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SuspendedNCT04147468Updated Aug 24, 2026

Functional Strength Training and Virtual Reality in Children With CP

An interventional study of Virtual Reality and Functional Strength Training in Cerebral Palsy, sponsored by Georgia State University. Suspended at 1 site in United States. Open to participants aged 6 Years to 30 Years. Per ClinicalTrials.gov, last updated 2026-08-24.

Sponsored by Georgia State University · Not applicable, Interventional, and Treatment

Why this study was suspended
The funding has expired in June 2022. This protocol will be active once more funding is secured.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
6 Years to 30 Years
Sex
All
01

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 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.

02

Conditions studied

  • Cerebral Palsy

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Keywords

  • Virtual Reality
  • Functional Strength Training
  • Arm Function
03

In context

Cerebral Palsy

1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.

This study's planned enrollment of 10 is below the median of 33 across 1,368 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Georgia State University is the lead sponsor of 52 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
10 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • OtherVirtual 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.

  • OtherFunctional 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.

06

What researchers measure

Primary outcomes

  1. Brain neuroplasticity

    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.

    Time frame: Change from pre-intervention to the end of intervention, an average of 6 weeks

  2. Reaching kinematics

    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.

    Time frame: Change from pre-intervention to the end of intervention, an average of 6 weeks

  3. Fine motor function

    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.

    Time frame: Change from pre-intervention to the end of intervention, an average of 6 weeks

  4. Daily use of affected hand

    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.

    Time frame: Change from pre-intervention to the end of intervention, an average of 6 weeks

Secondary outcomes

  1. Muscle strength

    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.

    Time frame: Change from pre-intervention to the end of intervention, an average of 6 weeks

  2. Spasticity

    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.

    Time frame: Change from pre-intervention to the end of intervention, an average of 6 weeks

07

Study locations

1 site
  • Georgia State University
    Atlanta, Georgia 30303, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04147468
Lead sponsor
Georgia State University
Collaborators
Georgia Institute of Technology
Responsible party
Yuping Chen (Associate Professor, Georgia State University) — Principal investigator
First posted
Nov 1, 2019
Start date
Aug 16, 2019
Primary completion
Jun 30, 2022
Completion
Aug 31, 2026 (estimated)
Last update
Aug 24, 2026

Study contacts

Yuping Chen, ScD, PT
principal investigator · Georgia State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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