Trial Outcomes & Findings for Use of Joystick-operated Ride-on-toys to Improve Affected Arm Use and Function in Children With Hemiplegic Cerebral Palsy (NCT NCT05559320)

NCT ID: NCT05559320

Last Updated: 2025-06-17

Results Overview

The Quality of Upper Extremity Skills Test (QUEST) is a criterion-referenced, valid, and reliable measure for use between 18 months-12 years to assesses quality of UE function in 4 domains: dissociated movement, grasp, protective extension, and weight bearing. The tool includes 36 items that evaluate movement patterns and hand function in children with CP and are scored on a dichotomous scale. Scores for each sub-domain and the total score are calculated as percentages. The total QUEST score was calculated by summing scores for each sub-domain tested divided by the total number of sub-domains tested. The total scores on the QUEST range from 0 to 100. Higher scores represent better quality of movement.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)
• Results posted on: 2025-06-17

Participant Flow

Participant milestones

Measure	Single Joystick Ride-on-car Navigation Training Participants will first participate in a 6-week control phase followed by a 6-week intervention phase. During the intervention phase, they will receive the ride-on-toy navigation training program. The training will be provided by the researchers twice a week, 30-45 minutes/session for 6 weeks. Caregivers will be asked to provide 2 additional sessions/week during the intervention phase. In this study design, the participants will serve as their own controls.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of Joystick-operated Ride-on-toys to Improve Affected Arm Use and Function in Children With Hemiplegic Cerebral Palsy

Baseline characteristics by cohort

Measure	Single Joystick Ride-on-car Navigation Training n=15 Participants Participants will first participate in a 6-week control phase followed by a 6-week intervention phase. During the intervention phase, they will receive the ride-on-toy navigation training program. The training will be provided by the researchers twice a week, 30-45 minutes/session for 6 weeks. Caregivers will be asked to provide 2 additional sessions/week during the intervention phase. In this study design, the participants will serve as their own controls.
Age, Categorical <=18 years	15 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	5.92 years STANDARD_DEVIATION 2.25 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)

The Quality of Upper Extremity Skills Test (QUEST) is a criterion-referenced, valid, and reliable measure for use between 18 months-12 years to assesses quality of UE function in 4 domains: dissociated movement, grasp, protective extension, and weight bearing. The tool includes 36 items that evaluate movement patterns and hand function in children with CP and are scored on a dichotomous scale. Scores for each sub-domain and the total score are calculated as percentages. The total QUEST score was calculated by summing scores for each sub-domain tested divided by the total number of sub-domains tested. The total scores on the QUEST range from 0 to 100. Higher scores represent better quality of movement.

Outcome measures

Measure	Single Joystick Ride-on-car Navigation Training n=15 Participants Participants will first participate in a 6-week control phase followed by a 6-week intervention phase. During the intervention phase, they will receive the ride-on-toy navigation training program. The training will be provided by the researchers twice a week, 30-45 minutes/session for 6 weeks. Caregivers will be asked to provide 2 additional sessions/week during the intervention phase. In this study design, the participants will serve as their own controls.
Change in Affected Arm Movement Control 12-weeks (i.e., at the end of intervention phase)	83.8 percentage Standard Error 2.2
Change in Affected Arm Movement Control Baseline	74.9 percentage Standard Error 3.1
Change in Affected Arm Movement Control 6-weeks (i.e., at the end of the control phase)	78.3 percentage Standard Error 3.5

PRIMARY outcome

Timeframe: Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)

The Shriner's Hospital Upper Extremity Evaluation (SHUEE) is a video-based assessment designed to assess spontaneous use and dynamic segmental alignment of the affected UE during functional tasks in children with hemiplegic CP between 3 and 18 years. The SHUEE includes 16 bimanual tasks. Of these 16 tasks, to assess the child's actual function of the affected UE a spontaneous use score is calculated during performance of 9 out of the 16 tasks. This Spontaneous Functional Analysis (SFA) score per task is rated on a scale of 0 to 5, where higher values indicate more spontaneous use of the affected UE. We summed the SFA scores across all 9 tasks, divided this sum by the total possible score, and then multiplied this value by 100 to express SFA as a percentage of normal or optimal score.

