Innovative Game-Aided Rehabilitation Platform for Rehabilitation of Balance in Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Peabody Developmental Motor Scale-2 (PDMS-2)
研究概览
简要总结
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).
详细描述
The research project focuses on the evaluation of an innovative, 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.
Canada and India face a growing population of children with neurodevelopmental disabilities distributed across broad geographic regions. Cerebral palsy (CP) is the most common neurodevelopmental disability in childhood. The prevalence of CP in developing countries is estimated to be 5 to 10 times greater than in North America. Children with CP face a substantial amount of balance impairments which results in limitations of the mobility functions necessary for activities of daily living. The ability to perform functional tasks in sitting and standing while maintaining the balance is an important predictor of success in daily activities and participation in school, leisure and other aspects of community life.
There are many things to consider when developing therapy programs designed to improve dynamic balance skills for these affected children to maximize the neurodevelopmental capacities and to prevent the development of secondary disabilities. Intense repetitive task practice (RTP) such as, constraint-induced movement therapy is one of the few effective neuro-rehabilitative strategies shown to improve motor function in children with CP, with potential to overcome developmental difficulties. Constraint induced movement therapy consists of constraining the use of the unaffected limb to encourage use of the affected limb. However it is often difficult to engage children in therapy and sustain motivation to engage in intense RTP and achieve the therapy goals. Thus, there is a need for effective approaches and tools that motivate young children with CP to complete long-term neuro-rehabilitation programs and to provide developmental opportunities.
Digital media and gaming have received considerable interest from researchers and clinicians as a model for learning a broad range of complex tasks and facilitating the transfer of skills to daily life. These emerging rehabilitation technologies have the potential to improve clinical outcomes and child participation because these are engaging, motivating and now accessible. For this purpose a computer game-aided rehabilitation platform (CRP) has been developed. This approach combines motor exercises with fun games appropriate for children with neuro- developmental disorders. The approach is designed to provide engaging, high-quality, personalized therapy in the clinical rehabilitation setting.
Research Goal:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with confirmed medical diagnosis of Cerebral Palsy
- •Age group - 3-8 years
- •GMFCS level - 1-3
- •Modified Ashworth scale level 0 to +
- •Exclusion criteria:
- •Visual or auditory impairment such that the interaction with the video games is difficult;
- •Secondary orthopedic complications due to neurodegenerative disease (NDD)
- •Modified Ashworth scale level > +1,
- •GMFCS level - 4-5,
- •Recent Botulinum toxin therapy (less than 6 months);
- •Recent Surgical intervention,
- •Cognitive impairment
- •Non willing parents,
- •Seizures, or
- •Complex communication disorders.
- •Tools for Screening:
- •Gross Motor Function Classification System (GMFCS) &
- •Modified Ashworth Scale.
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Computer Games-Aided Balance Training Protocol (Other)
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.
干预措施: Conventional Balance Training Protocol (Other)
结局指标
主要结局
Peabody Developmental Motor Scale-2 (PDMS-2)
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点