Trial Outcomes & Findings for VR-CogMoBal Training for Reducing Falls Among Older Adults With Mild Cognitive Impairment (NCT NCT03765398)

Results Overview

It is the actual magnitude of a self-initiated movement (i.e., how far did he/she actually reach a target) without taking a step or losing balance measured in percentage under single and dual-task conditions. Higher values indicate better performance.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

27 participants

Primary outcome timeframe

Baseline (Week 0) and Immediate Post-training (Week 5)

Results posted on

2025-07-03

Participant Flow

Participant milestones

Participant milestones
Measure	VR Cognitive-motor-balance Training Virtual reality based cognitive-motor balance (VR-CogMoBal) training will be delivered using the commercially available Wii-Fit Nintendo in conjunction with cognitive training. All participants will undergo 12 sessions of training in a tapering manner for four weeks with 90 minutes of training per session, i.e., 5 sessions for the first week, 3 sessions for the second week, and 2 sessions for the third and fourth week. Each session will be divided into 3 sub-sessions, where each sub-session will consist of playing 4 games in conjunction with cognitive task. All the games will be performed using a Wii-Fit balance board in front of a TV screen. VR Cognitive-motor-balance training: The participant will play four of the six balance board games Table tilt, Tightrope, Soccer, Balance bubble, Light Run and Basic Step (each game is max 1.5 minutes). Each game will be superimposed with any 3 of the 6 cognitive tasks (word list generation consisting of verbal fluency (VF) and category fluency (CF), digit recall (DR), analogies (AN), mental arithmetic (MA), repeated letter (RL). The cognitive tasks will be randomized making sure that all the cognitive tasks are played with all the games. The cognitive and balance board game scores will be noted on the scoring sheet for each session. A total 10 minutes rest interval between every sub-session will be mandatorily provided.
Baseline Measurements STARTED	18
Baseline Measurements COMPLETED	14
Baseline Measurements NOT COMPLETED	4
Intervention STARTED	14
Intervention COMPLETED	10
Intervention NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

VR-CogMoBal Training for Reducing Falls Among Older Adults With Mild Cognitive Impairment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VR Cognitive-motor-balance Training n=18 Participants Virtual reality based cognitive-motor balance (VR-CogMoBal) training will be delivered using the commercially available Wii-Fit Nintendo in conjunction with cognitive training. All participants will undergo 12 sessions of training in a tapering manner for four weeks with 90 minutes of training per session, i.e., 5 sessions for the first week, 3 sessions for the second week, and 2 sessions for the third and fourth week. Each session will be divided into 3 sub-sessions, where each sub-session will consist of playing 4 games in conjunction with cognitive task. All the games will be performed using a Wii-Fit balance board in front of a TV screen. VR Cognitive-motor-balance training: The participant will play four of the six balance board games Table tilt, Tightrope, Soccer, Balance bubble, Light Run and Basic Step (each game is max 1.5 minutes). Each game will be superimposed with any 3 of the 6 cognitive tasks (word list generation consisting of verbal fluency (VF) and category fluency (CF), digit recall (DR), analogies (AN), mental arithmetic (MA), repeated letter (RL). The cognitive tasks will be randomized making sure that all the cognitive tasks are played with all the games. The cognitive and balance board game scores will be noted on the scoring sheet for each session. A total 10 minutes rest interval between every sub-session will be mandatorily provided.
Age, Continuous	63.2 years STANDARD_DEVIATION 5.25 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	18 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Montreal Cognitive Assessment	22.6 units on a scale of 0-30 STANDARD_DEVIATION 3.15 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Week 0) and Immediate Post-training (Week 5)

It is the actual magnitude of a self-initiated movement (i.e., how far did he/she actually reach a target) without taking a step or losing balance measured in percentage under single and dual-task conditions. Higher values indicate better performance.