Outcome measures

Measure	Single Joystick Ride-on-car Navigation Training n=15 Participants Participants will first participate in a 6-week control phase followed by a 6-week intervention phase. During the intervention phase, they will receive the ride-on-toy navigation training program. The training will be provided by the researchers twice a week, 30-45 minutes/session for 6 weeks. Caregivers will be asked to provide 2 additional sessions/week during the intervention phase. In this study design, the participants will serve as their own controls.
Changes in Use of Affected Arm in Functional Activities Baseline	52.3 percentage of normal or optimal score Standard Error 3.4
Changes in Use of Affected Arm in Functional Activities 6-weeks (i.e., at the end of the control phase)	53.3 percentage of normal or optimal score Standard Error 3.4
Changes in Use of Affected Arm in Functional Activities 12-weeks (i.e., at the end of intervention phase)	60.7 percentage of normal or optimal score Standard Error 3.1

PRIMARY outcome

Timeframe: Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)

We will provide children with the Actigraph wrist activity monitors that can be worn like a wristwatch. Children will be asked to wear 2 wrist monitors, one each on both wrists, at 6 timepoints: (a) for one week at the pretest, (b) for one week at mid-point assessment, (c) during first week of training, (d) during last week of training, and (e) for one week at posttest. Children will be provided 2 watches during the pretest visit and they will be requested to wear the watches on both wrists for the next 1 week prior to the start of the training program. Children will be asked to wear the monitor continuously when awake and while sleeping for a minimum of 4 days - 1 weekend day and 3 weekdays.

Outcome measures

Measure	Single Joystick Ride-on-car Navigation Training n=12 Participants Participants will first participate in a 6-week control phase followed by a 6-week intervention phase. During the intervention phase, they will receive the ride-on-toy navigation training program. The training will be provided by the researchers twice a week, 30-45 minutes/session for 6 weeks. Caregivers will be asked to provide 2 additional sessions/week during the intervention phase. In this study design, the participants will serve as their own controls.
Changes in Habitual Arm Activity on the Affected Side Baseline	48.4 %time Mod-Vig Activity of Affected Side Standard Error 4.3
Changes in Habitual Arm Activity on the Affected Side at 6-weeks (i.e., at the end of the control phase)	50.9 %time Mod-Vig Activity of Affected Side Standard Error 5.0
Changes in Habitual Arm Activity on the Affected Side at 12-weeks (i.e., at the end of intervention phase)	50.4 %time Mod-Vig Activity of Affected Side Standard Error 3.5

PRIMARY outcome

Timeframe: at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)

Data will be collected during a unilateral and bilateral reach-grasp task at self-selected speed involving different objects (foam ball, rattle, and square block) placed at half arm's length (near) and at arm's length (far) on the table. Sensors (Inertial Measurement Units (IMUs)) will be placed on both hands, both forearms, both arms, and the C7 spinous process. We will assess range of motion of joints during upper extremity activities.

Outcome measures

Measure	Single Joystick Ride-on-car Navigation Training n=8 Participants Participants will first participate in a 6-week control phase followed by a 6-week intervention phase. During the intervention phase, they will receive the ride-on-toy navigation training program. The training will be provided by the researchers twice a week, 30-45 minutes/session for 6 weeks. Caregivers will be asked to provide 2 additional sessions/week during the intervention phase. In this study design, the participants will serve as their own controls.
Changes in Kinematic Measures of Movement Control on the Affected Arm Overhead shoulder ROM at 6-weeks (i.e., at the end of the control phase)	113.69 degrees Standard Error 6.53
Changes in Kinematic Measures of Movement Control on the Affected Arm Overhead shoulder ROM at 12-weeks (i.e., at the end of intervention phase)	123.93 degrees Standard Error 7.47
Changes in Kinematic Measures of Movement Control on the Affected Arm Elbow ROM at 6-weeks (i.e., at the end of the control phase)	112.68 degrees Standard Error 7.53
Changes in Kinematic Measures of Movement Control on the Affected Arm Elbow ROM at 12-weeks (i.e., at the end of intervention phase)	132.59 degrees Standard Error 7.08
Changes in Kinematic Measures of Movement Control on the Affected Arm Wrist Sagittal ROM at 6-weeks (i.e., at the end of the control phase)	58.72 degrees Standard Error 13.80
Changes in Kinematic Measures of Movement Control on the Affected Arm Wrist Sagittal ROM at 12-weeks (i.e., at the end of intervention phase)	69.78 degrees Standard Error 16.59

