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

NCT03765398 | Completed Results

• 2 other identifiers: 2018-12572P30AG022849-11
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Older adults often display gait instability, impaired balance control and cognitive decline that lead to falls and fall risks. Approximately 60% of the elderly people with cognitive deficits experience a detrimental fall each year. Such motor and cognitive impairments further decreases physical activity levels in this population leading to restricted community integration, social behavior, depression and long-term disability. With the help of computer technology, studies have employed virtual-reality based interventions to address the above-mentioned concerns including sensori-motor, balance control and cognitive impairments. Previous studies have demonstrated promising results on improving the behavioral outcomes, and have identified such interventions have the potential to improve the underlying neurophysiological outcomes as well. While VR based training studies have demonstrated remarkable improvement in the balance control and gait parameters, physical activity levels and fall risk reduction, the gains on cognitive function is less pronounced. There is little evidence that VR-based training can explicitly address the higher executive cognitive domains associated with balance control and falls. Further, the effect of VR-based training on balance control and cognitive function is unknown among the older adults with mild cognitive impairment. Therefore, to address the cognitive domains explicitly, the current study aims to test the applicability of Wii-Fit Nintendo along with an additional cognitive load delivered via VR-based cognitive-motor training paradigm (VR-CogMoBal) in older adults with mild cognitive impairment. Lastly, the study also aims to identify the effect of such training on the underlying behavioral and neural outcomes. The behavioral outcomes will be assessed via performance on dual-tasking and clinical measures in the laboratory. The underlying neural outcomes will be assessed via fMRI outcomes. In order to determine the generalizing training effect at community level, a pilot sub-study to determine the physical activity levels post 4 weeks of training will also be conducted.

Conditions

Mild Cognitive Impairment

Keywords

Dual-task training; Virtual-reality exergaming; Cognitive-motor-balance training; Mild cognitive impairment; Older adults

Outcome Measures

Primary Outcomes (8)

• Change in Maximum Excursion

  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.

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

• Change in 4 Meter Walk Test

  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.

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

• Change of Accuracy in Letter Number Sequencing

  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.

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

• Change in Working Memory

  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.

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

• Change in Episodic Memory

  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.

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

• Change in Accuracy of Flanker Inhibitory Control and Attention Test

  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.

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

• Change in Cognitive Flexibility and Attention

  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.

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

• Change in Processing Speed

  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.

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

Secondary Outcomes (16)

• Change in Movement Velocity

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

• Changes in End Point Excursion

  Baseline (Week 0) and post-training (Week 5)

• Change in Directional Control

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

• Change in Postural Stability During Reactive Balance Control (Single and Dual-task)

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

• Change in Accuracy of Auditory Stroop

  Baseline (Week 0) and post-training (Week 5)

Study Arms (1)

VR Cognitive-motor-balance training

EXPERIMENTAL

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.

Behavioral: VR Cognitive-motor-balance training

Interventions

VR Cognitive-motor-balance training BEHAVIORAL

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.

Also known as: VR-CogMoBal, Dual-task training

VR Cognitive-motor-balance training

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• MOCA less than 26 out of 30
• Bone density with a T-score ≥ -2.5
• Can understand and communicate in English
• Ability to stand for at least 5 minutes without an assistive device (length of a Wii Fit game)

You may not qualify if:

• any acute or chronic neurological (Stroke, Parkinson's disease, Alzheimer's disease), cardiopulmonary, musculoskeletal, or systemic diagnosis
• recent major surgery (\< 6 months) or hospitalization (\< 3 months)
• Use of any sedative drugs
• HR \> 85% of age-predicted maximal heart rate (HRmax) (HRmax = 220 - age)
• systolic blood pressure (SBP) \> 165 mmHg and/or diastolic blood pressure (DBP) \> 110 mmHg during resting), and/or oxygen saturation (measured by pulse oximeter) during resting \< 90%
• Specific to MRI: Self-reported presence of pacemaker, metal implants, and/or Claustrophobia

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Tanvi Bhatt
• Organization: University of Illinois at Chicago

tbhatt6@uic.edu

3123554443

Study Officials

• Tanvi S Bhatt, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 5, 2018
• Study Start: November 28, 2018
• Primary Completion: September 5, 2022
• Study Completion: March 15, 2023
• Last Updated: July 3, 2025
• Results First Posted: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)