Trial Outcomes & Findings for Motivating Occupational Virtual Experiences In Therapy for Kids (NCT NCT04510857)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

Pre-intervention at Baseline

Results posted on

2025-10-15

Participant Flow

Only children were considered enrolled in the study. A parent or legal guardian provided permission and the child verbal assented. Of the subjects enrolled, 2 failed screening tests (described in the protocol) and 2 others dropped out prior to randomization due to medical or personal reasons.

Participant milestones

Participant milestones
Measure	MOVE-IT Home Exercise Program (HEP) 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. MOVE-IT Intervention: The MOVE-IT device comprises a custom smart toy and therapy game software to enable repetitive task practice involving the arm and hand.	Usual Care Treatment (UCT) Control 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. UCT Control: Participants assigned to the UCT control group will continue to receive their previously prescribed therapy services.
Overall Study STARTED	11	10
Overall Study COMPLETED	10	8
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	MOVE-IT Home Exercise Program (HEP) 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. MOVE-IT Intervention: The MOVE-IT device comprises a custom smart toy and therapy game software to enable repetitive task practice involving the arm and hand.	Usual Care Treatment (UCT) Control 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. UCT Control: Participants assigned to the UCT control group will continue to receive their previously prescribed therapy services.
Overall Study Withdrawal by Subject	1	2

Baseline Characteristics

Motivating Occupational Virtual Experiences In Therapy for Kids

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MOVE-IT Home Exercise Program (HEP) n=11 Participants 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. MOVE-IT Intervention: The MOVE-IT device comprises a custom smart toy and therapy game software to enable repetitive task practice involving the arm and hand.	Usual Care Treatment (UCT) Control n=10 Participants 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. UCT Control: Participants assigned to the UCT control group will continue to receive their previously prescribed therapy services.	Total n=21 Participants Total of all reporting groups
Age, Continuous	9 years n=5 Participants	6.5 years n=7 Participants	8.5 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	10 participants n=7 Participants	21 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MOVE-IT Home Exercise Program (HEP) n=10 Participants 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. MOVE-IT Intervention: The MOVE-IT device comprises a custom smart toy and therapy game software to enable repetitive task practice involving the arm and hand.	Usual Care Treatment (UCT) Control n=8 Participants 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. UCT Control: Participants assigned to the UCT control group will continue to receive their previously prescribed therapy services.
Pre Jebsen Taylor Hand Function Test (JTHFT)	433.9 seconds Standard Deviation 225.1	294.7 seconds Standard Deviation 217.3

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MOVE-IT Home Exercise Program (HEP) n=10 Participants 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. MOVE-IT Intervention: The MOVE-IT device comprises a custom smart toy and therapy game software to enable repetitive task practice involving the arm and hand.	Usual Care Treatment (UCT) Control n=8 Participants 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. UCT Control: Participants assigned to the UCT control group will continue to receive their previously prescribed therapy services.
Post Jebsen Taylor Hand Function Test (JTHFT)	416.6 seconds Standard Deviation 228.9	268.3 seconds Standard Deviation 212.4

SECONDARY outcome

Timeframe: Pre-intervention at Baseline

Population: PMAL data were missing for one UCT subject.

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.

Outcome measures

Outcome measures
Measure	MOVE-IT Home Exercise Program (HEP) n=10 Participants 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. MOVE-IT Intervention: The MOVE-IT device comprises a custom smart toy and therapy game software to enable repetitive task practice involving the arm and hand.	Usual Care Treatment (UCT) Control n=7 Participants 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. UCT Control: Participants assigned to the UCT control group will continue to receive their previously prescribed therapy services.
Pre Pediatric Motor Activity Log (Amount)	1.68 score on a scale Standard Deviation 0.60	2.30 score on a scale Standard Deviation 0.93

SECONDARY outcome

Timeframe: Post Intervention at 10 weeks

Population: PMAL data were missing for one UCT subject.

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.

Outcome measures

Outcome measures
Measure	MOVE-IT Home Exercise Program (HEP) n=10 Participants 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. MOVE-IT Intervention: The MOVE-IT device comprises a custom smart toy and therapy game software to enable repetitive task practice involving the arm and hand.	Usual Care Treatment (UCT) Control n=7 Participants 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. UCT Control: Participants assigned to the UCT control group will continue to receive their previously prescribed therapy services.
Post Pediatric Motor Activity Log (Amount)	1.80 score on a scale Standard Deviation 0.73	2.23 score on a scale Standard Deviation 0.93

SECONDARY outcome

Timeframe: Pre-intervention at Baseline

Population: PMAL data were missing for one UCT subject.

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.

Outcome measures

Outcome measures
Measure	MOVE-IT Home Exercise Program (HEP) n=10 Participants 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. MOVE-IT Intervention: The MOVE-IT device comprises a custom smart toy and therapy game software to enable repetitive task practice involving the arm and hand.	Usual Care Treatment (UCT) Control n=7 Participants 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. UCT Control: Participants assigned to the UCT control group will continue to receive their previously prescribed therapy services.
Pre Pediatric Motor Activity Log (How Well)	1.68 score on a scale Standard Deviation 0.95	2.73 score on a scale Standard Deviation 0.88

SECONDARY outcome

Timeframe: Post Intervention at 10 weeks

Population: PMAL data were missing for one UCT subject.