Outcome measures

Outcome measures
Measure	VR Cognitive-motor-balance Training n=10 Participants Virtual reality based cognitive-motor balance (VR-CogMoBal) training will be delivered using the commercially available Wii-Fit Nintendo in conjunction with cognitive training. All participants will undergo 12 sessions of training in a tapering manner for four weeks with 90 minutes of training per session, i.e., 5 sessions for the first week, 3 sessions for the second week, and 2 sessions for the third and fourth week. Each session will be divided into 3 sub-sessions, where each sub-session will consist of playing 4 games in conjunction with cognitive task. All the games will be performed using a Wii-Fit balance board in front of a TV screen. VR Cognitive-motor-balance training: The participant will play four of the six balance board games Table tilt, Tightrope, Soccer, Balance bubble, Light Run and Basic Step (each game is max 1.5 minutes). Each game will be superimposed with any 3 of the 6 cognitive tasks (word list generation consisting of verbal fluency (VF) and category fluency (CF), digit recall (DR), analogies (AN), mental arithmetic (MA), repeated letter (RL). The cognitive tasks will be randomized making sure that all the cognitive tasks are played with all the games. The cognitive and balance board game scores will be noted on the scoring sheet for each session. A total 10 minutes rest interval between every sub-session will be mandatorily provided.
Change in Maximum Excursion Maximum excursion in forward Direction, Pre-Training	80.9 percentage of center of pressure motion Standard Deviation 13.8
Change in Maximum Excursion Maximum excursion in Forward Direction, Post-Training	86.5 percentage of center of pressure motion Standard Deviation 15
Change in Maximum Excursion Maximum excursion in Backward Direction, Pre-Training	66.8 percentage of center of pressure motion Standard Deviation 17.7
Change in Maximum Excursion Maximum excursion in Backward Direction, Post-Training	80.9 percentage of center of pressure motion Standard Deviation 11.8
Change in Maximum Excursion Maximum excursion in Left Direction, Pre-Training	80.7 percentage of center of pressure motion Standard Deviation 11.0
Change in Maximum Excursion Maximum excursion in Left Direction, Post-Training	87.1 percentage of center of pressure motion Standard Deviation 5.3
Change in Maximum Excursion Maximum excursion in Right Direction, Pre-Training	76.4 percentage of center of pressure motion Standard Deviation 11.2
Change in Maximum Excursion Maximum excursion in Right Direction, Post-Training	87.3 percentage of center of pressure motion Standard Deviation 6.9
Change in Maximum Excursion Maximum excursion in Forward Direction while performing auditory clock test, Pre-Training	72.0 percentage of center of pressure motion Standard Deviation 23.6
Change in Maximum Excursion Maximum excursion in Forward Direction while performing auditory clock test, Post-Training	84.2 percentage of center of pressure motion Standard Deviation 17.4
Change in Maximum Excursion Maximum excursion in Backward Direction while performing auditory clock test, Pre-Training	61.9 percentage of center of pressure motion Standard Deviation 15.1
Change in Maximum Excursion Maximum excursion in Backward Direction while performing auditory clock test, Post-Training	66.2 percentage of center of pressure motion Standard Deviation 21.1
Change in Maximum Excursion Maximum excursion in Left Direction while performing auditory clock test, Pre-Training	71.8 percentage of center of pressure motion Standard Deviation 14.2
Change in Maximum Excursion Maximum excursion in Left Direction while performing auditory clock test, Post-Training	84.7 percentage of center of pressure motion Standard Deviation 6.8
Change in Maximum Excursion Maximum excursion in Right Direction while performing auditory clock test, Pre-Training	72.9 percentage of center of pressure motion Standard Deviation 14.2
Change in Maximum Excursion Maximum excursion in Right Direction while performing auditory clock test, Post-Training	86.1 percentage of center of pressure motion Standard Deviation 9.2
Change in Maximum Excursion Maximum excursion in Forward Direction while performing letter number sequencing, Pre-Training	69.6 percentage of center of pressure motion Standard Deviation 20.5
Change in Maximum Excursion Maximum excursion in Forward Direction while performing letter number sequencing, Post-Training	80.7 percentage of center of pressure motion Standard Deviation 16.9
Change in Maximum Excursion Maximum excursion in Backward Direction while performing letter number sequencing, Pre-Training	58.1 percentage of center of pressure motion Standard Deviation 21.4
Change in Maximum Excursion Maximum excursion in Backward Direction while performing letter number sequencing, Post-Training	71.2 percentage of center of pressure motion Standard Deviation 16.3
Change in Maximum Excursion Maximum excursion in Left Direction while performing letter number sequencing, Pre-Training	68.2 percentage of center of pressure motion Standard Deviation 18.0
Change in Maximum Excursion Maximum excursion in Left Direction while performing letter number sequencing, Post-Training	84.8 percentage of center of pressure motion Standard Deviation 5.8
Change in Maximum Excursion Maximum excursion in Right Direction while performing letter number sequencing, Pre-Training	72.9 percentage of center of pressure motion Standard Deviation 14.0
Change in Maximum Excursion Maximum excursion in Right Direction while performing letter number sequencing, Post-Training	80.3 percentage of center of pressure motion Standard Deviation 10.2

PRIMARY outcome

Timeframe: Baseline (Week 0) and Immediate Post-training (Week 5)

The total time taken to complete the 4 meters will be noted. Speed will then be determined by using the formula distance (4 meters) covered by time taken to complete the test. Higher speed indicate better performance.

