Epub 2008 Aug 8.
PubMed 18689607Jelsma J, Pronk M, Ferguson G, Jelsma-Smit D. The effect of the Nintendo Wii Fit on balance control and gross motor function of children with spastic hemiplegic cerebral palsy. Dev Neurorehabil. 2013;16(1):27-37. doi: 10.3109/17518423.2012.711781. Epub 2012 Oct 3.
PubMed 23030836Ramstrand N, Lygnegard F. Can balance in children with cerebral palsy improve through use of an activity promoting computer game? Technol Health Care. 2012;20(6):501-10. doi: 10.3233/THC-2012-0696.
PubMed 23187015Sharan D, Ajeesh PS, Rameshkumar R, Mathankumar M, Paulina RJ, Manjula M. Virtual reality based therapy for post operative rehabilitation of children with cerebral palsy. Work. 2012;41 Suppl 1:3612-5. doi: 10.3233/WOR-2012-0667-3612.
PubMed 22317271Wade W, Porter D. Sitting playfully: does the use of a centre of gravity computer game controller influence the sitting ability of young people with cerebral palsy? Disabil Rehabil Assist Technol. 2012 Mar;7(2):122-9. doi: 10.3109/17483107.2011.589485. Epub 2011 Oct 4.
PubMed 21967300
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Interactive Computer Play on Trunk Control and Gross Motor Function in Children With Cerebral Palsy: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02975804
- Acronym / sponsor ID
- 14150171
- Conditions
- Cerebral Palsy, Exercise Therapy, Postural Balance
- Keywords
- cerebral palsy, video games, postural control, balance, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Manchester Metropolitan University
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 29 Nov 2016 (estimated)
- Results
- Posted 7 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive computer play (ICP) | Experimental | Device: TymoThe 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. |
| Standard Therapy | No intervention | –Children in the control group will continue their usual therapy. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children with a diagnosis of CP will be of GMFCS levels III to IV, who in general, require walking aid (level III) during ambulation and with limited walking ability (level IV).[4] Aiming to achieve a higher homogeneity of the recruited children, for those with level III, only those requiring physical assistance to climb stairs will be recruited and so it is believed that only those with lower motor ability, i.e. similar to level IV, will be included.
- Children, with non-CP physical disabilities, will have similar gross motor function as in (1).
- Aged from 6 to 12 years old and
- Able to follow instructions to interact in simple computer games
Key exclusion criteria (1 listed)
- Children with epilepsy/ seizures that could be elicited by flashing lights or sudden loud noises from computer screens
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TymoAll 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. | Device | Interactive computer play (ICP) |
Primary outcome
Segmental Assessment on Trunk Control-static
Time frame: 12 weeks
assess the level of static segmental trunk control. Assessment score represents as follows: 1= learning head control, 2= learning upper thoracic control, 3= learning mid-thoracic control, 4= learning lower thoracic control, 5= learning at upper lumber control, 6= learning lower lumbar control, 7= learning full trunk control and 8= achieved full trunk control.
Segmental Assessment on Trunk Control-active
Time frame: 12 weeks
assess the level of active segmental trunk control. Assessment score represents as follows: 1= learning head control, 2= learning upper thoracic control, 3= learning mid-thoracic control, 4= learning lower thoracic control, 5= learning at upper lumber control, 6= learning lower lumbar control, 7= learning full trunk control and 8= achieved full trunk control.
Segmental Assessment on Trunk Control-reactive
Time frame: 12 weeks
assess the level of reactive segmental trunk control. Assessment score represents as follows: 1= learning head control, 2= learning upper thoracic control, 3= learning mid-thoracic control, 4= learning lower thoracic control, 5= learning at upper lumber control, 6= learning lower lumbar control, 7= learning full trunk control and 8= achieved full trunk control.
