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
|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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
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:
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873441
|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 firstname.lastname@example.org|
|Contact: Kavisha M Mehta, M. Sc. +14319973334 email@example.com|