Outcome measures

Outcome measures
Measure	VR Cognitive-motor-balance Training n=10 Participants Virtual reality based cognitive-motor balance (VR-CogMoBal) training will be delivered using the commercially available Wii-Fit Nintendo in conjunction with cognitive training. All participants will undergo 12 sessions of training in a tapering manner for four weeks with 90 minutes of training per session, i.e., 5 sessions for the first week, 3 sessions for the second week, and 2 sessions for the third and fourth week. Each session will be divided into 3 sub-sessions, where each sub-session will consist of playing 4 games in conjunction with cognitive task. All the games will be performed using a Wii-Fit balance board in front of a TV screen. VR Cognitive-motor-balance training: The participant will play four of the six balance board games Table tilt, Tightrope, Soccer, Balance bubble, Light Run and Basic Step (each game is max 1.5 minutes). Each game will be superimposed with any 3 of the 6 cognitive tasks (word list generation consisting of verbal fluency (VF) and category fluency (CF), digit recall (DR), analogies (AN), mental arithmetic (MA), repeated letter (RL). The cognitive tasks will be randomized making sure that all the cognitive tasks are played with all the games. The cognitive and balance board game scores will be noted on the scoring sheet for each session. A total 10 minutes rest interval between every sub-session will be mandatorily provided.
Change in 4 Meter Walk Test Pre-Training	0.95 m/s Standard Deviation 0.08
Change in 4 Meter Walk Test Post-Training	1.08 m/s Standard Deviation 0.14

PRIMARY outcome

Timeframe: Baseline (Week 0) and Immediate Post-training (Week 5)

This is an oral trail making test which includes listing alternate letter and number from the cue given in sequence. This test will be performed under single and dual-task conditions. For the auditory clock test, the participant is provided with cues that include different times of the day (e.g., 3.15) and the participant has to answer a yes if the hour and the minute hand of the clock are on the same side and no if the hour and minute hand are on opposite side of the clock. For the letter number sequencing test, the participant will be provided sets of letters and numbers (e.g.., A1) and will be asked to list in sequence the consecutive letter and numbers (e.g., B2, C3, D4, E5) until the next cue is provided. The performance will be measured in terms of accuracy (number of correct responses out of the total responses) for both the tests. Higher accuracy i.e., higher percentage indicates better performance.

Outcome measures

Outcome measures
Measure	VR Cognitive-motor-balance Training n=10 Participants Virtual reality based cognitive-motor balance (VR-CogMoBal) training will be delivered using the commercially available Wii-Fit Nintendo in conjunction with cognitive training. All participants will undergo 12 sessions of training in a tapering manner for four weeks with 90 minutes of training per session, i.e., 5 sessions for the first week, 3 sessions for the second week, and 2 sessions for the third and fourth week. Each session will be divided into 3 sub-sessions, where each sub-session will consist of playing 4 games in conjunction with cognitive task. All the games will be performed using a Wii-Fit balance board in front of a TV screen. VR Cognitive-motor-balance training: The participant will play four of the six balance board games Table tilt, Tightrope, Soccer, Balance bubble, Light Run and Basic Step (each game is max 1.5 minutes). Each game will be superimposed with any 3 of the 6 cognitive tasks (word list generation consisting of verbal fluency (VF) and category fluency (CF), digit recall (DR), analogies (AN), mental arithmetic (MA), repeated letter (RL). The cognitive tasks will be randomized making sure that all the cognitive tasks are played with all the games. The cognitive and balance board game scores will be noted on the scoring sheet for each session. A total 10 minutes rest interval between every sub-session will be mandatorily provided.
Change of Accuracy in Letter Number Sequencing Single Task, Pre-Training	65 percentage of total responses Standard Deviation 27
Change of Accuracy in Letter Number Sequencing Single Task, Post-Training	77 percentage of total responses Standard Deviation 19
Change of Accuracy in Letter Number Sequencing Dual Task during forward leaning, Pre-Training	69 percentage of total responses Standard Deviation 23
Change of Accuracy in Letter Number Sequencing Dual Task during forward leaning, Post-Training	63 percentage of total responses Standard Deviation 33
Change of Accuracy in Letter Number Sequencing Dual Task during backward leaning, Pre-Training	40 percentage of total responses Standard Deviation 38
Change of Accuracy in Letter Number Sequencing Dual Task during backward leaning, Post-Training	51 percentage of total responses Standard Deviation 30
Change of Accuracy in Letter Number Sequencing Dual Task during left leaning, Pre-Training	51 percentage of total responses Standard Deviation 30
Change of Accuracy in Letter Number Sequencing Dual Task during left leaning, Post-Training	57 percentage of total responses Standard Deviation 31
Change of Accuracy in Letter Number Sequencing Dual Task during right leaning, Pre-Training	50 percentage of total responses Standard Deviation 31
Change of Accuracy in Letter Number Sequencing Dual Task during right leaning, Post-Training	64 percentage of total responses Standard Deviation 30

