Clinical trial NCT04147468: Functional Strength Training and Virtual Reality in Children With CP
Official title: Effectiveness of Functional Strength Training and Virtual Reality Games on Improving Arm Function in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Virtual Reality
Functional Strength Training
Arm Function
Lead sponsor: Georgia State University
Sponsor class: OTHER
Collaborators: name: Georgia Institute of Technology
First posted: 2019-11-01
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group will receive virtual reality; the other group will receive functional strength training
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Brain neuroplasticity
timeFrame: Change from pre-intervention to the end of intervention, an average of 6 weeks
measure: Reaching kinematics
timeFrame: Change from pre-intervention to the end of intervention, an average of 6 weeks
measure: Fine motor function
timeFrame: Change from pre-intervention to the end of intervention, an average of 6 weeks
measure: Daily use of affected hand
timeFrame: Change from pre-intervention to the end of intervention, an average of 6 weeks
Secondary outcomes:
measure: Muscle strength
timeFrame: Change from pre-intervention to the end of intervention, an average of 6 weeks
measure: Spasticity
timeFrame: Change from pre-intervention to the end of intervention, an average of 6 weeks
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Georgia State University
state: Georgia
Study officials:
affiliation: Georgia State University
name: Yuping Chen, ScD, PT
role: PRINCIPAL_INVESTIGATOR
References: