Cerebral Palsy Clinical Trial
Official title:
Innovative Game-Aided Rehabilitation Platform for Rehabilitation of Balance in Children With Cerebral Palsy
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).
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:
This research project focuses on the evaluation of an engaging exercise computer game-aided
platform and embedded assessment tools for use in clinical practice. 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 pilot study to examine the feasibility and
benefits of a computer-aided, game-aided repetitive task practice (RTP) program designed for
training of dynamic balance skills in young children with CP will be conducted.
RESEARCH PROJECT OBJECTIVE 1
The CGR includes a designed rehabilitation assessment game which is capable of monitoring
every child's performance during therapy. It quantifies motor skill parameters, as well as,
visual-spatial skills and executive cognitive functions. It produces electronic records for
these outcome measures and thus allows us to track change over time. It also provides timely
feedback to child, parents and the therapist.
Objective: To evaluate the test-retest reliability and convergent validity of the assessment
tool embedded in the game-aided rehabilitation platform. Specifically for dynamic balance in
children aged 3-8 years (n= 50) diagnosed with CP. The new tool will be compared to commonly
used outcome measures i.e. Peabody Developmental Motor Scale version 2 (PDMS-2) and Gross
Motor Function Measure (GMFM). This will provide a reliable test protocol and valid measures
that can accurately and quickly quantify dynamic balance control function independent of
object-task type, for use in daily clinical practice and research. It is hypothesized that
the performance measures of the game-based assessment tool would:
1. Exhibit high test retest reliability (Intra class correlations >0.7), and Standard error
of measures less than 20% of the group mean.
2. Show moderate convergent validity (correlations, r>0.06) with the primary outcome
measures.
RESEARCH PROJECT OBJECTIVE 2
An feasibility randomized clinical trial will be conducted to examine recruitment,
acceptability, compliance and therapy dosage of the CRP program and to estimate the treatment
effect of the repetitive task practice game-aided exercise program on dynamic balance skills,
transfers from sitting to standing, turning, stepping, and gait function in children aged 3-8
years (n= 50) diagnosed with CP. Preliminary estimation of treatment effects and the
calculation of effect size and sample size for a full scale definitive RCT will be determined
on the basis of pre and post scores of the primary outcome measures. Two groups of children
will be examined, one group will receive the experimental game-aided balance training program
and the other group will receive usual conventional balance training program. Each program
would take 12 weeks, three therapy sessions per week. Using a process of randomization, every
child will be assigned to either experimental or control group after the initial assessment
and screening. Before the treatment sessions begin, after the end of 12 weeks, a clinician
will conduct regular assessment sessions with the participant to mark the progress till date.
The feasibility of assessment tool embedded in the game-aided rehabilitation platform and
also the usability, safety and appeal of the protocol will be examined. An estimation of
effectiveness on this sample using mixed method Analysis of Variance for within (repeated
measure) and between group effects will be observed.
RESEARCH PROJECT OBJECTIVE 3
It is important to develop evidence on quality and actual dosage of an intervention to be
delivered to create a positive outcome on the transfer of skills to functional performance.
Thus during each session the dosage of intervention will be determined by recording the
duration, intensity and quality of the balance and mobility exercises delivered with this
treatment model at each session. In turn the aim is to develop a dose-response relationship
for clinical use of this CRP program in rehabilitation of children with CP.
STUDY DESIGN: Feasibility Randomized Clinical Trial
METHOD OF COLLECTION OF DATA:
Ethical clearance for the study will be obtained from the Institutional Ethical Committee of
S. D. M. College of Medical Sciences and Hospital, Dharwad. Participants will be recruited by
clinicians working in Outpatient Department of Physiotherapy, S.D.M. Hospital, Dharwad,
Karnataka, India. Parents of the participants will be approached for consent to take part in
the study, the study participants in experimental group will be asked to sit or stand (as per
the screening result) on fixed and compliant surfaces and 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 (with the mouse mounted on a cap worn by the participant) and finally using trunk
movements as a part of experimental therapy protocol. The head movements and trunk movements
will increase the body sway and hence increase the balance cost of the exercises to result in
improvement in balance control. The speed and the amount of head or trunk movements (i.e.
balanced costs) will be graded by adjusting the difficulty level of game play. While
performing CGR the children will be standing on a thin pressure mat (placed over fixed or
compliant surface). This will allow us to record the information of Center of Foot Pressure
(COP) displacement [body sway] while game-aided balance training intervention implementation.
This information will be used to quantify the intensity and duration of each exercise (i.e.
therapy dose) for objective 3.
The following is a summary of the experimental balance training protocol:
1. Sitting Balance exercises while the child maintains sitting balance 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 and
then progressing to use of trunk motions to control games while balancing on the
compliant surface (air bladder); in order to progress by increasing the balance costs.
2. Standing Balance exercises progressing from a fixed support surface to uneven and
compliant support surfaces like progression from standing over ground then on sponge and
then on air bladder as the child tolerates, i.e. increased balance costs.
3. Progression then to balancing while performing the visuomotor and visuospatial game
tasks such as playing the games starting with bimanual 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 the
compliant surface.
4. Progression to single-leg stance and to stepping activities. The control group
participants will be receiving the conventional physical therapy protocol for balance
rehabilitation.
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.
Further if parents have any queries regarding the study can be reported to the principal
investigators. The parents would be reassured that information would be kept confidential and
will be used only for study purpose.
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