Virtual Reality vs Functional Strength Training in Children With Cerebral Palsy

Last updated: December 12, 2023
Sponsor: Georgia State University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cataplexy

Cerebral Palsy

Treatment

VR

FST

Clinical Study ID

NCT05494905
H21384
  • Ages 5-17
  • All Genders

Study 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

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 allevaluation measurements.

Exclusion

Exclusion Criteria:

  • children have received surgery or botulinum toxin type A injection in the training armwithin the preceding 4 months or are scheduled to receive it during the planned studyperiod,
  • if children have a severe attention deficit or uncontrolled epilepsy which maypossibly be triggered by the light or sound of the video games.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: VR
Phase:
Study Start date:
February 01, 2017
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Department of Physical Therapy, Georgia State University

    Atlanta, Georgia 30303
    United States

    Active - Recruiting

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