Virtual RealityMOVE-ITNCT04510857
Motivating Occupational Virtual Experiences In Therapy for Kids
A study testing MOVE-IT Intervention in people with Virtual Reality and Occupational Therapy, run by Barron Associates, Inc. at 2 sites in United States.
Trial summary
A rater-blinded randomized controlled trial (RCT) will be conducted to compare the efficacy of MOVE-IT use in a remotely supervised home exercise program (HEP) to usual care for recovery of upper extremity (UE) function in children with hemiplegia. Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Virtual Reality, Occupational Therapy
- What is being tested?
- MOVE-IT Intervention
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Jun 2022to 15 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 4 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of hemiplegia resulting from cerebral palsy, stroke, or other form of brain injury;
- Medically stable;
- Participant has antigravity strength in the affected UE at the elbow to at least 45 degrees of active flexion;
- Participant has antigravity shoulder strength in the affected UE to at least 30 degrees each in active flexion, abduction/adduction, and 15 degrees in active internal/external rotation when in an upright and seated position;
- Participant has ability to perform a basic color-matching test and identify characters on a vision chart;
- Participant must be available to attend study visits during an approximately 3-week participation period;
- Willingness and ability to comply with scheduled visits and study procedures.
Who cannot join
- History of uncontrolled seizures;
- Has received another form of intensive UE therapy, such as CIMT, within the prior 6 months;
- Unwillingness or inability to understand or follow verbal directions;
- Diagnosis of moderate to severe cortical-visual impairment that in the judgement of the Principal Investigator could adversely impact the subject's participation;
- Psychological diagnosis that in the determination of the Principal Investigator could significantly impact subject's participation or that could be aggravated by study participation;
- Determination that participation would result in over exertion, or significant discomfort or pain;
- Determination that participation would result in significant agitation or elevated stress;
- Visual field deficit in either eye that impairs the ability to view the computer monitor.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Virginia (UVA)
Charlottesville, Virginia, 22908
Duke University
Durham, North Carolina, 27705
About this study
Official title: Motivating Occupational Virtual Experiences In Therapy for Kids (MOVE-IT)
A rater-blinded randomized controlled trial (RCT) will be conducted to compare the efficacy of MOVE-IT use in a remotely supervised home exercise program (HEP) to usual care for recovery of upper extremity (UE) function in children with hemiplegia.
Read the detailed description
A rater-blinded randomized controlled trial (RCT) will be conducted to compare the efficacy of MOVE-IT use in a remotely supervised home exercise program (HEP) to usual care for recovery of upper extremity (UE) function in children with hemiplegia, and to acquire evidence of usability and acceptance of the MOVE-IT system by children and parents. The University of Virginia (UVA) will serve as coordinating center and single IRB for the two-site RCT that includes UVA and Duke University.
The primary Phase II investigational objective is to show a differential effect on the pre- to post-intervention change in UE motor function between an interventional group receiving the MOVE-IT HEP and a usual care treatment (UCT) group, as assessed by the Jebsen Tailor Hand Function Test (JTHFT), a time-based measure of functional hand motor skills, and other gold-standard clinical instruments for UE function including the Quality of Upper Extremity Skills Test (QUEST), with qualitative assessment of discrete movements, and the Wolf Motor Function Test (WMFT), which includes both quantitative and qualitative assessment of functional movements.
The pre-to-post intervention change in the composite JTHFT score will be the primary endpoint for the Phase II efficacy study. Secondary analysis will include pre-to-post intervention changes in the composite QUEST and WMFT scores.
- Conditions
- Virtual Reality, Occupational Therapy
- Being tested
- MOVE-IT Intervention, UCT Control
- Keywords
- Cerebral palsy, Occupational therapy, Virtual reality, Therapy games, Pediatric hemiplegia, Teletherapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOVE-IT InterventionDevice
The MOVE-IT device comprises a custom smart toy and therapy game software to enable repetitive task practice involving the arm and hand.
UCT ControlBehavioural
Participants assigned to the UCT control group will continue to receive their previously prescribed therapy services.
| Study group | Role | What they receive |
|---|---|---|
| MOVE-IT Home Exercise Program (HEP) | Experimental | Participants will be asked to employ the MOVE-IT system for upper extremity practice at home 1 hour/day, 5 days/week over a 10-week period. Receives: Device: MOVE-IT Intervention |
| Usual Care Treatment (UCT) Control | Active comparator | Children in the UCT group will be followed as they continue to receive their previously prescribed therapy services. These children will not receive any treatment services through the study as UCT group participants. Receives: Behavioral: UCT Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre Jebsen Taylor Hand Function Test (JTHFT)
The JTHFT assesses hand function through timed movements such as simulated page turning, eating, stacking objects, and lifting objects of different size and mass. The JTHFT total score is simply the sum of all timed movements (in seconds). A lower score represents a better outcome.
