- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05494905
Virtual Reality vs Functional Strength Training in Children With Cerebral Palsy
Effect of Virtual Reality and Functional Strength Training on Arm Function in Children With Cerebral Palsy_2021
Virtual reality (VR) has shown to be effective to improve arm function in children with cerebral palsy (CP). Recently, functional strength training (FST) starts to show to improve arm function in patients with stroke but has not been extensively explored in children with CP. This pilot study is to examine the effect of FST and VR on improving arm function in children with CP using a sequential multiple assignment randomized trial (SMART) to develop valid, high-quality adaptive intervention using VR and FST to improve arm function in children with CP. There is a growing interest and need for research on how to adapt and re-adapt intervention in children with CP in order to maximize clinical benefits. The treatment adapted here is by augmenting or switching to the other intervention.
Forty children with spastic type of CP will be recruited from the greater Atlanta area. Children will be randomly assigned to receive either VR or FST for 6 weeks (60 minutes per day, 3 days per week). After receiving 6 weeks of intervention, the children will be evaluated to determine whether they are responders or non-responders. For those who are responders, they will continue receiving the same dosage and type of intervention. That is, children who are assigned to VR will continue receiving VR for the next 6 weeks; children who are assigned to FST will continue receiving FST for the next 6 weeks. For those who are non-responders, children will be randomly assigned to augmenting the other intervention or switching to the other intervention. That is, for children who are assigned to augmenting the other intervention (i.e. the combination group), they will receive the combination of FST and VR for the next 6 weeks. For children who are assigned to switch to the other intervention, children who are assigned to VR in the first 6 weeks will receive FST for the next 6 weeks; whereas children who are assigned to FST in the first 6 weeks will receive VR for the next 6 weeks. Similar instruction, visit, and email reminder will be conducted as what they receive in the first 6 weeks. At the end of the study, children and primary caregivers will be interviewed to understand their perception about the intervention they have received.
The research team is expected children with CP will improve their arm function regardless which intervention they are assigned; however, children received VR will have a better improvement in arm function as compared with those who received FST at the end of the intervention.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yuping Chen, ScD, PT
- Phone Number: 1-404-413-1256
- Email: ypchen@gsu.edu
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30303
- Recruiting
- Department of Physical Therapy, Georgia State University
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Contact:
- Yuping Chen, ScD, PT
- Phone Number: 404-413-1256
- Email: ypchen@gsu.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- children are between ages 5-17 years
- diagnosed with CP;
- have a Manual ability classification system (MACs) level I-III;
- able to sit with trunk supported;
- are able to reach forward for more than half of their arm length;
- are able to comprehend a 3-step command;
- are able to see video screen (with or without corrected vision); and
- their primary caregiver is willing to follow the desired intervention 'dosing' and all evaluation measurements.
Exclusion Criteria:
- children have received surgery or botulinum toxin type A injection in the training arm within the preceding 4 months or are scheduled to receive it during the planned study period,
- if children have a severe attention deficit or uncontrolled epilepsy which may possibly be triggered by the light or sound of the video games.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Virtual Reality (VR)
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In this project, the investigators focus on using our developed VR gaming platform called Super Pop VR, a VR system that can be individualized to the movement capabilities of the child.
It consists of the Microsoft Kinect camera, a laptop, software, and TV screen.
The research team will loan the system to the family.
While engaged with the game, the child is immersed in a virtual world where virtual objects appear on the screen surrounding the child.
Children are asked to move their arms to 'pop' as many virtual objects as possible in a certain amount of time.
Playstation 2 EyeToy and EyeToy 2 games will also be used to increase children's motivation by playing a variety of different VR games.
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Active Comparator: Functional Strength Training (FST)
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FST involves repetitive progressive resistance exercise during goal-directed functional activity with the children focus on the activity being performed.
Children will be offered a pamphlet containing suggested functional arm exercises and these exercises are designed to move the more affected arm in overhead, outward, and across midline directions.
Each exercise will be embedded in a game-like activity.
Children will start with no resistance and gradually add on resistance using elastic bands or weight cuffs.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reaching kinematics at the baseline
Time Frame: At baseline
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Reaching kinematics will be assessed while the child is interacting with Super Pop VRTM, wherein virtual bubbles are projected onto the TV in randomly dispersed locations, using the Kinect system.
