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Innovative Game-Aided Rehabilitation Platform for Rehabilitation of Balance in Children With Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT03873441
Recruitment Status : Not yet recruiting
First Posted : March 13, 2019
Last Update Posted : March 15, 2019
Sponsor:
Collaborator:
SDM College of Medical Sciences & Hospital
Information provided by (Responsible Party):
University of Manitoba

Brief Summary:
The research project focuses on the evaluation of an engaging computer game-aided rehabilitation platform for use in rehabilitation of young children with cerebral palsy. The goal of this research program is to produce high quality therapeutic point-of-care approaches and cost-effective delivery systems leading to better long-term health outcomes. At present, the challenges entailed in providing therapy services continue to put identified children at risk of missing opportunities to maximize the neurodevelopmental capacities, sustain any behavioral recovery and prevent future complications.The program is grounded on the technological developments and on current research documenting the benefits of computer-aided learning tools, exercise gaming applications in rehabilitation and principles of adaptive learning and neuroplasticity. A randomized controlled trial (RCT) will be conducted to study the feasibility and effectiveness of a computer game-aided rehabilitation platform (CGR) for a repetitive task practice (RTP) protocol designed for training of balance in young children with Cerebral Palsy (CP).

Condition or disease Intervention/treatment Phase
Cerebral Palsy Other: Computer Games-Aided Balance Training Protocol Other: Conventional Balance Training Protocol Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Innovative Game-Aided Rehabilitation Platform for Rehabilitation of Balance in Children With Cerebral Palsy
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Computer Games-Aided Balance Training Group
The participants in CGR group will be asked to sit or stand (as per the screening result) on fixed & compliant surfaces; to use objects instrumented with the miniature motion mouse to play various therapeutic yet entertaining games while handling and moving the test therapeutic objects using bi-manual grip gradually progressing to head rotations (mouse mounted on a cap worn by participant); finally using trunk movements as a part of experimental therapy protocol. While performing CGR; children will be standing on a thin pressure mat (placed over fixed or compliant surface). This will allow us to record the information of COP displacement [body sway] while CGR intervention implementation. This information will be used to quantify therapy dosage. The CGR Group will receive a 45-60 minutes of session thrice a week for 12 weeks.
Other: Computer Games-Aided Balance Training Protocol

1) Sitting Balance exercises while playing the interactive computer games starting with bi manual object placed in hands for controlling the games, then using the head rotation movements to control the games progressing to use of trunk motions to control games while balancing on the compliant surfaces in order to progress by increasing the balance costs.

(2) Standing Balance exercises progressing from a fixed support surface to uneven, compliant surfaces like progression from standing over ground to sponge to air bladder as child tolerates increased balance costs.

(3) Progression then to balancing while performing the visuomotor and visuospatial game tasks such as playing the games starting with bi-manual object placed in hands for controlling the games, then using the head rotation movements to control the games and then progressing to use of trunk motions to control games while balancing on compliant surface.

(4) Progression to single-leg stance and stepping activities.

Other Name: CGR Balance Training Protocol

Active Comparator: Conventional Balance Training Group
The control group will be receiving the conventional balance training for static and dynamic balance function improvement. The therapy will be provided in sitting or standing (as per the screening result) in a graded manner progressing from fixed surfaces to movable compliant surfaces. The Conventional Balance Training Group will receive a 45-60 minutes of session thrice a week for 12 weeks.
Other: Conventional Balance Training Protocol

The following is a summary of the conventional physical therapy balance training protocol:

  1. Active-assisted stretching exercises for lower limb musculature focusing on postural control and improvement in dynamic stability,
  2. Balance and weight bearing exercises with multi-directional reach outs associated with trunk movements on fixed surface gradually progressing to unstable movable and compliant surfaces,
  3. Weight transfer exercises with multi-directional reach outs and
  4. Stepping exercises in different directions on variety of surfaces.




Primary Outcome Measures :
  1. Peabody Developmental Motor Scale-2 (PDMS-2) [ Time Frame: Changes from baseline to post-intervention i.e. at 12 weeks ]
    The PDMS-2 is an early childhood motor development program that provides both in-depth assessment and training or remediation of gross and fine motor skills. The assessment is composed of six sub-tests that measure interrelated motor abilities that develop early in life. It is designed to assess the motor skills of children from birth through 5 years of age. The Stationary, Locomotion and Object Manipulation sub-tests of this scale will be used as the primary outcome measures of the study.

  2. Gross Motor Function Measure [ Time Frame: Changes from baseline to post-intervention i.e. at 12 weeks ]
    The GMFM is an observational clinical tool designed to evaluate change in gross motor function in children with CP aged between 5 months to 16 years. The sitting, crawling and kneeling, standing, walking and running components of the scale will be used as the primary outcome measures of the study.

  3. COP Displacement Measures [ Time Frame: Changes from baseline to post-intervention i.e. at 12 weeks ]
    The assessment of the center of foot pressure (COP) displacement using BodiTrack Pressure Mapping System while performance of the modified CTSIB tasks on normal and compliant surfaces will be taken at baseline and after implementation of intervention to assess the response of the balance control in variety of conditions.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Children with confirmed medical diagnosis of Cerebral Palsy
  2. Age group - 3-8 years
  3. GMFCS level - 1-3
  4. Modified Ashworth scale level 0 to +1.

Exclusion criteria:

  1. Visual or auditory impairment such that the interaction with the video games is difficult;
  2. Secondary orthopedic complications due to neurodegenerative disease (NDD)
  3. Modified Ashworth scale level > +1,
  4. GMFCS level - 4-5,
  5. Recent Botulinum toxin therapy (less than 6 months);
  6. Recent Surgical intervention,
  7. Cognitive impairment
  8. Non willing parents,
  9. Seizures, or
  10. Complex communication disorders.

Tools for Screening:

  1. Gross Motor Function Classification System (GMFCS) &
  2. Modified Ashworth Scale.

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): NCT03873441


Locations
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Canada, Manitoba
School of Medical Rehabilitation , University of Mantioba
Winnipeg, Manitoba, Canada, R3e 0T6
University of Manitoba Not yet recruiting
Winnipeg, Manitoba, Canada, R3E 0T6
Contact: Tony Szturm, Ph.D.    2047874794    tony.szturm@umanitoba.ca   
Contact: Kavisha M Mehta, M. Sc.    +14319973334    mehtak@myumanitoba.ca   
Sponsors and Collaborators
University of Manitoba
SDM College of Medical Sciences & Hospital

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Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT03873441     History of Changes
Other Study ID Numbers: HS22614 (H2019:081)
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 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 University of Manitoba:
Cerebral Palsy
Balance
Rehabilitation
Additional relevant MeSH terms:
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Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases