Trial Outcomes & Findings for Effect of Virtual Reality-based Training on Balance and Walking in Youth With Autism Spectrum Disorder (NCT NCT06023563)
NCT ID: NCT06023563
Last Updated: 2025-08-12
Results Overview
High resolution pressure mat containing multiple integrated sensors is used to detect center of pressure movement of the person standing on it recorded at 100 Hz
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
5 days before the intervention, 5 days after the intervention and 4 weeks after the intervention
Results posted on
2025-08-12
Participant Flow
Participant milestones
| Measure |
Virtual Reality Active Video Gaming
The participants in this group will engage in VR active gaming using Nintendo Switch Sports under supervision via Zoom, for 6 sessions over 2 weeks.
Virtual reality active video gaming using Nintendo switch sports: Playing 2 pre-selected VR active video games from beach tennis, soccer, volleyball, badminton, bowling, and chambara for 10 minutes each with a 5 minute break in-between. Total duration 30-40 minutes.
|
Standard Balance Exercises
The participants in this group will engage in standard physical therapy exercises for balance and walking under supervision via Zoom, for 6 sessions over 2 weeks.
Standard physical therapy balance exercises: Balance exercises: Standing with feet together for 10 seconds 5 times, standing with 1 foot in front of other for 10 seconds 5 times on both sides, standing on one leg for 10 seconds 5 times on both sides, walking with one foot in front of other on a 1-meter-long line for 5 repetitions and standing on a balance board for 30 seconds for 3 repetitions. 5 minutes each of warm-up and cool down exercises. Total duration 20-30 minutes.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
|
Overall Study
COMPLETED
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Virtual Reality Active Video Gaming
n=7 Participants
The participants in this group will engage in VR active gaming using Nintendo Switch Sports under supervision via Zoom, for 6 sessions over 2 weeks.
Virtual reality active video gaming using Nintendo switch sports: Playing 2 pre-selected VR active video games from beach tennis, soccer, volleyball, badminton, bowling, and chambara for 10 minutes each with a 5 minute break in-between. Total duration 30-40 minutes.
|
Standard Balance Exercises
n=6 Participants
The participants in this group will engage in standard physical therapy exercises for balance and walking under supervision via Zoom, for 6 sessions over 2 weeks.
Standard physical therapy balance exercises: Balance exercises: Standing with feet together for 10 seconds 5 times, standing with 1 foot in front of other for 10 seconds 5 times on both sides, standing on one leg for 10 seconds 5 times on both sides, walking with one foot in front of other on a 1-meter-long line for 5 repetitions and standing on a balance board for 30 seconds for 3 repetitions. 5 minutes each of warm-up and cool down exercises. Total duration 20-30 minutes.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=7 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=13 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=7 Participants
|
4 Participants
n=6 Participants
|
9 Participants
n=13 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=13 Participants
|
|
Age, Continuous
|
17.14 years
STANDARD_DEVIATION 5.49 • n=7 Participants
|
16.0 years
STANDARD_DEVIATION 6.03 • n=6 Participants
|
17.0 years
STANDARD_DEVIATION 5.51 • n=13 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=7 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=13 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=7 Participants
|
5 Participants
n=6 Participants
|
10 Participants
n=13 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
7 participants
n=7 Participants
|
6 participants
n=6 Participants
|
13 participants
n=13 Participants
|
PRIMARY outcome
Timeframe: 5 days before the intervention, 5 days after the intervention and 4 weeks after the interventionHigh resolution pressure mat containing multiple integrated sensors is used to detect center of pressure movement of the person standing on it recorded at 100 Hz
Outcome measures
| Measure |
Virtual Reality Active Video Gaming
n=7 Participants
The participants in this group will engage in VR active gaming using Nintendo Switch Sports under supervision via Zoom, for 6 sessions over 2 weeks.
Virtual reality active video gaming using Nintendo switch sports: Playing 2 pre-selected VR active video games from beach tennis, soccer, volleyball, badminton, bowling, and chambara for 10 minutes each with a 5 minute break in-between. Total duration 30-40 minutes.
|
Standard Balance Exercises
n=6 Participants
The participants in this group will engage in standard physical therapy exercises for balance and walking under supervision via Zoom, for 6 sessions over 2 weeks.