PRIMARY outcome

Timeframe: Baseline (Week 0) and Immediate Post-training (Week 5)

List Sorting Memory test to evaluate working memory. This test requires the participant to recall and sequentially list the visually and orally presented stimuli. The accuracy of the participants response is computer generated. Higher value indicate better performance. The total possible responses are 28.

Outcome measures

Outcome measures
Measure	VR Cognitive-motor-balance Training n=10 Participants Virtual reality based cognitive-motor balance (VR-CogMoBal) training will be delivered using the commercially available Wii-Fit Nintendo in conjunction with cognitive training. All participants will undergo 12 sessions of training in a tapering manner for four weeks with 90 minutes of training per session, i.e., 5 sessions for the first week, 3 sessions for the second week, and 2 sessions for the third and fourth week. Each session will be divided into 3 sub-sessions, where each sub-session will consist of playing 4 games in conjunction with cognitive task. All the games will be performed using a Wii-Fit balance board in front of a TV screen. VR Cognitive-motor-balance training: The participant will play four of the six balance board games Table tilt, Tightrope, Soccer, Balance bubble, Light Run and Basic Step (each game is max 1.5 minutes). Each game will be superimposed with any 3 of the 6 cognitive tasks (word list generation consisting of verbal fluency (VF) and category fluency (CF), digit recall (DR), analogies (AN), mental arithmetic (MA), repeated letter (RL). The cognitive tasks will be randomized making sure that all the cognitive tasks are played with all the games. The cognitive and balance board game scores will be noted on the scoring sheet for each session. A total 10 minutes rest interval between every sub-session will be mandatorily provided.
Change in Working Memory Pre-Training	12.1 correct responses Standard Deviation 1.0
Change in Working Memory Post-Training	13.6 correct responses Standard Deviation 2.8

PRIMARY outcome

Timeframe: Baseline (Week 0) and Immediate Post-training (Week 5)

Picture sequence memory test will assess episodic memory of the individual. The number of adjacent pairs of pictures placed correctly will score a point. The scores are computer generated. Higher value indicate better performance.

Outcome measures

Outcome measures
Measure	VR Cognitive-motor-balance Training n=10 Participants Virtual reality based cognitive-motor balance (VR-CogMoBal) training will be delivered using the commercially available Wii-Fit Nintendo in conjunction with cognitive training. All participants will undergo 12 sessions of training in a tapering manner for four weeks with 90 minutes of training per session, i.e., 5 sessions for the first week, 3 sessions for the second week, and 2 sessions for the third and fourth week. Each session will be divided into 3 sub-sessions, where each sub-session will consist of playing 4 games in conjunction with cognitive task. All the games will be performed using a Wii-Fit balance board in front of a TV screen. VR Cognitive-motor-balance training: The participant will play four of the six balance board games Table tilt, Tightrope, Soccer, Balance bubble, Light Run and Basic Step (each game is max 1.5 minutes). Each game will be superimposed with any 3 of the 6 cognitive tasks (word list generation consisting of verbal fluency (VF) and category fluency (CF), digit recall (DR), analogies (AN), mental arithmetic (MA), repeated letter (RL). The cognitive tasks will be randomized making sure that all the cognitive tasks are played with all the games. The cognitive and balance board game scores will be noted on the scoring sheet for each session. A total 10 minutes rest interval between every sub-session will be mandatorily provided.
Change in Episodic Memory Pre-Training	17.3 accuracy (%) Standard Deviation 9.6
Change in Episodic Memory Post-Training	27.4 accuracy (%) Standard Deviation 9.1

PRIMARY outcome

Timeframe: Baseline (Week 0) and Immediate Post-training (Week 5)

Flanker inhibitory control and attention test is used to evaluate the participants ability to inhibit the attention to the stimulus flanking it and focus on a particular stimulus. Accuracy of the responses are recorded and the scores are computer generated. Higher value indicate better performance.

