Virtual Reality vs Functional Strength Training in Children With Cerebral Palsy

NCT ID: NCT05494905

Last Updated: 2023-12-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2024-12-31

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.

Conditions

Cerebral Palsy

Keywords

Cerebral Palsy; Virtual Reality; Functional Strength Training

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Virtual Reality (VR)

Group Type: EXPERIMENTAL

VR

Intervention Type: OTHER

In this project, the investigators 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 child. It consists of the Microsoft Kinect camera, a laptop, software, and TV screen. The research team will loan the system to the family. While engaged with the game, the child is immersed in a virtual world where virtual objects appear on the screen surrounding the child. Children are asked to move their arms to 'pop' as many virtual objects as possible in a certain amount of time. Playstation 2 EyeToy and EyeToy 2 games will also be used to increase children's motivation by playing a variety of different VR games.

Functional Strength Training (FST)

Group Type: ACTIVE_COMPARATOR

FST

Intervention Type: OTHER

FST involves 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 and these exercises are designed to move the more affected arm in overhead, outward, and across midline directions. Each exercise will be embedded in a game-like activity. Children will start with no resistance and gradually add on resistance using elastic bands or weight cuffs.

Interventions

VR

In this project, the investigators 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 child. It consists of the Microsoft Kinect camera, a laptop, software, and TV screen. The research team will loan the system to the family. While engaged with the game, the child is immersed in a virtual world where virtual objects appear on the screen surrounding the child. Children are asked to move their arms to 'pop' as many virtual objects as possible in a certain amount of time. Playstation 2 EyeToy and EyeToy 2 games will also be used to increase children's motivation by playing a variety of different VR games.

Intervention Type: OTHER

FST

FST involves 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 and these exercises are designed to move the more affected arm in overhead, outward, and across midline directions. Each exercise will be embedded in a game-like activity. Children will start with no resistance and gradually add on resistance using elastic bands or weight cuffs.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Georgia Institute of Technology

OTHER

Sponsor Role: collaborator

Georgia State University

OTHER

Sponsor Role: lead

Responsible Party

Yuping Chen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yuping Chen, ScD, PT

Role: PRINCIPAL_INVESTIGATOR

Department of Physical Therapy, Georgia State University

Locations

Department of Physical Therapy, Georgia State University

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Yuping Chen, ScD, PT

Role: CONTACT

Phone: 1-404-413-1256

Email: ypchen@gsu.edu

Facility Contacts

Yuping Chen, ScD, PT

Role: primary

Other Identifiers

H21384

Identifier Type: -

Identifier Source: org_study_id