Measured: Pre-intervention at Baseline
Post Jebsen Taylor Hand Function Test (JTHFT)
The JTHFT assesses hand function through timed movements such as simulated page turning, eating, stacking objects, and lifting objects of different size and mass. The JTHFT total score is simply the sum of all timed movements (in seconds). A lower score represents a better outcome.
Measured: Post Intervention at 10 weeks
Secondary outcomes (10)
Pre Pediatric Motor Activity Log (Amount)
The Pediatric Motor Activity Log (Amount) is a parent-reported assessment tool designed to evaluate the frequency of use of a child's affected (weaker) upper limb during 22 specific daily activities, such as reaching, grasping, or manipulating objects. For each activity, parents rate how often the child uses their affected arm on a 6-point Likert scale, ranging from 0 to 5. A score of 0 indicates that the child never uses the weaker arm for the activity (or the activity is not performed), while a score of 5 indicates that the weaker arm is used as frequently as the stronger arm for that activity. The reported score is the average of the individual scores for the 22 activities. A higher score represents a better outcome.
Measured: Pre-intervention at Baseline
Post Pediatric Motor Activity Log (Amount)
The Pediatric Motor Activity Log (Amount) is a parent-reported assessment tool designed to evaluate the frequency of use of a child's affected (weaker) upper limb during 22 specific daily activities, such as reaching, grasping, or manipulating objects. For each activity, parents rate how often the child uses their affected arm on a 6-point Likert scale, ranging from 0 to 5. A score of 0 indicates that the child never uses the weaker arm for the activity (or the activity is not performed), while a score of 5 indicates that the weaker arm is used as frequently as the stronger arm for that activity. The reported score is the average of the individual scores for the 22 activities. A higher score represents a better outcome.
Measured: Post Intervention at 10 weeks
Pre Pediatric Motor Activity Log (How Well)
The Preschool Pediatric Motor Activity Log (PMAL-How Well) is a parent-reported assessment tool designed to evaluate the quality of use of a child's affected upper limb (weaker arm) during 22 specific daily activities. For each activity, the parent rates the quality of their child's performance using the affected arm on a 6-point Likert scale, ranging from 0 to 5. A score of 0 indicates that the child does not use the weaker arm at all for the activity (or the activity is not performed), while a score of 5 indicates that the weaker arm is used as effectively as the stronger arm, with normal or near-normal quality of movement. The reported score is the average of the individual scores for the 22 activities. A higher score represents a better outcome.
Measured: Pre-intervention at Baseline
Post Pediatric Motor Activity Log (How Well)
The Preschool Pediatric Motor Activity Log (PMAL-How Well) is a parent-reported assessment tool designed to evaluate the quality of use of a child's affected upper limb (weaker arm) during 22 specific daily activities. For each activity, the parent rates the quality of their child's performance using the affected arm on a 6-point Likert scale, ranging from 0 to 5. A score of 0 indicates that the child does not use the weaker arm at all for the activity (or the activity is not performed), while a score of 5 indicates that the weaker arm is used as effectively as the stronger arm, with normal or near-normal quality of movement. The reported score is the average of the individual scores for the 22 activities. A higher score represents a better outcome.
Measured: Post Intervention at 10 weeks
Pre Intervention Wolf Motor Function Test Time (WMFT-TIME)
The WMFT test is a functionally-oriented clinical and research instrument. The test consists of 15 motor tasks scored both for time and quality of movement. WMFT-TIME is a quantitative measure calculated using the average time to complete the tasks. Any time greater than 120 seconds is recorded as 120 seconds. A patient's WMFT-TIME score (average completion time) thus ranges from 0 to 120. A reduction in WMFT-TIME implies improved motor function.
Measured: Pre-intervention at Baseline
Post Intervention Wolf Motor Function Test Time (WMFT-TIME)
The WMFT test is a functionally-oriented clinical and research instrument. The test consists of 15 motor tasks scored both for time and quality of movement. WMFT-TIME is a quantitative measure calculated using the average time to complete the tasks. Any time greater than 120 seconds is recorded as 120 seconds. A patient's WMFT-TIME score (average completion time) thus ranges from 0 to 120. A reduction in WMFT-TIME implies improved motor function.