PRIMARY outcome

Timeframe: At 6-weeks (i.e., at the end of the control phase), at 12 weeks (i.e. following completion of the intervention phase)

Children will complete the valid and reliable 16-item Physical Activity Enjoyment Scale (PAES) to rate their experience with the intervention. The PAES includes a mix of 9 positively phrased (e.g., I enjoy it, It gives me energy, etc.) and 7 negatively phrased (e.g., I feel bored, It's no fun at all, etc.) questions that are rated on a 5-point Likert scale (1: Disagree a lot, 5 - Agree a lot). The negatively coded items were reverse coded and an average total score across all items was calculated. The PAES total score ranges from 1 to 5, with higher scores indicating greater levels of enjoyment with training activities.

Outcome measures

Measure	Single Joystick Ride-on-car Navigation Training n=14 Participants Participants will first participate in a 6-week control phase followed by a 6-week intervention phase. During the intervention phase, they will receive the ride-on-toy navigation training program. The training will be provided by the researchers twice a week, 30-45 minutes/session for 6 weeks. Caregivers will be asked to provide 2 additional sessions/week during the intervention phase. In this study design, the participants will serve as their own controls.
Treatment Satisfaction 6-weeks (i.e., at the end of the control phase)	3.7 score on a scale Standard Error 0.2
Treatment Satisfaction 12 weeks (i.e. following completion of the intervention phase)	3.9 score on a scale Standard Error 0.1

PRIMARY outcome

Timeframe: At 12 weeks (i.e. following completion of the intervention and control phases each lasting for 6 weeks)

Children and caregivers will fill out exit questionnaires to assess training satisfaction, enjoyment, repeatability, and caregiver burden.

Outcome measures

Measure	Single Joystick Ride-on-car Navigation Training n=15 Participants Participants will first participate in a 6-week control phase followed by a 6-week intervention phase. During the intervention phase, they will receive the ride-on-toy navigation training program. The training will be provided by the researchers twice a week, 30-45 minutes/session for 6 weeks. Caregivers will be asked to provide 2 additional sessions/week during the intervention phase. In this study design, the participants will serve as their own controls.
Perceived Satisfaction With Intervention number of children reporting high enjoyment	12 Participants
Perceived Satisfaction With Intervention number of caregivers agreeing RNT is overall beneficial	15 Participants

PRIMARY outcome

Timeframe: At 12 weeks (i.e. following completion of the intervention and control phases each lasting for 6 weeks)

Population: child and caregiver

Trainers will fill out posttest exit questionnaires to assess ease of implementation of the training program.

Outcome measures

Measure	Single Joystick Ride-on-car Navigation Training n=15 Participants Participants will first participate in a 6-week control phase followed by a 6-week intervention phase. During the intervention phase, they will receive the ride-on-toy navigation training program. The training will be provided by the researchers twice a week, 30-45 minutes/session for 6 weeks. Caregivers will be asked to provide 2 additional sessions/week during the intervention phase. In this study design, the participants will serve as their own controls.
Ease of Implementation of Training number of caregivers reporting some difficulty in independently delivering RNT	9 Participants
Ease of Implementation of Training number of children wanting to repeat RNT	14 Participants

PRIMARY outcome

Timeframe: Early (week 1), Mid (week 3), and late (week 6) training sessions within the 6-week intervention phase

An unbiased coder randomly coded video data (one each of early, mid, and late sessions) from researcher-delivered sessions within the intervention phase using a fidelity checklist to assess adherence to the training protocol. A 159-item fidelity checklist (total possible score: 159) specific to the training program was used for scoring treatment fidelity. Each item was rated on scale of 0 to 1, where 0 meant that the criterion was not satisfied and 1 meant that the fidelity criterion was satisfied. The total scores on the checklist could range from 0 to 159. We calculated a percent fidelity score by dividing the total score received by the total possible score (i.e., 159) and then multiplied this value by 100.

