Clinical trial NCT05494905: Virtual Reality vs Functional Strength Training in Children With Cerebral Palsy
Official title: Effect of Virtual Reality and Functional Strength Training on Arm Function in Children With Cerebral Palsy_2021
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Virtual Reality
Functional Strength Training
Lead sponsor: Georgia State University
Sponsor class: OTHER
Collaborators: name: Georgia Institute of Technology
First posted: 2022-08-10
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: For the first six weeks of intervention, children will be randomly assigned to receive either VR or FST. After being determined as a respondent or non-respondent by the end of the first 6 weeks of the intervention, non-respondent children will be re-randomized to either receive the combination of FST and VR or switch to the other intervention (i.e., children who receive VR in the first 6 weeks will switch to FST; and verse versa).
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 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.


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.

Primary outcomes:
measure: Reaching kinematics at the baseline
timeFrame: At baseline
measure: Reaching kinematics at the end of the 6th week
timeFrame: The end of the 6th week
measure: Reaching kinematics at the end of the 12th week
timeFrame: The end of the 12th week
measure: Fine motor domain of Peabody Developmental Motor Scales-2nd edition at baseline
timeFrame: At baseline
measure: Fine motor domain of Peabody Developmental Motor Scales-2nd edition at the end of the 6th week
timeFrame: The end of the 6th week
measure: Fine motor domain of Peabody Developmental Motor Scales-2nd edition at the end of the 12th week
timeFrame: The end of the 12th week
measure: Daily use of affected hand at baseline
timeFrame: At baseline
measure: Daily use of affected hand at the end of the 6th week
timeFrame: The end of the 6th week
measure: Daily use of affected hand at the end of the 12th week
timeFrame: The end of the 12th week
Secondary outcomes:
measure: Muscle strength at baseline
timeFrame: At baseline
measure: Muscle strength at the end of the 6th week
timeFrame: The end of the 6th week
measure: Muscle strength at the end of the 12th week
timeFrame: The end of the 12th week
measure: Children's motivation and compliance
timeFrame: During the 12 weeks of intervention
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Department of Physical Therapy, Georgia State University
state: Georgia
Study officials:
affiliation: Department of Physical Therapy, Georgia State University
name: Yuping Chen, ScD, PT
role: PRINCIPAL_INVESTIGATOR
References: