Cerebral Palsy Clinical Trial
Official title:
Innovative Game-Aided Rehabilitation Platform for Rehabilitation of Balance in Children With Cerebral Palsy
Verified date | March 2019 |
Source | University of Manitoba |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | July 2020 |
Est. primary completion date | July 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 8 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Canada | School of Medical Rehabilitation , University of Mantioba | Winnipeg | Manitoba |
Canada | University of Manitoba | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
University of Manitoba | SDM College of Medical Sciences & Hospital |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Peabody Developmental Motor Scale-2 (PDMS-2) | 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. | Changes from baseline to post-intervention i.e. at 12 weeks | |
Primary | Gross Motor Function Measure | 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. | Changes from baseline to post-intervention i.e. at 12 weeks | |
Primary | COP Displacement Measures | 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. | Changes from baseline to post-intervention i.e. at 12 weeks |
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