Measured: Post Intervention at 10 weeks
Pre Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA)
The WMFT test is a functionally-oriented clinical and research instrument. The test consists of 15 motor tasks scored both for time and quality of movement.
The WMFT Functional Assessment (WMFT-FA) score is an observational assessment of movement quality and scored using a 6-point ordinal rating scale that ranges from 0 (no use of the affected side attempted) to 5 (normal function). A total WMFT-FA score is calculated by taking the average across all 15 UE tasks. A patient's WMFT-FA score is thus a real number that can range from 0 to 5. An increase in WMFT-FA score implies improved motor function.
Measured: Pre-intervention at Baseline
Post Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA)
The WMFT test is a functionally-oriented clinical and research instrument. The test consists of 15 motor tasks scored both for time and quality of movement.
The WMFT Functional Assessment (WMFT-FA) score is an observational assessment of movement quality and scored using a 6-point ordinal rating scale that ranges from 0 (no use of the affected side attempted) to 5 (normal function). A total WMFT-FA score is calculated by taking the average across all 15 UE tasks. A patient's WMFT-FA score is thus a real number that can range from 0 to 5. An increase in WMFT-FA score implies improved motor function.
Measured: Post Intervention at 10 weeks
Pre Quality of Upper Extremity Skills Test (QUEST)
Quality of Upper Extremity Skills Test (QUEST) is a standardized assessment tool designed to evaluate upper extremity (UE) function in children with neuromotor disabilities, such as cerebral palsy. This study used only the dissociated movements and grasp function components of the QUEST instrument. Observational criteria were used to assign a value of 0, 1, or 2 for each of 44 items. Individual component scores were summed to create a total score with a range from 0 to 88. A higher value corresponds to a better outcome.
Measured: Pre-intervention at Baseline
Post Quality of Upper Extremity Skills Test (QUEST)
Quality of Upper Extremity Skills Test (QUEST) is a standardized assessment tool designed to evaluate upper extremity (UE) function in children with neuromotor disabilities, such as cerebral palsy. This study used only the dissociated movements and grasp function components of the QUEST instrument. Observational criteria were used to assign a value of 0, 1, or 2 for each of 44 items. Individual component scores were summed to create a total score with a range from 0 to 88. A higher value corresponds to a better outcome.
Measured: Post Intervention at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start17 Jun 2022
- Primary completion15 Jun 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Virtual RealityStudies 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
- Parallel groups
- Model description
- Intervention group performs home exercise program using the computer-aided MOVE-IT system for upper extremity therapy. Control group participants will be followed as they continue to receive their previously prescribed therapy services.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barron Associates, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Virginia, Duke University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510857
- Sponsor's protocol ID
- MOVE-IT
- Other IDs
- 5R44HD092169-03
- Acronym
- MOVE-IT
- Status last verified
- Sep 2025
- First submitted
- 9 Aug 2020
- Last updated
- 15 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivating Occupational Virtual Experiences In Therapy for Kids (MOVE-IT)
- ClinicalTrials.gov ID
- NCT04510857
- Acronym / sponsor ID
- MOVE-IT / MOVE-IT
- Conditions
- Virtual Reality, Occupational Therapy
- Keywords
- Cerebral palsy, Occupational therapy, Virtual reality, Therapy games, Pediatric hemiplegia, Teletherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Barron Associates, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Virginia, Duke University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 17 Jun 2022 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 12 Aug 2020 (actual)
- Results
- Posted 15 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A rater-blinded randomized controlled trial (RCT) will be conducted to compare the efficacy of MOVE-IT use in a remotely supervised home exercise program (HEP) to usual care for recovery of upper extremity (UE) function in children with hemiplegia.
Detailed description
A rater-blinded randomized controlled trial (RCT) will be conducted to compare the efficacy of MOVE-IT use in a remotely supervised home exercise program (HEP) to usual care for recovery of upper extremity (UE) function in children with hemiplegia, and to acquire evidence of usability and acceptance of the MOVE-IT system by children and parents. The University of Virginia (UVA) will serve as coordinating center and single IRB for the two-site RCT that includes UVA and Duke University.
The primary Phase II investigational objective is to show a differential effect on the pre- to post-intervention change in UE motor function between an interventional group receiving the MOVE-IT HEP and a usual care treatment (UCT) group, as assessed by the Jebsen Tailor Hand Function Test (JTHFT), a time-based measure of functional hand motor skills, and other gold-standard clinical instruments for UE function including the Quality of Upper Extremity Skills Test (QUEST), with qualitative assessment of discrete movements, and the Wolf Motor Function Test (WMFT), which includes both quantitative and qualitative assessment of functional movements.