Standard physical therapy balance exercises: Balance exercises: Standing with feet together for 10 seconds 5 times, standing with 1 foot in front of other for 10 seconds 5 times on both sides, standing on one leg for 10 seconds 5 times on both sides, walking with one foot in front of other on a 1-meter-long line for 5 repetitions and standing on a balance board for 30 seconds for 3 repetitions. 5 minutes each of warm-up and cool down exercises. Total duration 20-30 minutes.
|
|---|---|---|
|
Change in the Center of Pressure Movement (Postural Sway Velocity)
baseline
|
0.93 cm/sec
Standard Deviation 1.02
|
0.50 cm/sec
Standard Deviation 0.30
|
|
Change in the Center of Pressure Movement (Postural Sway Velocity)
post-1
|
1 cm/sec
Standard Deviation 1.1
|
0.8 cm/sec
Standard Deviation 0.69
|
|
Change in the Center of Pressure Movement (Postural Sway Velocity)
post-2
|
1.4 cm/sec
Standard Deviation 2.1
|
0.74 cm/sec
Standard Deviation 0.63
|
PRIMARY outcome
Timeframe: 5 days before the intervention, 5 days after the intervention, 4 weeks after the interventionPediatric Berg's balance Scale: 14-component battery that evaluates daily living tasks such as sitting to standing, transferring from one chair to another, and sitting and standing without support. This scale is reliable and valid clinical balance assessment tool for children and youth with motor impairments. Maximum total score is 56 points and minimum total score is 0 points. Higher score indicates better balance such that increase in total score by 3.7 points indicates minimal clinically important difference.
Outcome measures
| Measure |
Virtual Reality Active Video Gaming
n=7 Participants
The participants in this group will engage in VR active gaming using Nintendo Switch Sports under supervision via Zoom, for 6 sessions over 2 weeks.
Virtual reality active video gaming using Nintendo switch sports: Playing 2 pre-selected VR active video games from beach tennis, soccer, volleyball, badminton, bowling, and chambara for 10 minutes each with a 5 minute break in-between. Total duration 30-40 minutes.
|
Standard Balance Exercises
n=6 Participants
The participants in this group will engage in standard physical therapy exercises for balance and walking under supervision via Zoom, for 6 sessions over 2 weeks.
Standard physical therapy balance exercises: Balance exercises: Standing with feet together for 10 seconds 5 times, standing with 1 foot in front of other for 10 seconds 5 times on both sides, standing on one leg for 10 seconds 5 times on both sides, walking with one foot in front of other on a 1-meter-long line for 5 repetitions and standing on a balance board for 30 seconds for 3 repetitions. 5 minutes each of warm-up and cool down exercises. Total duration 20-30 minutes.
|
|---|---|---|
|
Change in Pediatric Berg's Balance Scale Score
baseline
|
51.86 score on a scale
Standard Deviation 2.91
|
52.00 score on a scale
Standard Deviation 2.00
|
|
Change in Pediatric Berg's Balance Scale Score
post-1
|
55.43 score on a scale
Standard Deviation 1.13
|
55 score on a scale
Standard Deviation 1.26
|
|
Change in Pediatric Berg's Balance Scale Score
post-2
|
55.14 score on a scale
Standard Deviation 1.21
|
54.67 score on a scale
Standard Deviation 1.21
|
PRIMARY outcome
Timeframe: 5 days before the intervention, 5 days after the intervention, 4 weeks after the intervention13-infra red camera system with 19-light reflecting passive markers recording at 100 Hz are used to measure the gait parameter: step length (meters).
Outcome measures
| Measure |
Virtual Reality Active Video Gaming
n=7 Participants
The participants in this group will engage in VR active gaming using Nintendo Switch Sports under supervision via Zoom, for 6 sessions over 2 weeks.
Virtual reality active video gaming using Nintendo switch sports: Playing 2 pre-selected VR active video games from beach tennis, soccer, volleyball, badminton, bowling, and chambara for 10 minutes each with a 5 minute break in-between. Total duration 30-40 minutes.
|
Standard Balance Exercises
n=6 Participants
The participants in this group will engage in standard physical therapy exercises for balance and walking under supervision via Zoom, for 6 sessions over 2 weeks.
Standard physical therapy balance exercises: Balance exercises: Standing with feet together for 10 seconds 5 times, standing with 1 foot in front of other for 10 seconds 5 times on both sides, standing on one leg for 10 seconds 5 times on both sides, walking with one foot in front of other on a 1-meter-long line for 5 repetitions and standing on a balance board for 30 seconds for 3 repetitions. 5 minutes each of warm-up and cool down exercises. Total duration 20-30 minutes.
|
|---|---|---|
|
Change in Step Length (Meters) of the Gait
Baseline
|
0.69 m
Standard Deviation 0.07
|
0.71 m
Standard Deviation 0.03
|
|
Change in Step Length (Meters) of the Gait
post-1
|
0.68 m
Standard Deviation 0.12
|
0.66 m
Standard Deviation 0.06
|
|
Change in Step Length (Meters) of the Gait
post-2
|
0.71 m
Standard Deviation 0.06
|
0.70 m
Standard Deviation 0.07
|
PRIMARY outcome
Timeframe: 5 days before the intervention, 5 days after the intervention, 4 weeks after the intervention13-infra red camera system with 19-light reflecting passive markers recording at 100 Hz are used to measure the gait parameter: step width (meters).