Outcome measures

Outcome measures
Measure	VR Cognitive-motor-balance Training n=10 Participants Virtual reality based cognitive-motor balance (VR-CogMoBal) training will be delivered using the commercially available Wii-Fit Nintendo in conjunction with cognitive training. All participants will undergo 12 sessions of training in a tapering manner for four weeks with 90 minutes of training per session, i.e., 5 sessions for the first week, 3 sessions for the second week, and 2 sessions for the third and fourth week. Each session will be divided into 3 sub-sessions, where each sub-session will consist of playing 4 games in conjunction with cognitive task. All the games will be performed using a Wii-Fit balance board in front of a TV screen. VR Cognitive-motor-balance training: The participant will play four of the six balance board games Table tilt, Tightrope, Soccer, Balance bubble, Light Run and Basic Step (each game is max 1.5 minutes). Each game will be superimposed with any 3 of the 6 cognitive tasks (word list generation consisting of verbal fluency (VF) and category fluency (CF), digit recall (DR), analogies (AN), mental arithmetic (MA), repeated letter (RL). The cognitive tasks will be randomized making sure that all the cognitive tasks are played with all the games. The cognitive and balance board game scores will be noted on the scoring sheet for each session. A total 10 minutes rest interval between every sub-session will be mandatorily provided.
Change in Accuracy of Flanker Inhibitory Control and Attention Test Pre-Training	39.6 % accurate Standard Deviation 0.97
Change in Accuracy of Flanker Inhibitory Control and Attention Test Post-Training	40 % accurate Standard Deviation 0.0

PRIMARY outcome

Timeframe: Baseline (Week 0) and Immediate Post-training (Week 5)

Dimensional Change card sort assesses cognitive flexibility and attention. Participants are asked to match a series of bivalent pictures either by colors or shapes accordingly. Responses are computer recorded and accuracy scores are computer generated. Higher value indicate better performance.

Outcome measures

Outcome measures
Measure	VR Cognitive-motor-balance Training n=10 Participants Virtual reality based cognitive-motor balance (VR-CogMoBal) training will be delivered using the commercially available Wii-Fit Nintendo in conjunction with cognitive training. All participants will undergo 12 sessions of training in a tapering manner for four weeks with 90 minutes of training per session, i.e., 5 sessions for the first week, 3 sessions for the second week, and 2 sessions for the third and fourth week. Each session will be divided into 3 sub-sessions, where each sub-session will consist of playing 4 games in conjunction with cognitive task. All the games will be performed using a Wii-Fit balance board in front of a TV screen. VR Cognitive-motor-balance training: The participant will play four of the six balance board games Table tilt, Tightrope, Soccer, Balance bubble, Light Run and Basic Step (each game is max 1.5 minutes). Each game will be superimposed with any 3 of the 6 cognitive tasks (word list generation consisting of verbal fluency (VF) and category fluency (CF), digit recall (DR), analogies (AN), mental arithmetic (MA), repeated letter (RL). The cognitive tasks will be randomized making sure that all the cognitive tasks are played with all the games. The cognitive and balance board game scores will be noted on the scoring sheet for each session. A total 10 minutes rest interval between every sub-session will be mandatorily provided.
Change in Cognitive Flexibility and Attention Pre-Training	34.3 % accurate Standard Deviation 5.4
Change in Cognitive Flexibility and Attention Post-Training	38.5 % accurate Standard Deviation 3.7

PRIMARY outcome

Timeframe: Baseline (Week 0) and Immediate Post-training (Week 5)

Pattern comparison processing speed test is used to evaluate the processing speed. The participants are expected to respond whether the two pictures side-by side are same or not the same. Accuracy will be recorded by the number of correct responses out of the total questions in 90 seconds. Scores are computer generated. Higher value indicate better performance.