The pre-to-post intervention change in the composite JTHFT score will be the primary endpoint for the Phase II efficacy study. Secondary analysis will include pre-to-post intervention changes in the composite QUEST and WMFT scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention group performs home exercise program using the computer-aided MOVE-IT system for upper extremity therapy. Control group participants will be followed as they continue to receive their previously prescribed therapy services.
| Arm | Type | Receives |
|---|---|---|
| MOVE-IT Home Exercise Program (HEP) | Experimental | Device: MOVE-IT InterventionParticipants will be asked to employ the MOVE-IT system for upper extremity practice at home 1 hour/day, 5 days/week over a 10-week period. |
| Usual Care Treatment (UCT) Control | Active comparator | Behavioral: UCT ControlChildren in the UCT group will be followed as they continue to receive their previously prescribed therapy services. These children will not receive any treatment services through the study as UCT group participants. |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Diagnosis of hemiplegia resulting from cerebral palsy, stroke, or other form of brain injury;
- Medically stable;
- Participant has antigravity strength in the affected UE at the elbow to at least 45 degrees of active flexion;
- Participant has antigravity shoulder strength in the affected UE to at least 30 degrees each in active flexion, abduction/adduction, and 15 degrees in active internal/external rotation when in an upright and seated position;
- Participant has ability to perform a basic color-matching test and identify characters on a vision chart;
Key exclusion criteria (8 listed)
- History of uncontrolled seizures;
- Has received another form of intensive UE therapy, such as CIMT, within the prior 6 months;
- Unwillingness or inability to understand or follow verbal directions;
- Diagnosis of moderate to severe cortical-visual impairment that in the judgement of the Principal Investigator could adversely impact the subject's participation;
- Psychological diagnosis that in the determination of the Principal Investigator could significantly impact subject's participation or that could be aggravated by study participation;
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 |
|---|---|---|
| MOVE-IT InterventionThe MOVE-IT device comprises a custom smart toy and therapy game software to enable repetitive task practice involving the arm and hand. | Device | MOVE-IT Home Exercise Program (HEP) |
| UCT ControlParticipants assigned to the UCT control group will continue to receive their previously prescribed therapy services. | Behavioural | Usual Care Treatment (UCT) Control |
Primary outcome
Pre Jebsen Taylor Hand Function Test (JTHFT)
Time frame: Pre-intervention at Baseline
The JTHFT assesses hand function through timed movements such as simulated page turning, eating, stacking objects, and lifting objects of different size and mass. The JTHFT total score is simply the sum of all timed movements (in seconds). A lower score represents a better outcome.
Post Jebsen Taylor Hand Function Test (JTHFT)
Time frame: Post Intervention at 10 weeks
The JTHFT assesses hand function through timed movements such as simulated page turning, eating, stacking objects, and lifting objects of different size and mass. The JTHFT total score is simply the sum of all timed movements (in seconds). A lower score represents a better outcome.
10 secondary outcomes
Pre Pediatric Motor Activity Log (Amount)
Time frame: Pre-intervention at Baseline
Post Pediatric Motor Activity Log (Amount)
Time frame: Post Intervention at 10 weeks
Pre Pediatric Motor Activity Log (How Well)
Time frame: Pre-intervention at Baseline
Post Pediatric Motor Activity Log (How Well)
Time frame: Post Intervention at 10 weeks
Pre Intervention Wolf Motor Function Test Time (WMFT-TIME)
Time frame: Pre-intervention at Baseline
Post Intervention Wolf Motor Function Test Time (WMFT-TIME)
Time frame: Post Intervention at 10 weeks
Pre Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA)
Time frame: Pre-intervention at Baseline
Post Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA)
Time frame: Post Intervention at 10 weeks
Pre Quality of Upper Extremity Skills Test (QUEST)
Time frame: Pre-intervention at Baseline
Post Quality of Upper Extremity Skills Test (QUEST)
Time frame: Post Intervention at 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOVE-IT Intervention in people with Virtual Reality and Occupational Therapy, run by Barron Associates, Inc. at 2 sites 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 7 inclusion and 8 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 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 15 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pre Jebsen Taylor Hand Function Test (JTHFT) (time frame: Pre-intervention at Baseline). The study lists 2 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 15 Oct 2025.