14 secondary outcomes
Pediatric Reach Test-forward Sitting
Time frame: 12 weeks
Pediatric Reach Test- Right Sitting
Time frame: 12 weeks
Pediatric Reach Test- Left Sitting
Time frame: 12 weeks
Pediatric Reach Test- Forward Standing
Time frame: 12 weeks
Pediatric Reach Test- Right Standing
Time frame: 12 weeks
Pediatric Reach Test- Left Standing
Time frame: 12 weeks
Gross Motor Function Measure Item Set- Total Score
Time frame: 12 weeks
2-minute Walk Test
Time frame: 12 weeks
Height
Time frame: 12 weeks
Weight
Time frame: 12 weeks
Gross Motor Function Measure 88- Lying
Time frame: 12 weeks
Gross Motor Function Measure 88- Sitting
Time frame: 12 weeks
Gross Motor Function Measure 88- Crawling and Kneeling
Time frame: 12 weeks
Gross Motor Function Measure 88- Standing
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23346889Oskoui M, Coutinho F, Dykeman J, Jette N, Pringsheim T. An update on the prevalence of cerebral palsy: a systematic review and meta-analysis. Dev Med Child Neurol. 2013 Jun;55(6):509-19. doi: 10.1111/dmcn.12080. Epub 2013 Jan 24.
- Background: PubMed 16760544Yam WK, Chan HS, Tsui KW, Yiu BP, Fong SS, Cheng CY, Chan CW; Working Group on Cerebral Palsy, Hong Kong Society of Child Neurology and Developmental Paediatrics. Prevalence study of cerebral palsy in Hong Kong children. Hong Kong Med J. 2006 Jun;12(3):180-4.
- Background: PubMed 1612216Mutch L, Alberman E, Hagberg B, Kodama K, Perat MV. Cerebral palsy epidemiology: where are we now and where are we going? Dev Med Child Neurol. 1992 Jun;34(6):547-51. doi: 10.1111/j.1469-8749.1992.tb11479.x. No abstract available.
- Background: PubMed 9183258Palisano R, Rosenbaum P, Walter S, Russell D, Wood E, Galuppi B. Development and reliability of a system to classify gross motor function in children with cerebral palsy. Dev Med Child Neurol. 1997 Apr;39(4):214-23. doi: 10.1111/j.1469-8749.1997.tb07414.x.
- Background: PubMed 20699770Butler PB, Saavedra S, Sofranac M, Jarvis SE, Woollacott MH. Refinement, reliability, and validity of the segmental assessment of trunk control. Pediatr Phys Ther. 2010 Fall;22(3):246-57. doi: 10.1097/PEP.0b013e3181e69490.
- Background: PubMed 23681292Rachwani J, Santamaria V, Saavedra SL, Wood S, Porter F, Woollacott MH. Segmental trunk control acquisition and reaching in typically developing infants. Exp Brain Res. 2013 Jul;228(1):131-9. doi: 10.1007/s00221-013-3544-y. Epub 2013 May 17.
- Background: PubMed 24490854Banas BB, Gorgon EJ. Clinimetric properties of sitting balance measures for children with cerebral palsy: a systematic review. Phys Occup Ther Pediatr. 2014 Aug;34(3):313-34. doi: 10.3109/01942638.2014.881952. Epub 2014 Feb 3.
- Background: PubMed 23948687Fehlings D, Switzer L, Findlay B, Knights S. Interactive computer play as "motor therapy" for individuals with cerebral palsy. Semin Pediatr Neurol. 2013 Jun;20(2):127-38. doi: 10.1016/j.spen.2013.06.003.
- Background: PubMed 19191834Sandlund M, McDonough S, Hager-Ross C. Interactive computer play in rehabilitation of children with sensorimotor disorders: a systematic review. Dev Med Child Neurol. 2009 Mar;51(3):173-9. doi: 10.1111/j.1469-8749.2008.03184.x. Epub 2009 Jan 26.
- Background: PubMed 20222773Snider L, Majnemer A, Darsaklis V. Virtual reality as a therapeutic modality for children with cerebral palsy. Dev Neurorehabil. 2010;13(2):120-8. doi: 10.3109/17518420903357753.
- Background: PubMed 18689607Deutsch JE, Borbely M, Filler J, Huhn K, Guarrera-Bowlby P. Use of a low-cost, commercially available gaming console (Wii) for rehabilitation of an adolescent with cerebral palsy. Phys Ther. 2008 Oct;88(10):1196-207. doi: 10.2522/ptj.20080062. Epub 2008 Aug 8.
- Background: PubMed 23030836Jelsma J, Pronk M, Ferguson G, Jelsma-Smit D. The effect of the Nintendo Wii Fit on balance control and gross motor function of children with spastic hemiplegic cerebral palsy. Dev Neurorehabil. 2013;16(1):27-37. doi: 10.3109/17518423.2012.711781. Epub 2012 Oct 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamis W Pin, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tymo in people with Cerebral Palsy and Exercise Therapy, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Segmental Assessment on Trunk Control-static (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02975804, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.