Mild Cognitive ImpairmentNCT03765398
VR-CogMoBal Training for Reducing Falls Among Older Adults With Mild Cognitive Impairment
A study testing VR Cognitive-motor-balance training in people with Mild Cognitive Impairment, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- VR Cognitive-motor-balance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2018to 15 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
Official title: Virtual-reality Based Cognitive-motor-balance (VR-CogMoBal) Training: Examining Behavioral and Neuromarkers for Fall-risk Reduction in Older Adults With Mild Cognitive Impairment
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.
Read the detailed description
Older adults suffer from mild cognitive impairments with a prevalence rate of 3% to 22% and an incidence rate of 1% to 6% per year in the United States. Along with age associated locomotor-balance impairments, such cognitive decline among the elderly is known to increase the risk of falls, reduced physical activity and community integration, thus contributing to long-term disability. Daily living activities comprises of several concurrent motor and cognitive performances (dual-tasking) such as shopping in a supermarket, that requires higher executive cognitive functions and intact locomotor-balance control abilities. Falls during dual-tasking occur mostly due to the interference caused, i.e. during dual-task performances, either one or both task (motor or cognitive) performance is deteriorated that is known as cognitive-motor interference. Given that dual-task performances decline due to age-associated factors, daily living activities are highly challenging and difficult to perform for older adults with mild cognitive impairment. Although there are several conventional methods that incorporate locomotor-balance training, the nature of such interventions does not result in pronounced cognitive gains. Additionally, these interventions lack multi-sensory feedback, and due to the monotonous and repeated task practice of exercises characteristic, individuals do not seem to adhere to therapy leading to less compliance and decreased motivation to exercise training. In order to overcome such barriers, alternate form of therapy with the help of Virtual-reality devices, especially off the shelf commercially available exercise platforms emerged for training purposes. Although there is evidence that VR based training improves locomotor-balance control and is known to implicitly address cognitive functions, there is no knowledge that such VR based training can explicitly address higher executive cognitive functions. Therefore, based on preliminary studies tested the efficacy of cognitive training along with exergaming delivered via the commercially available off the shelf device- Wii-fit Nintendo and demonstrated promising results in improving balance control and cognitive function among the individuals with Chronic Stroke. The study resulted in decreased cognitive-motor interference during dual-task performance thereby exhibiting an improved performance on both cognitive and balance control function. Currently, there is lack of knowledge in determining specific interventions for improving dual-task performances among the older adults with MCI. Given that mild cognitive impaired older adults suffer from both motor and cognitive impairments, there is a need for testing the feasibility of a similar intervention among them and determine the change in the underlying neural biomarkers.
Aim 1: The study is designed to test the feasibility (tolerability, compliance and effectiveness) of VR-CogMoBal training to improve physical function and reduce fall-risk in community-dwelling older adults with mild cognitive deficits by lowering cognitive-motor interference and dual task costs.
Hypothesis: Participants will tolerate the training paradigm and will demonstrate significant improvements in balance, gait, cardiovascular and cognitive performance under dual-task conditions.
Aim 2: To examine if the (VR-CogMoBal) will lead to higher cognitive function post-intervention.
Hypothesis: Post-training compared to pre-training participants will show significantly greater global cognitive function, executive and working memory and decreased cognitive-motor load.
Aim 3: To examine effect of VR-CogMoBal Training on changes in structural and functional connectivity within the cognitive-motor areas in the brain.
Hypothesis: Post-training compared to pre-training, participants will show increased structural and functional connectivity at rest in the default mode network (memory consolidation, self-referential memory), fronto-parietal and supplementary motor areas (motor planning and execution, attention).
Pilot Sub-study aim:
The study aims to monitor the change in the number of steps taken a day before undergoing VR training and 4 weeks post-training.
- Conditions
- Mild Cognitive Impairment
- Being tested
- VR Cognitive-motor-balance training
- Keywords
- Dual-task training, Virtual-reality exergaming, Cognitive-motor-balance training, Mild cognitive impairment, Older adults
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR Cognitive-motor-balance trainingBehavioural
Also called VR-CogMoBal, Dual-task 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: VR Cognitive-motor-balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Week 0) and Immediate Post-training (Week 5)
Secondary outcomes (16)
Change in Movement Velocity
It is the average speed of center of gravity movement during intentional movement measured in degrees per second under single and dual-task conditions. Higher values indicate better performance.
Measured: Baseline (Week 0) and Immediate post-training (Week 5)
Changes in End Point Excursion
It is the magnitude of a self-initiated movement (i.e., how far he/she wills to reach a target) without taking a step or losing balance measured in percentage under single and dual-task conditions. Higher values indicate better performance.
Measured: Baseline (Week 0) and post-training (Week 5)
Change in Directional Control
It is the quality of a self-initiated movement (i.e., amount of movement actually exhibited towards the target to the amount of extraneous movement away from the target) measured in percentage under single and dual-task conditions. Higher values indicate better performance.