Outcome measures

Measure	Single Joystick Ride-on-car Navigation Training n=15 Participants Participants will first participate in a 6-week control phase followed by a 6-week intervention phase. During the intervention phase, they will receive the ride-on-toy navigation training program. The training will be provided by the researchers twice a week, 30-45 minutes/session for 6 weeks. Caregivers will be asked to provide 2 additional sessions/week during the intervention phase. In this study design, the participants will serve as their own controls.
Changes in Treatment Fidelity Across Training Weeks Early (week 1)	95.1 percentage of total possible score Standard Error 0.7
Changes in Treatment Fidelity Across Training Weeks Mid (week 3)	96.1 percentage of total possible score Standard Error 0.4
Changes in Treatment Fidelity Across Training Weeks Late (week 6)	95.6 percentage of total possible score Standard Error 0.7

PRIMARY outcome

Timeframe: From start to end of 6-week intervention phase on a weekly basis

Sensors mounted on the toy will collect data on amount of use (in minutes/week) of the toy during training weeks. We will assess toy use on a weekly basis across the training period.

Outcome measures

Measure	Single Joystick Ride-on-car Navigation Training n=12 Participants Participants will first participate in a 6-week control phase followed by a 6-week intervention phase. During the intervention phase, they will receive the ride-on-toy navigation training program. The training will be provided by the researchers twice a week, 30-45 minutes/session for 6 weeks. Caregivers will be asked to provide 2 additional sessions/week during the intervention phase. In this study design, the participants will serve as their own controls.
Changes in Toy Use (in Minutes/Week) Across Training Weeks Week 1 Duration	34.3 minutes Standard Error 3.6
Changes in Toy Use (in Minutes/Week) Across Training Weeks Week 2 Duration	41.5 minutes Standard Error 5.7
Changes in Toy Use (in Minutes/Week) Across Training Weeks Week 3 Duration	44.2 minutes Standard Error 5.1
Changes in Toy Use (in Minutes/Week) Across Training Weeks Week 4 Duration	40.4 minutes Standard Error 4.1
Changes in Toy Use (in Minutes/Week) Across Training Weeks Week 5 Duration	38.5 minutes Standard Error 5.5
Changes in Toy Use (in Minutes/Week) Across Training Weeks Week 6 Duration	60.4 minutes Standard Error 9.7

PRIMARY outcome

Timeframe: From start to end of 6-week intervention phase on a weekly basis

Researchers will also maintain training logs during the intervention phase to document # of training sessions completed out of the total possible sessions (12).

Outcome measures

Measure

Single Joystick Ride-on-car Navigation Training n=15 Participants Participants will first participate in a 6-week control phase followed by a 6-week intervention phase. During the intervention phase, they will receive the ride-on-toy navigation training program. The training will be provided by the researchers twice a week, 30-45 minutes/session for 6 weeks. Caregivers will be asked to provide 2 additional sessions/week during the intervention phase. In this study design, the participants will serve as their own controls.

# of Training Sessions Completed Assessed Using Training Logs

98.33 percentage of sessions attended Standard Error 1.21

SECONDARY outcome

Timeframe: Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)

The ABILHAND-Kids is a valid and reliable parent-rated questionnaire assessing parent perceptions of their child's level of ease or difficulty in performing 21 manual activities independently over the last 3 months. The questionnaire has been validated as a measure of manual ability for 6-16-year-old children with CP. The 21 manual activities are rated by parents on a 3-point scale of "impossible" (given a score of 0), "difficult" (given a score of 1), or "easy" (given a score of 2). ABILHAND score is expressed in logits, resulting from the conversion of the ordinal raw score into a linear measure of ability located on a unidimensional scale. The logit is a linear unit that expresses the odds of success of the patient on any given item. This unit is constant throughout the measurement scale. The manual ability scale is, by convention, centered on the average item difficulty (0 logit), the scale ranging from -6.75 to 6.68, with higher scores indicating better manual abilities.

