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Completed

NCT Number: NCT04510857

Motivating Occupational Virtual Experiences In Therapy for Kids

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.

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Key information

Conditions

Virtual Reality Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases Occupational Therapy

Age range

4 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University, Durham, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

MOVE-IT Intervention

Device

The MOVE-IT device comprises a custom smart toy and therapy game software to enable repetitive task practice involving the arm and hand.

UCT Control

Behavioral

Participants assigned to the UCT control group will continue to receive their previously prescribed therapy services.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Pre Pediatric Motor Activity Log (Amount)

    Time frame: Pre-intervention at Baseline

    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.

  2. Post Pediatric Motor Activity Log (Amount)

    Time frame: Post Intervention at 10 weeks

    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.

  3. Pre Pediatric Motor Activity Log (How Well)

    Time frame: Pre-intervention at Baseline

    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.

  4. Post Pediatric Motor Activity Log (How Well)

    Time frame: Post Intervention at 10 weeks

    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.

  5. Pre Intervention Wolf Motor Function Test Time (WMFT-TIME)

    Time frame: Pre-intervention at Baseline

    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.

  6. Post Intervention Wolf Motor Function Test Time (WMFT-TIME)

    Time frame: Post Intervention at 10 weeks

    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.

  7. Pre Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA)

    Time frame: Pre-intervention at Baseline

    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.

  8. Post Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA)

    Time frame: Post Intervention at 10 weeks

    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.

  9. Pre Quality of Upper Extremity Skills Test (QUEST)

    Time frame: Pre-intervention at Baseline

    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.

  10. Post Quality of Upper Extremity Skills Test (QUEST)

    Time frame: Post Intervention at 10 weeks

    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.

Sponsors and collaborators

Lead sponsor

Barron Associates, Inc.

Industry

Collaborators

  • Duke University
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • University of Virginia

Registry information

Official study title

Motivating Occupational Virtual Experiences In Therapy for Kids (MOVE-IT)

Acronym: MOVE-IT

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 12, 2020
Registry last updated
Oct 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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