Effect of Virtual Reality and Functional Strength Training on Arm Function in Children With Cerebral Palsy_2021
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cerebral Palsy
- Sponsor
- Georgia State University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Fine motor domain of Peabody Developmental Motor Scales-2nd edition at the end of the 6th week
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Yuping Chen
Professor
Georgia State University
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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
Daily use of affected hand at baseline
Time Frame: At baseline
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.
Daily use of affected hand at the end of the 6th week
Time Frame: The end of the 6th week
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.
Fine motor domain of Peabody Developmental Motor Scales-2nd edition at baseline
Time Frame: At baseline
Daily use of affected hand at the end of the 12th week
Time Frame: The end of the 12th week
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.
Reaching kinematics at the baseline
Time Frame: At baseline
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.
Reaching kinematics at the end of the 6th week
Time Frame: The end of the 6th week
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.
Reaching kinematics at the end of the 12th week
Time Frame: The end of the 12th week
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.
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
Secondary Outcomes
- Muscle strength at baseline(At baseline)
- Muscle strength at the end of the 6th week(The end of the 6th week)
- Muscle strength at the end of the 12th week(The end of the 12th week)
- Children's motivation and compliance(During the 12 weeks of intervention)