Cerebral PalsyNCT05494905
Virtual Reality vs Functional Strength Training in Children With Cerebral Palsy
A study testing VR and FST in people with Cerebral Palsy, run by Georgia State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- VR and FST
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 20 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Physical Therapy, Georgia State University
Atlanta, Georgia, 30303
About this study
Official title: Effect of Virtual Reality and Functional Strength Training on Arm Function in Children With Cerebral Palsy_2021
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
- Being tested
- VR, FST
- Keywords
- Cerebral Palsy, Virtual Reality, Functional Strength Training
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VROther
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.
FSTOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality (VR) | Experimental | Not described Receives: Other: VR |
| Functional Strength Training (FST) | Active comparator | Not described Receives: Other: FST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaching kinematics at the baseline
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, with instructions for children to reach in two conditions: 1) as fast as possible, and 2) as accurate as possible. 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.
Measured: At baseline
Reaching kinematics at the end of the 6th week
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, with instructions for children to reach in two conditions: 1) as fast as possible, and 2) as accurate as possible. 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.
Measured: The end of the 6th week
Reaching kinematics at the end of the 12th week
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, with instructions for children to reach in two conditions: 1) as fast as possible, and 2) as accurate as possible. 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.
Measured: The end of the 12th week
Fine motor domain of Peabody Developmental Motor Scales-2nd edition at baseline
Measured: At baseline
Fine motor domain of Peabody Developmental Motor Scales-2nd edition at the end of the 6th week
Measured: The end of the 6th week
Fine motor domain of Peabody Developmental Motor Scales-2nd edition at the end of the 12th week
Measured: The end of the 12th week
Daily use of affected hand at baseline
Daily use of affected hand will be evaluated using Revised Pediatric Motor Activity Log (R-PMAL), which is filled by primary caregivers about how often and how well their children use the affected arm in daily activities.
Measured: At baseline
Daily use of affected hand at the end of the 6th week
Daily use of affected hand will be evaluated using Revised Pediatric Motor Activity Log (R-PMAL), which is filled by primary caregivers about how often and how well their children use the affected arm in daily activities.
Measured: The end of the 6th week
Daily use of affected hand at the end of the 12th week
Daily use of affected hand will be evaluated using Revised Pediatric Motor Activity Log (R-PMAL), which is filled by primary caregivers about how often and how well their children use the affected arm in daily activities.
Measured: The end of the 12th week
Secondary outcomes (4)
Muscle strength at baseline
Muscle strength of shoulder flexion, extension, abductor, adduction, external rotation, and international rotation, elbow flexion and extension, and wrist flexion and extension will be measured using hand-held dynamometer prior and after intervention.
Measured: At baseline
Muscle strength at the end of the 6th week
Muscle strength of shoulder flexion, extension, abductor, adduction, external rotation, and international rotation, elbow flexion and extension, and wrist flexion and extension will be measured using hand-held dynamometer prior and after intervention.
Measured: The end of the 6th week
Muscle strength at the end of the 12th week
Muscle strength of shoulder flexion, extension, abductor, adduction, external rotation, and international rotation, elbow flexion and extension, and wrist flexion and extension will be measured using hand-held dynamometer prior and after intervention.
Measured: The end of the 12th week
Children's motivation and compliance
Children's motivation and compliance to the intervention will also be evaluated using the daily activity training log. The primary caregiver will be asked to keep an activity training log to record their child's training activity, including the daily training and the total time when the child takes part in the training. The total duration of performing the VR or conventional program will be calculated as the measure of compliance. The investigators will ask caregivers to record the reasons for not completing the daily training.
Measured: During the 12 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start1 Feb 2017
- Primary completion20 Jan 2026
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgia State University
- Sponsor type
- University, hospital or other
- Collaborators
- Georgia Institute of Technology
- Responsible party
- Principal investigator, Yuping Chen, Georgia State University
- Investigators
- Yuping Chen, ScD, PT, Principal investigator, Department of Physical Therapy, Georgia State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494905
- Sponsor's protocol ID
- H21384
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2022
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality and Functional Strength Training on Arm Function in Children With Cerebral Palsy_2021
- ClinicalTrials.gov ID
- NCT05494905
- Acronym / sponsor ID
- H21384
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Virtual Reality, Functional Strength Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Georgia State UniversityUniversity, hospital or other
- Collaborators
- Georgia Institute of Technology
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 20 Jan 2026 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 10 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality (VR) | Experimental | Other: VR |
| Functional Strength Training (FST) | Active comparator | Other: FST |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VRIn 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. | Other | Virtual Reality (VR) |
| FSTFST 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. | Other | Functional Strength Training (FST) |
Primary outcome
Reaching kinematics at the baseline
Time frame: At baseline
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, with instructions for children to reach in two conditions: 1) as fast as possible, and 2) as accurate as possible. 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.
Reaching kinematics at the end of the 6th week
Time frame: The end of the 6th week
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, with instructions for children to reach in two conditions: 1) as fast as possible, and 2) as accurate as possible. 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.
Reaching kinematics at the end of the 12th week
Time frame: The end of the 12th week
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, with instructions for children to reach in two conditions: 1) as fast as possible, and 2) as accurate as possible. 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.
Fine motor domain of Peabody Developmental Motor Scales-2nd edition at baseline
Time frame: At baseline
Fine motor domain of Peabody Developmental Motor Scales-2nd edition at the end of the 6th week
Time frame: The end of the 6th week
Fine motor domain of Peabody Developmental Motor Scales-2nd edition at the end of the 12th week
Time frame: The end of the 12th week
Daily use of affected hand at baseline
Time frame: At baseline
Daily use of affected hand will be evaluated using Revised Pediatric Motor Activity Log (R-PMAL), which is filled by primary caregivers about how often and how well their children use the affected arm in daily activities.
Daily use of affected hand at the end of the 6th week
Time frame: The end of the 6th week
Daily use of affected hand will be evaluated using Revised Pediatric Motor Activity Log (R-PMAL), which is filled by primary caregivers about how often and how well their children use the affected arm in daily activities.
Daily use of affected hand at the end of the 12th week
Time frame: The end of the 12th week
Daily use of affected hand will be evaluated using Revised Pediatric Motor Activity Log (R-PMAL), which is filled by primary caregivers about how often and how well their children use the affected arm in daily activities.
4 secondary outcomes
Muscle strength at baseline
Time frame: At baseline
Muscle strength at the end of the 6th week
Time frame: The end of the 6th week
Muscle strength at the end of the 12th week
Time frame: The end of the 12th week
Children's motivation and compliance
Time frame: During the 12 weeks of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy
Not yet recruitingObservational study
Changes in Land-Based Motor Function After Routine Hydrotherapy in Children With Cerebral Palsy
Cerebral Palsy
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
Not yet recruiting
EFFECT OF ROBOTIC GLOVES TRAINING ON UPPER LIMB COORDINATION, SELECTIVE MOTOR CONTROL AND ACTIVITIES OF DAILY LIVING IN CHILDREN WITH HEMIPARETIC CEREBRAL PALSY.
Hemiplegic Cerebral Palsy
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
Recruiting
Combined Popliteal and Adductor Canal Blocks for Postoperative Analgesia in Children With Cerebral Palsy
Cerebral Palsy, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuping Chen, ScD, PT principal investigator
Department of Physical Therapy, Georgia State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR and FST in people with Cerebral Palsy, run by Georgia State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reaching kinematics at the baseline (time frame: At baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.