Outcome measures
| Measure |
Virtual Reality Active Video Gaming
n=7 Participants
The participants in this group will engage in VR active gaming using Nintendo Switch Sports under supervision via Zoom, for 6 sessions over 2 weeks.
Virtual reality active video gaming using Nintendo switch sports: Playing 2 pre-selected VR active video games from beach tennis, soccer, volleyball, badminton, bowling, and chambara for 10 minutes each with a 5 minute break in-between. Total duration 30-40 minutes.
|
Standard Balance Exercises
n=6 Participants
The participants in this group will engage in standard physical therapy exercises for balance and walking under supervision via Zoom, for 6 sessions over 2 weeks.
Standard physical therapy balance exercises: Balance exercises: Standing with feet together for 10 seconds 5 times, standing with 1 foot in front of other for 10 seconds 5 times on both sides, standing on one leg for 10 seconds 5 times on both sides, walking with one foot in front of other on a 1-meter-long line for 5 repetitions and standing on a balance board for 30 seconds for 3 repetitions. 5 minutes each of warm-up and cool down exercises. Total duration 20-30 minutes.
|
|---|---|---|
|
Change in Stride Width (Meters) of the Gait
Baseline
|
0.11 m
Standard Deviation 0.03
|
0.11 m
Standard Deviation 0.03
|
|
Change in Stride Width (Meters) of the Gait
post-1
|
0.11 m
Standard Deviation 0.03
|
0.11 m
Standard Deviation 0.02
|
|
Change in Stride Width (Meters) of the Gait
post-2
|
0.12 m
Standard Deviation 0.03
|
0.11 m
Standard Deviation 0.02
|
PRIMARY outcome
Timeframe: 5 days before the intervention, 5 days after the intervention, 4 weeks after the intervention13-infra red camera system with 19-light reflecting passive markers recording at 100 Hz are used to measure the gait parameter: stride length (meters).
Outcome measures
| Measure |
Virtual Reality Active Video Gaming
n=7 Participants
The participants in this group will engage in VR active gaming using Nintendo Switch Sports under supervision via Zoom, for 6 sessions over 2 weeks.
Virtual reality active video gaming using Nintendo switch sports: Playing 2 pre-selected VR active video games from beach tennis, soccer, volleyball, badminton, bowling, and chambara for 10 minutes each with a 5 minute break in-between. Total duration 30-40 minutes.
|
Standard Balance Exercises
n=6 Participants
The participants in this group will engage in standard physical therapy exercises for balance and walking under supervision via Zoom, for 6 sessions over 2 weeks.
Standard physical therapy balance exercises: Balance exercises: Standing with feet together for 10 seconds 5 times, standing with 1 foot in front of other for 10 seconds 5 times on both sides, standing on one leg for 10 seconds 5 times on both sides, walking with one foot in front of other on a 1-meter-long line for 5 repetitions and standing on a balance board for 30 seconds for 3 repetitions. 5 minutes each of warm-up and cool down exercises. Total duration 20-30 minutes.
|
|---|---|---|
|
Change in Stride Length (Meters) of the Gait
Baseline
|
1.33 m
Standard Deviation 0.14
|
1.37 m
Standard Deviation 0.05
|
|
Change in Stride Length (Meters) of the Gait
post-1
|
1.35 m
Standard Deviation 0.14
|
1.31 m
Standard Deviation 0.15
|
|
Change in Stride Length (Meters) of the Gait
post-2
|
1.37 m
Standard Deviation 0.14
|
1.38 m
Standard Deviation 0.14
|
PRIMARY outcome
Timeframe: 5 days before the intervention, 5 days after the intervention, 4 weeks after the intervention13-infra red camera system with 19-light reflecting passive markers recording at 100 Hz are used to measure the gait parameter: double support period (seconds).
Outcome measures
| Measure |
Virtual Reality Active Video Gaming
n=7 Participants
The participants in this group will engage in VR active gaming using Nintendo Switch Sports under supervision via Zoom, for 6 sessions over 2 weeks.
Virtual reality active video gaming using Nintendo switch sports: Playing 2 pre-selected VR active video games from beach tennis, soccer, volleyball, badminton, bowling, and chambara for 10 minutes each with a 5 minute break in-between. Total duration 30-40 minutes.
|
Standard Balance Exercises
n=6 Participants
The participants in this group will engage in standard physical therapy exercises for balance and walking under supervision via Zoom, for 6 sessions over 2 weeks.
