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RCT on Interactive Computer Play on Trunk Control in CP

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ClinicalTrials.gov Identifier: NCT02975804
Recruitment Status : Completed
First Posted : November 29, 2016
Results First Posted : August 7, 2019
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
Manchester Metropolitan University
Information provided by (Responsible Party):
Dr Tamis Wai-mun PIN, The Hong Kong Polytechnic University

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.


Condition or disease Intervention/treatment Phase
Cerebral Palsy Exercise Therapy Postural Balance Device: Tymo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Interactive Computer Play on Trunk Control and Gross Motor Function in Children With Cerebral Palsy: a Pilot Randomized Controlled Trial
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Interactive computer play (ICP)
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
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.

No Intervention: Standard Therapy
Children in the control group will continue their usual therapy.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Pediatric Reach Test-forward Sitting [ Time Frame: 12 weeks ]
    assess how far the child can reach forward in sitting

  2. Pediatric Reach Test- Right Sitting [ Time Frame: 12 weeks ]
    assess how far the child can reach to his/her right in sitting

  3. Pediatric Reach Test- Left Sitting [ Time Frame: 12 weeks ]
    assess how far the child can reach to his/her left in sitting

  4. Pediatric Reach Test- Forward Standing [ Time Frame: 12 weeks ]
    assess how far the child can reach forward in standing

  5. Pediatric Reach Test- Right Standing [ Time Frame: 12 weeks ]
    assess how far the child can reach to his/her right in standing

  6. Pediatric Reach Test- Left Standing [ Time Frame: 12 weeks ]
    assess how far the child can reach to his/her left in standing

  7. Gross Motor Function Measure Item Set- Total Score [ Time Frame: 12 weeks ]
    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.

  8. 2-minute Walk Test [ Time Frame: 12 weeks ]
    measure how far the study participant can walk in 2 minutes in metres

  9. Height [ Time Frame: 12 weeks ]
    measure the height of study participants in centimetres

  10. Weight [ Time Frame: 12 weeks ]
    measure the body weight of study participants in kilograms

  11. Gross Motor Function Measure 88- Lying [ Time Frame: 12 weeks ]
    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.

  12. Gross Motor Function Measure 88- Sitting [ Time Frame: 12 weeks ]
    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.

  13. Gross Motor Function Measure 88- Crawling and Kneeling [ Time Frame: 12 weeks ]
    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.

  14. Gross Motor Function Measure 88- Standing [ Time Frame: 12 weeks ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Children, with non-CP physical disabilities, will have similar gross motor function as in (1).
  3. Aged from 6 to 12 years old and
  4. Able to follow instructions to interact in simple computer games

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02975804


Locations
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Hong Kong
The Hong Kong Polytechnic University
Hung Hom, Hong Kong
Sponsors and Collaborators
The Hong Kong Polytechnic University
Manchester Metropolitan University
Investigators
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Principal Investigator: Tamis W Pin, PhD Hong Kong Polytechnic University
  Study Documents (Full-Text)

Documents provided by Dr Tamis Wai-mun PIN, The Hong Kong Polytechnic University:
Publications:

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Responsible Party: Dr Tamis Wai-mun PIN, Assistant Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT02975804    
Other Study ID Numbers: 14150171
First Posted: November 29, 2016    Key Record Dates
Results First Posted: August 7, 2019
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Tamis Wai-mun PIN, The Hong Kong Polytechnic University:
cerebral palsy
video games
postural control
balance
children
Additional relevant MeSH terms:
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Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases