Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT02728375 |
| Other study ID # |
H2016:061 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
March 22, 2016 |
| Last updated |
April 4, 2016 |
| Start date |
April 2016 |
| Est. completion date |
December 2016 |
Study information
| Verified date |
March 2016 |
| Source |
University of Manitoba |
| Contact |
Tony Szturm, Ph.D. |
| Email |
tony.szturm[@]umanitoba.ca |
| Is FDA regulated |
No |
| Health authority |
Canada: Health Research Ethics Board, University of Manitoba |
| Study type |
Interventional
|
Clinical Trial Summary
This research project focuses on the evaluation of an engaging exercise and cognitive
computer game-based platform and embedded assessment tools for use in clinical practice and
its transition to use in the home, and elementary classrooms. The goal of our research
program is to produce innovative therapeutic point-of-care and cost-effective delivery
system leading to better long-term health outcomes for toddlers and children with
neurodevelopmental disabilities. The program is grounded on our 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. We will conduct a randomized controlled trial to study the feasibility and
effectiveness of a computer-aided, game-based repetitive task practice (RTP) program
designed for training of fine and gross motor skills of the hand-arms and psychomotor skills
(which) in young children with CP.
Description:
This research project focuses on the evaluation of an innovative, engaging computer
game-based exercise system for use in rehabilitation of young children with cerebral palsy,
and its transition for use in home. 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
their neuro-developmental capacities, sustain any behavioral recovery and prevent future
complications.
Canada and India face a growing population of children with neuro-developmental disabilities
distributed across broad geographic regions. Cerebral palsy is the most common
neuro-developmental disability in childhood. The prevalence of cerebral palsy (CP) in
developing countries is estimated to be 5 to 10 times greater than in North America.
Children with CP can result in deficits in fine and gross motor skills and often have
co-occurring deficits in attention and cognitive functions. Half of these children with CP
have impaired upper extremity function (reaching, grasping and manipulating objects). The
ability to perform functional tasks with the upper extremities 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 motor
and psychomotor skills for affected children to maximize their neuro-developmental
capacities and to prevent the development of secondary disabilities. Intense repetitive task
practice such as, constraint-induced movement therapy is one of the few effective
neuro-rehabilitative strategies shown to improve upper extremity motor function in children
with CP, with potential to overcome developmental difficulties. Constraint induced movement
therapy consists of constraining the use of the unaffected upper limb to encourage use of
the affected upper limb. However it is often difficult to engage children in therapy and
sustain motivation to engage in intense repetitive task practice in using the affected upper
limb. 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 they are engaging, motivating and
now accessible. For this purpose investigators have developed a computer game-based
rehabilitation and learning platform (CRP). This approach combines fine and gross motor
exercises and cognitive activities appropriate for children with neuro- developmental
disorders. The approach is designed to provide engaging, high-quality, personalized therapy
in the clinical rehabilitation setting, and which could also be implemented in the school
and home via Tele rehabilitation.
Research Goal:
This research project focuses on the evaluation of an engaging exercise and cognitive
computer game-based platform and embedded assessment tools for use in clinical practice and
its transition to use in the home, and elementary classrooms. The goal of this research
program is to produce innovative therapeutic point-of-care and cost-effective delivery
system leading to better long-term health outcomes for toddlers and children with
neurodevelopmental disabilities. The program is grounded on investigators 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. Investigators will conduct a randomized controlled trial to study the
feasibility and effectiveness of a computer-aided, game-based repetitive task practice (RTP)
program designed for training of fine and gross motor skills of the hand-arms and
psychomotor skills (which) in young children with CP.
RESEARCH PROJECT OBJECTIVE 1
The CRP 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 and therapist.
Objective: To evaluate the test-retest reliability and convergent validity of the assessment
tool embedded in the game-based rehabilitation platform. Specifically for fine and gross
motor skills and psychomotor skills in children aged 4-11 years (n= 40) diagnosed with
cerebral palsy or acquired brain injuries. The new tool will be compared to commonly used
outcome measures i.e. Quality of Upper Extremity skills test (QUEST) and Peabody
Developmental Motor Scale version 2 (PDMS-2). This will provide a reliable test protocol and
valid measures that can accurately and quickly quantify hand-arm function independent of
object-task type, for use in daily clinical practice and research. Two common tests of fine
and gross motor skill in CP children; a) Quality of Upper Extremity Skills Test (QUEST) and
b) Peabody Developmental Motor Scale-2. We 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 exploratory randomized clinical trial will be conducted to evaluate the feasibility and
benefits of the game-based rehabilitation program on fine manual dexterity skills and gross
motor skills in children aged 4-11 years (n= 60) diagnosed with cerebral palsy. Two groups
of children will be examined, one group will receive the experimental game-based program and
the other group will receive usual therapy. Each program would take 16 weeks, three therapy
sessions per week. Using a process of randomization, participants will be assigned to either
experimental or control group after the initial assessment and screening performed by a
blind assessor. Before the treatment sessions begin, after the end of 16 weeks and during a
follow up session after 16 weeks, a clinician will conduct regular assessment sessions with
the participant to mark the progress till date.
Investigators will be examining the feasibility of assessment tool embedded in the
game-based rehabilitation platform and also the usability safety and appeal of the protocol.
Investigators will observe a estimation of effectiveness on this sample using mixed method
Analysis of Variance for within (repeated measure) and between group effects.
STUDY DESIGN: Exploratory Randomized Clinical Trial
METHOD OF COLLECTION OF DATA:
Ethical clearance for the study has been obtained from the Institutional Ethical Committee
of S. D. M. College of Medical Sciences and Hospital, Dharwad and will be obtained from
Institutional Ethical committee of Christian Medical College, Ludhiana, India. Participants
will be recruited by clinicians working in Outpatient Department, S.D.M. Hospital, Dharwad,
India and Christian Medical College and Hospital, Ludhiana, India. Participants who consent
to take part in the study will be asked to use objects instrumented with the miniature
motion mouse to play various therapeutic yet entertaining games while handling and moving
the test therapeutic objects as a part of experimental therapy protocol. The objects used
will be everyday items; a) lifting/rotating a sports ball small beach ball which requires
bimanual handling, b) rolling a cylinder object (diameter 6-10 cm with fingers extended and
using elbow and shoulder motion, c) grasping grasp small glass and then a sponge ball with
whole hand and rotating (supination- pronation motion) d) motion of a small wand (pencil)
with 3-finger pinch grip and using hand-wrist motion, and e) turning of a key with 2-finger
pinch fine finger control. These objects represent a wide range of physical properties
requiring different modes of manipulation and functional demands sufficient to test the
assessment tool. In control group: 1) Stretching of Biceps, Lattisimus dorsi, Pronators,
Thumb muscles. 2) Weight Bearing Exercises. 3) CIMT for 20 min per day for 3-4 weeks, repeat
each task 15-20 times. Pegboard activities, Rings: reaching- removing and putting back, Ball
throw (under and over arm) - at basket which is kept 10 to 15 meter distance, opening bottle
cap (large size bottle), Opening and closing door handle activity, Holding water bottle, bag
in hand and transfer to 10 to 20 meter distance, Crumbling paper, Clay activities, Picking
marbles from sand 4)Hand arm bimanual activities: Throwing ball with both hands, Holding
ball with both hands and transfer, Holding bolster and keeping at place, Holding notebook in
both hands, Holding rack with both hands, Holding plate in one hand and spoon in other hand,
Pushing door or wall both hands.
Further if parents have any queries regarding the study they can report to the principal
investigators. The parents would be reassured that information would be kept confidential
and will be used only for study purpose.