Standard physical therapy balance exercises: Balance exercises: Standing with feet together for 10 seconds 5 times, standing with 1 foot in front of other for 10 seconds 5 times on both sides, standing on one leg for 10 seconds 5 times on both sides, walking with one foot in front of other on a 1-meter-long line for 5 repetitions and standing on a balance board for 30 seconds for 3 repetitions. 5 minutes each of warm-up and cool down exercises. Total duration 20-30 minutes.
|
|---|---|---|
|
Change in Double Support Period (Seconds) of the Gait
post-1
|
0.11 sec
Standard Deviation 0.02
|
0.17 sec
Standard Deviation 0.05
|
|
Change in Double Support Period (Seconds) of the Gait
Baseline
|
0.12 sec
Standard Deviation 0.03
|
0.15 sec
Standard Deviation 0.03
|
|
Change in Double Support Period (Seconds) of the Gait
post-2
|
0.12 sec
Standard Deviation 0.04
|
0.15 sec
Standard Deviation 0.03
|
PRIMARY outcome
Timeframe: 5 days before the intervention, 5 days after the intervention, 4 weeks after the intervention13-infra red camera system with 19-light reflecting passive markers recording at 100 Hz are used to measure the gait parameter: cadence (number of steps/minute).
Outcome measures
| Measure |
Virtual Reality Active Video Gaming
n=7 Participants
The participants in this group will engage in VR active gaming using Nintendo Switch Sports under supervision via Zoom, for 6 sessions over 2 weeks.
Virtual reality active video gaming using Nintendo switch sports: Playing 2 pre-selected VR active video games from beach tennis, soccer, volleyball, badminton, bowling, and chambara for 10 minutes each with a 5 minute break in-between. Total duration 30-40 minutes.
|
Standard Balance Exercises
n=6 Participants
The participants in this group will engage in standard physical therapy exercises for balance and walking under supervision via Zoom, for 6 sessions over 2 weeks.
Standard physical therapy balance exercises: Balance exercises: Standing with feet together for 10 seconds 5 times, standing with 1 foot in front of other for 10 seconds 5 times on both sides, standing on one leg for 10 seconds 5 times on both sides, walking with one foot in front of other on a 1-meter-long line for 5 repetitions and standing on a balance board for 30 seconds for 3 repetitions. 5 minutes each of warm-up and cool down exercises. Total duration 20-30 minutes.
|
|---|---|---|
|
Change in the Cadence (Steps/Minute) of the Gait
baseline
|
111.96 steps/min
Standard Deviation 9.89
|
110.31 steps/min
Standard Deviation 4.85
|
|
Change in the Cadence (Steps/Minute) of the Gait
post-1
|
114.70 steps/min
Standard Deviation 8.98
|
115.80 steps/min
Standard Deviation 14.97
|
|
Change in the Cadence (Steps/Minute) of the Gait
post-2
|
113.76 steps/min
Standard Deviation 6.52
|
113.71 steps/min
Standard Deviation 3.51
|
PRIMARY outcome
Timeframe: 5 days before the intervention, 5 days after the intervention, 4 weeks after the intervention13-infra red camera system with 19-light reflecting passive markers recording at 100 Hz are used to measure the gait parameter: gait velocity (meters/second).
Outcome measures
| Measure |
Virtual Reality Active Video Gaming
n=7 Participants
The participants in this group will engage in VR active gaming using Nintendo Switch Sports under supervision via Zoom, for 6 sessions over 2 weeks.
Virtual reality active video gaming using Nintendo switch sports: Playing 2 pre-selected VR active video games from beach tennis, soccer, volleyball, badminton, bowling, and chambara for 10 minutes each with a 5 minute break in-between. Total duration 30-40 minutes.
|
Standard Balance Exercises
n=6 Participants
The participants in this group will engage in standard physical therapy exercises for balance and walking under supervision via Zoom, for 6 sessions over 2 weeks.
Standard physical therapy balance exercises: Balance exercises: Standing with feet together for 10 seconds 5 times, standing with 1 foot in front of other for 10 seconds 5 times on both sides, standing on one leg for 10 seconds 5 times on both sides, walking with one foot in front of other on a 1-meter-long line for 5 repetitions and standing on a balance board for 30 seconds for 3 repetitions. 5 minutes each of warm-up and cool down exercises. Total duration 20-30 minutes.
|
|---|---|---|
|
Change in Gait Velocity (Meters/Second)
baseline
|
1.27 m/sec
Standard Deviation 0.21
|
1.25 m/sec
Standard Deviation 0.10
|
|
Change in Gait Velocity (Meters/Second)
post-1
|
1.30 m/sec
Standard Deviation 0.20
|
1.20 m/sec
Standard Deviation 0.12
|
|
Change in Gait Velocity (Meters/Second)
post-2
|
1.30 m/sec
Standard Deviation 0.18
|
1.29 m/sec
Standard Deviation 0.09
|
Adverse Events
Virtual Reality Active Video Gaming
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Balance Exercises
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. Georgia Frey, Faculty, Department of Kinesiology
Indiana University
Phone: (812) 855-1262
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place