Outcome measures

Measure	Single Joystick Ride-on-car Navigation Training n=15 Participants Participants will first participate in a 6-week control phase followed by a 6-week intervention phase. During the intervention phase, they will receive the ride-on-toy navigation training program. The training will be provided by the researchers twice a week, 30-45 minutes/session for 6 weeks. Caregivers will be asked to provide 2 additional sessions/week during the intervention phase. In this study design, the participants will serve as their own controls.
Changes in Parent-rated Scores on Functional Use of the Affected Arm Baseline	0.1 score on a scale Standard Error 0.4
Changes in Parent-rated Scores on Functional Use of the Affected Arm 6-weeks (i.e., at the end of the control phase)	0.5 score on a scale Standard Error 0.3
Changes in Parent-rated Scores on Functional Use of the Affected Arm 12-weeks (i.e., at the end of intervention phase)	1.2 score on a scale Standard Error 0.3

SECONDARY outcome

Timeframe: Early (week 1), mid (week 3), and late (week 6) training sessions within the 6-week intervention phase

Early, mid, & late training sessions will be coded for % duration of assisted (child needs trainer-provided manual assistance) versus independent navigation.

Outcome measures

Measure	Single Joystick Ride-on-car Navigation Training n=15 Participants Participants will first participate in a 6-week control phase followed by a 6-week intervention phase. During the intervention phase, they will receive the ride-on-toy navigation training program. The training will be provided by the researchers twice a week, 30-45 minutes/session for 6 weeks. Caregivers will be asked to provide 2 additional sessions/week during the intervention phase. In this study design, the participants will serve as their own controls.
Changes in Amount of Trainer Assistance Needed During Navigation Early (week 1)	73.4 %session spent in independent navigation Standard Error 4.3
Changes in Amount of Trainer Assistance Needed During Navigation Mid (week 3)	88.7 %session spent in independent navigation Standard Error 3.3
Changes in Amount of Trainer Assistance Needed During Navigation Late (week 6)	95.4 %session spent in independent navigation Standard Error 1.7

SECONDARY outcome

Timeframe: Early (week 1), mid (week 3), and late (week 6) sessions during the 6-week intervention phase

Training sessions (one early, mid, and late session each) will be video-coded for attention (i.e., % duration of attention to task-relevant targets).

Outcome measures

Measure	Single Joystick Ride-on-car Navigation Training n=15 Participants Participants will first participate in a 6-week control phase followed by a 6-week intervention phase. During the intervention phase, they will receive the ride-on-toy navigation training program. The training will be provided by the researchers twice a week, 30-45 minutes/session for 6 weeks. Caregivers will be asked to provide 2 additional sessions/week during the intervention phase. In this study design, the participants will serve as their own controls.
Changes in Child Attention During Training Sessions Early (week 1)	80.7 % duration of attention to task targets Standard Error 1.6
Changes in Child Attention During Training Sessions Mid (week 3)	83.9 % duration of attention to task targets Standard Error 1.8
Changes in Child Attention During Training Sessions Late (week 6)	83.4 % duration of attention to task targets Standard Error 1.4

SECONDARY outcome

Timeframe: Early (week 1), mid (week 3), and late (week 6) sessions during the 6-week intervention phase

Training sessions (one early, mid, and late session each) will be video-coded for child affect (i.e., smile rates, % duration of positive/interested and negative affect)

Outcome measures

Measure	Single Joystick Ride-on-car Navigation Training n=15 Participants Participants will first participate in a 6-week control phase followed by a 6-week intervention phase. During the intervention phase, they will receive the ride-on-toy navigation training program. The training will be provided by the researchers twice a week, 30-45 minutes/session for 6 weeks. Caregivers will be asked to provide 2 additional sessions/week during the intervention phase. In this study design, the participants will serve as their own controls.
Changes in Child Affect Across Training Sessions Early (week 1)	98.1 % duration in positive/interested affect Standard Error 1.1
Changes in Child Affect Across Training Sessions Mid (week 3)	99.3 % duration in positive/interested affect Standard Error 0.4
Changes in Child Affect Across Training Sessions Late (week 6)	98.9 % duration in positive/interested affect Standard Error 0.5

SECONDARY outcome

Timeframe: Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)

The path navigation test will be coded for the average duration of child-initiated, movement bouts normalized by driving time (a bout comprises 1 acceleration and 1 deceleration phase).

