Functional Strength Training and Virtual Reality in Children With CP

• ClinicalTrials.gov Identifier: NCT04147468
• Recruitment Status: Suspended
• First Posted: November 1, 2019
• Last Update Posted: March 13, 2023
• Sponsor: Georgia State University
• Collaborator: Georgia Institute of Technology
• Information provided by (Responsible Party): Yuping Chen, Georgia State University

Study Description

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 as well as the neuroplasticity changes in the brain related to the level of improvement.

Ten children with spastic CP will be recruited to participate in this pilot study. Children will be randomized to receive either VR of FST for 60 minutes per session x 3 sessions per week x 6 weeks at their home. All children will be evaluated prior to and immediately after the intervention at their home for clinical tests and at CABI for the MRI measures. Brain imaging data and clinical outcome measures including reaching kinematics, standardized fine motor assessment tool (Peabody Developmental Motor Scale-2nd edition), and daily use of affected hand (using Revised Pediatric Motor Activity Log) will be evaluated. A physical therapist who is blinded to the status will conduct the assessment.

The investigators anticipate children in both groups will improve their arm function after intervention; however, children in the VR group will have a better improvement as compared with children in the FST group.

Condition or disease	Intervention/treatment	Phase
Cerebral Palsy	Other: Virtual Reality; Other: Functional Strength Training	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: One group will receive virtual reality; the other group will receive functional strength training
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effectiveness of Functional Strength Training and Virtual Reality Games on Improving Arm Function in Children With Cerebral Palsy
• Actual Study Start Date: August 16, 2019
• Estimated Primary Completion Date: October 2025
• Estimated Study Completion Date: December 2025

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Virtual Reality Gaming Intervention; A newly developed VR gaming platform called Super Pop VR, a VR system that can be individualized to the movement capabilities of the child, will be used. The research team will loan the system to the family. The child will be asked to move their arms to 'pop' as many virtual objects as possible with the focus on outwards, upwards, and across midline.	Other: Virtual Reality; For the VR intervention, we 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 participant. The research team will travel to the family to conduct the intervention to ensure the treatment adherence. The participants will be asked to move their arms to 'pop' as many virtual objects as possible.
Experimental: Functional Strength Training; Children will receive 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 which are designed to move their arms.	Other: Functional Strength Training; For the functional strength training, participants will receive repetitive progressive resistance exercise during goal-directed functional activity with the participants focus on the activity being performed. The research team will also go to the family to conduct the FST intervention.

Outcome Measures

Primary Outcome Measures :

1. Brain neuroplasticity [ Time Frame: Change from pre-intervention to the end of intervention, an average of 6 weeks ]
   Brain images of primary sensorimotor cortex (SMC), the premotor cortex (PMC), and the supplementary motor area (SMA). During MRI measures, fMRI will be used to investigate cortical activation during a rest condition and 3 task conditions: 1) visually-guided wrist movement, 2) passively-guided wrist movement, and 3) imagined wrist movement. The same visual display will be shown to the participants in all conditions.
2. Reaching kinematics [ Time Frame: Change from pre-intervention to the end of intervention, an average of 6 weeks ]
   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. Children's reaching kinematics will also be assessed while playing the real-life functional activity by inserting an envelope into a mailbox slip located in neutral, outward 45, and inward 45 using the Kinect system. 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.
3. Fine motor function [ Time Frame: Change from pre-intervention to the end of intervention, an average of 6 weeks ]
   The fine motor domain of the Peabody Developmental Motor Scales, 2nd edition (PDMS-2) will be used. Two subsets of the Fine Motor Domain will be used to evaluate the children: grasping and visual-motor integration. Each item is rated as 0, 1, and 2 (0: child cannot attempt the item; 1: child's performance shows resemblance but not fully met the criteria; 2: child performs the item according to the criteria specified for mastery). Raw score will later be compared to the norm values and converted to percentile of the norm values.
4. Daily use of affected hand [ Time Frame: Change from pre-intervention to the end of intervention, an average of 6 weeks ]
   Daily use of affected hand will be evaluated using Revised Pediatric Motor Activity Log (R-PMAL), which is filled out by primary caregivers about how often and how well their children use the affected arm in daily activities.

Secondary Outcome Measures :

1. Muscle strength [ Time Frame: Change from pre-intervention to the end of intervention, an average of 6 weeks ]
   Muscle strength of shoulder flexion, extension, abductor, adduction, external rotation, and internal rotation, elbow flexion and extension, and wrist flexion and extension will be measured using hand-held dynamometer prior to and after intervention.
2. Spasticity [ Time Frame: Change from pre-intervention to the end of intervention, an average of 6 weeks ]
   Spasticity of shoulder flexion, extension, abduction, adduction, external rotation, and internal rotation, elbow flexion and extension, and wrist flexion and extension will also be measured using the Modified Ashworth Scale. It contains a scale of 0 to 4 with 0 as no spasticity to 4 as rigid in flexion or extension.

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 30 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• children with spastic CP are between ages 5-18 years; adults with spastic CP are between 19-30 years
• diagnosed with spastic 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 follow three-step commands
• 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, including MRI.

Exclusion Criteria:

• they 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, or
• if they have a severe attention deficit or uncontrolled epilepsy which may possibly be triggered by the light or sound of the virtual reality games.

Contacts and Locations

Locations

United States, Georgia

Georgia State University

Atlanta, Georgia, United States, 30303

Sponsors and Collaborators

Georgia State University

Georgia Institute of Technology

Investigators

• Principal Investigator: Yuping Chen, ScD, PT; Georgia State University

More Information

• Responsible Party: Yuping Chen, Associate Professor, Georgia State University
• ClinicalTrials.gov Identifier: NCT04147468
• Other Study ID Numbers: H17349
• First Posted: November 1, 2019
• Last Update Posted: March 13, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yuping Chen, Georgia State University:

Virtual Reality; Functional Strength Training; Arm Function

Additional relevant MeSH terms:

Cerebral Palsy; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases