RCT on Interactive Computer Play on Trunk Control in CP

NCT02975804 | Completed Results DMC

• 1 other identifier: 14150171
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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 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

Keywords

cerebral palsy; video games; postural control; balance; children

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  12 weeks

Secondary Outcomes (14)

• Pediatric Reach Test-forward Sitting

  12 weeks

• Pediatric Reach Test- Right Sitting

  12 weeks

• Pediatric Reach Test- Left Sitting

  12 weeks

• Pediatric Reach Test- Forward Standing

  12 weeks

• Pediatric Reach Test- Right Standing

  12 weeks

Study Arms (2)

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.

Device: Tymo

Standard Therapy

NO INTERVENTION

Children in the control group will continue their usual therapy.

Interventions

Tymo DEVICE

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.

Interactive computer play (ICP)

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Children with epilepsy/ seizures that could be elicited by flashing lights or sudden loud noises from computer screens

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Manchester Metropolitan University: collaborator

Study Sites (1)

The Hong Kong Polytechnic University

Hung Hom, Hong Kong

Location

Related Publications (17)

• 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.

  PMID: 23346889 BACKGROUND

• Yam 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.

  PMID: 16760544 BACKGROUND

• Mutch 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.

  PMID: 1612216 BACKGROUND

• Palisano 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.

  PMID: 9183258 BACKGROUND

• Butler 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.

  PMID: 20699770 BACKGROUND

• Rachwani 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.

  PMID: 23681292 BACKGROUND

• Banas 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.

  PMID: 24490854 BACKGROUND

• Fehlings 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.

  PMID: 23948687 BACKGROUND

• Sandlund 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.

  PMID: 19191834 BACKGROUND

• Snider 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.

  PMID: 20222773 BACKGROUND

• Deutsch 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.

  PMID: 18689607 BACKGROUND

• Jelsma 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.

  PMID: 23030836 BACKGROUND

• Ramstrand 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.

  PMID: 23187015 BACKGROUND

• Sharan 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.

  PMID: 22317271 BACKGROUND

• Wade 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.

  PMID: 21967300 BACKGROUND

• Bartlett D, Birmingham T. Validity and reliability of a pediatric reach test. Pediatr Phys Ther. 2003 Summer;15(2):84-92. doi: 10.1097/01.PEP.0000067885.63909.5C.

  PMID: 17057438 BACKGROUND

• Pin TW. Psychometric properties of 2-minute walk test: a systematic review. Arch Phys Med Rehabil. 2014 Sep;95(9):1759-75. doi: 10.1016/j.apmr.2014.03.034. Epub 2014 May 9.

  PMID: 24814460 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Limitations and Caveats

1. Children should have a reasonable level of cognitive function to participate in the interactive computer play. Cognitive impairment is a common co-morbidities. 2. Small sample size 3. Increase type 1 error as repeated measurements on participants

Results Point of Contact

• Title: Dr tamis W Pin
• Organization: The Hong Kong Polytechnic University

tamis.pin@polyu.edu.hk

85227666751

Study Officials

• Tamis W Pin, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 24, 2016
• First Posted: November 29, 2016
• Study Start: October 1, 2017
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: August 7, 2019
• Results First Posted: August 7, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)