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.

Outcome measures

Outcome measures
Measure	MOVE-IT Home Exercise Program (HEP) n=10 Participants 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. MOVE-IT Intervention: The MOVE-IT device comprises a custom smart toy and therapy game software to enable repetitive task practice involving the arm and hand.	Usual Care Treatment (UCT) Control n=7 Participants 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. UCT Control: Participants assigned to the UCT control group will continue to receive their previously prescribed therapy services.
Post Pediatric Motor Activity Log (How Well)	2.25 score on a scale Standard Deviation 0.73	2.98 score on a scale Standard Deviation 0.66

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MOVE-IT Home Exercise Program (HEP) n=10 Participants 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. MOVE-IT Intervention: The MOVE-IT device comprises a custom smart toy and therapy game software to enable repetitive task practice involving the arm and hand.	Usual Care Treatment (UCT) Control n=8 Participants 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. UCT Control: Participants assigned to the UCT control group will continue to receive their previously prescribed therapy services.
Pre Intervention Wolf Motor Function Test Time (WMFT-TIME)	24.3 seconds Standard Deviation 17.2	18.3 seconds Standard Deviation 25.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MOVE-IT Home Exercise Program (HEP) n=10 Participants 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. MOVE-IT Intervention: The MOVE-IT device comprises a custom smart toy and therapy game software to enable repetitive task practice involving the arm and hand.	Usual Care Treatment (UCT) Control n=8 Participants 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. UCT Control: Participants assigned to the UCT control group will continue to receive their previously prescribed therapy services.
Post Intervention Wolf Motor Function Test Time (WMFT-TIME)	24.1 seconds Standard Deviation 18.7	24.9 seconds Standard Deviation 40.0

SECONDARY outcome

Timeframe: Pre-intervention at Baseline

Population: WMFT FA data were missing for one UCT subject.

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.

Outcome measures

Outcome measures
Measure	MOVE-IT Home Exercise Program (HEP) n=10 Participants 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. MOVE-IT Intervention: The MOVE-IT device comprises a custom smart toy and therapy game software to enable repetitive task practice involving the arm and hand.	Usual Care Treatment (UCT) Control n=7 Participants 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. UCT Control: Participants assigned to the UCT control group will continue to receive their previously prescribed therapy services.
Pre Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA)	2.95 score on a scale Standard Deviation 0.92	3.40 score on a scale Standard Deviation 0.79

SECONDARY outcome

Timeframe: Post Intervention at 10 weeks

Population: WMFT FA data were missing for one UCT subject.

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.

Outcome measures

Outcome measures
Measure	MOVE-IT Home Exercise Program (HEP) n=10 Participants 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. MOVE-IT Intervention: The MOVE-IT device comprises a custom smart toy and therapy game software to enable repetitive task practice involving the arm and hand.	Usual Care Treatment (UCT) Control n=7 Participants 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. UCT Control: Participants assigned to the UCT control group will continue to receive their previously prescribed therapy services.
Post Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA)	3.00 score on a scale Standard Deviation 0.83	3.63 score on a scale Standard Deviation 0.74

SECONDARY outcome

Timeframe: Pre-intervention at Baseline

Population: QUEST data were missing for 2 HEP subjects and 1 UCT subject.

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.

Outcome measures

Outcome measures
Measure	MOVE-IT Home Exercise Program (HEP) n=8 Participants 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. MOVE-IT Intervention: The MOVE-IT device comprises a custom smart toy and therapy game software to enable repetitive task practice involving the arm and hand.	Usual Care Treatment (UCT) Control n=7 Participants 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. UCT Control: Participants assigned to the UCT control group will continue to receive their previously prescribed therapy services.
Pre Quality of Upper Extremity Skills Test (QUEST)	67.5 score on a scale Standard Deviation 9.7	77.7 score on a scale Standard Deviation 8.5

SECONDARY outcome

Timeframe: Post Intervention at 10 weeks

Population: QUEST data were missing for 2 HEP subjects and 1 UCT subject.

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.

Outcome measures

Outcome measures
Measure	MOVE-IT Home Exercise Program (HEP) n=8 Participants 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. MOVE-IT Intervention: The MOVE-IT device comprises a custom smart toy and therapy game software to enable repetitive task practice involving the arm and hand.	Usual Care Treatment (UCT) Control n=7 Participants 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. UCT Control: Participants assigned to the UCT control group will continue to receive their previously prescribed therapy services.
Post Quality of Upper Extremity Skills Test (QUEST)	65.3 score on a scale Standard Deviation 9.7	77.4 score on a scale Standard Deviation 10.8

Adverse Events

MOVE-IT Home Exercise Program (HEP)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care Treatment (UCT) Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Richard Adams

Barron Associates, Inc.

Phone: 4348253435

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place