Outcome measures

Measure	Single Joystick Ride-on-car Navigation Training n=15 Participants Participants will first participate in a 6-week control phase followed by a 6-week intervention phase. During the intervention phase, they will receive the ride-on-toy navigation training program. The training will be provided by the researchers twice a week, 30-45 minutes/session for 6 weeks. Caregivers will be asked to provide 2 additional sessions/week during the intervention phase. In this study design, the participants will serve as their own controls.
Changes in the Duration of Movement Bouts During Navigation Across Testing Sessions Baseline	31.2 Bout Rate (bouts/min) Standard Error 3.7
Changes in the Duration of Movement Bouts During Navigation Across Testing Sessions 6-weeks (i.e., at the end of the control phase)	27.7 Bout Rate (bouts/min) Standard Error 4.2
Changes in the Duration of Movement Bouts During Navigation Across Testing Sessions 12-weeks (i.e., at the end of intervention phase)	14.8 Bout Rate (bouts/min) Standard Error 3.1

SECONDARY outcome

Timeframe: Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)

The path navigation test will be coded for the number of times the child bumps/crashes against obstacles during the navigation. We will report on the number of such bumps/crashes per minute of navigation time. Higher values of this variable indicate worse performance (poor navigational control).

Outcome measures

Measure	Single Joystick Ride-on-car Navigation Training n=15 Participants Participants will first participate in a 6-week control phase followed by a 6-week intervention phase. During the intervention phase, they will receive the ride-on-toy navigation training program. The training will be provided by the researchers twice a week, 30-45 minutes/session for 6 weeks. Caregivers will be asked to provide 2 additional sessions/week during the intervention phase. In this study design, the participants will serve as their own controls.
Changes in Rates of Obstacle Contacts Across Testing Sessions Baseline	1.4 bumps/crashes per minute Standard Error 0.3
Changes in Rates of Obstacle Contacts Across Testing Sessions 6-weeks (i.e., at the end of the control phase)	1.8 bumps/crashes per minute Standard Error 0.3
Changes in Rates of Obstacle Contacts Across Testing Sessions 12-weeks (i.e., at the end of intervention phase)	0.5 bumps/crashes per minute Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)

The path navigation test will involve children navigating through paths that are clearly demarcated using tape/chalk. We counted the number of times per minute that children went outside the demarcated path during the navigation test. Higher values of this variable indicate worse performance (poor navigational control).

Outcome measures

Measure	Single Joystick Ride-on-car Navigation Training n=15 Participants Participants will first participate in a 6-week control phase followed by a 6-week intervention phase. During the intervention phase, they will receive the ride-on-toy navigation training program. The training will be provided by the researchers twice a week, 30-45 minutes/session for 6 weeks. Caregivers will be asked to provide 2 additional sessions/week during the intervention phase. In this study design, the participants will serve as their own controls.
Changes in Rates of Path Deviations Across Testing Sessions Baseline	2.2 path deviations per minute Standard Error 0.2
Changes in Rates of Path Deviations Across Testing Sessions 6-weeks (i.e., at the end of the control phase)	2.0 path deviations per minute Standard Error 0.1
Changes in Rates of Path Deviations Across Testing Sessions 12-weeks (i.e., at the end of intervention phase)	1.2 path deviations per minute Standard Error 0.4

Adverse Events

Control Phase (Treatment-as-usual)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention Phase (Treatment-as-usual + Single Joystick Ride-on-toy Navigation Training)

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

Dr. Sudha Srinivasan

University of Connecticut Department of Kinesiology

Phone: (860)-486-6192

Email: sudha.srinivasan@uconn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place