Three testing bubbles will be tested in the location where children need to reach about arm length overhead at 180, 135, and 90 degrees of shoulder abduction, with instructions for children to reach in two conditions: 1) as fast as possible, and 2) as accurate as possible.
Position data from the Kinect will be converted into 3-dimensional coordinate data and kinematic variables (movement time, trajectory straightness, speed, smoothness) will be computed.
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At baseline
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Reaching kinematics at the end of the 6th week
Time Frame: The end of the 6th week
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Reaching kinematics will be assessed while the child is interacting with Super Pop VRTM, wherein virtual bubbles are projected onto the TV in randomly dispersed locations, using the Kinect system.
Three testing bubbles will be tested in the location where children need to reach about arm length overhead at 180, 135, and 90 degrees of shoulder abduction, with instructions for children to reach in two conditions: 1) as fast as possible, and 2) as accurate as possible.
Position data from the Kinect will be converted into 3-dimensional coordinate data and kinematic variables (movement time, trajectory straightness, speed, smoothness) will be computed.
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The end of the 6th week
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Reaching kinematics at the end of the 12th week
Time Frame: The end of the 12th week
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Reaching kinematics will be assessed while the child is interacting with Super Pop VRTM, wherein virtual bubbles are projected onto the TV in randomly dispersed locations, using the Kinect system.
Three testing bubbles will be tested in the location where children need to reach about arm length overhead at 180, 135, and 90 degrees of shoulder abduction, with instructions for children to reach in two conditions: 1) as fast as possible, and 2) as accurate as possible.
Position data from the Kinect will be converted into 3-dimensional coordinate data and kinematic variables (movement time, trajectory straightness, speed, smoothness) will be computed.
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The end of the 12th week
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Fine motor domain of Peabody Developmental Motor Scales-2nd edition at baseline
Time Frame: At baseline
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At baseline
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Fine motor domain of Peabody Developmental Motor Scales-2nd edition at the end of the 6th week
Time Frame: The end of the 6th week
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The end of the 6th week
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Fine motor domain of Peabody Developmental Motor Scales-2nd edition at the end of the 12th week
Time Frame: The end of the 12th week
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The end of the 12th week
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Daily use of affected hand at baseline
Time Frame: At baseline
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Daily use of affected hand will be evaluated using Revised Pediatric Motor Activity Log (R-PMAL), which is filled by primary caregivers about how often and how well their children use the affected arm in daily activities.
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At baseline
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Daily use of affected hand at the end of the 6th week
Time Frame: The end of the 6th week
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Daily use of affected hand will be evaluated using Revised Pediatric Motor Activity Log (R-PMAL), which is filled by primary caregivers about how often and how well their children use the affected arm in daily activities.
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The end of the 6th week
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Daily use of affected hand at the end of the 12th week
Time Frame: The end of the 12th week
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Daily use of affected hand will be evaluated using Revised Pediatric Motor Activity Log (R-PMAL), which is filled by primary caregivers about how often and how well their children use the affected arm in daily activities.
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The end of the 12th week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle strength at baseline
Time Frame: At baseline
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Muscle strength of shoulder flexion, extension, abductor, adduction, external rotation, and international rotation, elbow flexion and extension, and wrist flexion and extension will be measured using hand-held dynamometer prior and after intervention.
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At baseline
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Muscle strength at the end of the 6th week
Time Frame: The end of the 6th week
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Muscle strength of shoulder flexion, extension, abductor, adduction, external rotation, and international rotation, elbow flexion and extension, and wrist flexion and extension will be measured using hand-held dynamometer prior and after intervention.
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The end of the 6th week
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Muscle strength at the end of the 12th week
Time Frame: The end of the 12th week
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Muscle strength of shoulder flexion, extension, abductor, adduction, external rotation, and international rotation, elbow flexion and extension, and wrist flexion and extension will be measured using hand-held dynamometer prior and after intervention.
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The end of the 12th week
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Children's motivation and compliance
Time Frame: During the 12 weeks of intervention
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Children's motivation and compliance to the intervention will also be evaluated using the daily activity training log.
The primary caregiver will be asked to keep an activity training log to record their child's training activity, including the daily training and the total time when the child takes part in the training.
The total duration of performing the VR or conventional program will be calculated as the measure of compliance.
The investigators will ask caregivers to record the reasons for not completing the daily training.
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During the 12 weeks of intervention
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Yuping Chen, ScD, PT, Department of Physical Therapy, Georgia State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H21384
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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