Measured: Baseline (Week 0) and Post-training (Week 5)
Change in Postural Stability During Reactive Balance Control (Single and Dual-task)
Reactive balance control will be examined via the stance perturbation test under single and dual-task conditions (simultaneous performance of Letter number sequencing task or auditory stroop task). Postural stability can be defined as simultaneous control of center of mass (COM) position and velocity during slip-like or trip like perturbation relative to the rear edge of base of support (rear heel). The position is normalized with the individual's foot length, and velocity by square root of gravitational acceleration and individual's body height. Larger values indicate greater stability.
Measured: Baseline (Week 0) and Post-training (Week 5)
Change in Accuracy of Auditory Stroop
This test involves responding to the pitch (high or low) of the words "High" or "Low". This test will be performed under single and dual-task conditions.
Accuracy (number of correct responses out of the total responses) of Auditory stroop will be calculated. Higher accuracy indicates better performance. Higher values indicate better performance.
Measured: Baseline (Week 0) and post-training (Week 5)
Change in Dual-task Cost
Dual-task motor and cognitive cost will be calculated using the formula- [(Dual-task performance- Single Task performance)/Single task performance*100]. This will be calculated for dual-task performance during intentional postural sway, reactive balance control and gait conditions. Lower cost indicates better performance.
Measured: Baseline (Week 0) and Post-training (Week 5)
Change in Gait Parameters
Spatial and temporal gait parameters like step length, cadence and stride length will be determined during single and dual-task walking performance via the GaitRite mat. Higher values for step length and stride length, and lower cadence indicates better performance.
Measured: Baseline (Week 0) and post-training (Week 5)
Change in Interference in the Reaction Time
Interference in the reaction time via visual stroop task where the individual is expected to respond to the color in which the word is printed and not read the word. Performance will be identified via time taken to complete the test. Lower time indicates better performance.
Measured: Baseline (Week 0) and Post-training (Week 5)
Change in Language Fluency
Language fluency via verbal and category task will be administered. Performance will be identified via the total number of appropriate words responded on each of the task. Higher values indicate better performance.
Measured: Baseline (Week 0) and Post-training (Week 5)
Change in Interference in Reaction Time
The individual is asked to hit a key on the number keypad when a cue appears on the screen. Performance will be identified with time taken to hit the key after the individual sees the cue in seconds. Lower time indicates better performance.
Measured: Baseline (Week 0) and Post-training (Week 5)
Change in Paired Associative Learning
Paired associated learning via grid task will be administered. Accuracy (number of correct responses out of the total responses) will be represented in percentage. Higher value indicates better performance.
Measured: Baseline (Week 0) and Post-training (Week 5)
Change in Spatial 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 participant's response is computer generated. Higher value indicates better performance. The minimum score is 0% and maximum score is 100%
Measured: Baseline (Week 0) and Post-training (Week 5)
Change in Reaction Time
The individual is asked to hit a key on the number keypad when a cue appears on the screen. Performance will be identified with time taken to hit the key after the individual sees the cue in seconds. Lower time indicates better performance.
Measured: Baseline (Week 0) and Post-training (Week 5)
Changes in Fractional Anisotropy
Fractional anisotropy (FA) is a scalar measure derived from diffusion tensor imaging (DTI) that quantifies the directional dependence of water molecule diffusion in biological tissues. Ranging from 0 (completely isotropic diffusion, as in cerebrospinal fluid) to 1 (fully anisotropic diffusion, seen in highly organized white matter tracts), FA reflects microstructural properties such as axonal density, myelination, and fiber coherence. Higher values indicate better integrity of white matter tracts
Measured: Baseline (Week 0) and Post-training (Week 4)
Berg Balance Scale
The Berg Balance Scale (BBS) is a standardized clinical assessment tool designed to evaluate static and dynamic balance abilities, primarily in older adults and individuals with neurological conditions. The scale score ranges form a minimum of 0 to a maximum of 56, with higher scores indicating better balance performance
Measured: Baseline (Week 0) and Post-training (Week 5)
Change in Physical Activity Level (Questionnaires)
The Physical Activity Scale for the Elderly (PASE) is a validated self-report questionnaire designed to quantify physical activity levels in adults aged 65+ through occupational, household, and leisure activities over a 7-day period. The scores ranges from 0-793 with higher score indicating better performance.
Measured: Baseline (Week 0) and Post-training (Week 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start28 Nov 2018
- Primary completion5 Sep 2022
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Tanvi Bhatt, University of Illinois Chicago
- Investigators
- Tanvi S Bhatt, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765398
- Sponsor's protocol ID
- 2018-1257
- Other IDs
- 2P30AG022849-11
- Status last verified
- Jun 2025
- First submitted
- 30 Nov 2018
- Last updated
- 3 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual-reality Based Cognitive-motor-balance (VR-CogMoBal) Training: Examining Behavioral and Neuromarkers for Fall-risk Reduction in Older Adults With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT03765398
- Acronym / sponsor ID
- 2018-1257
- Conditions
- Mild Cognitive Impairment
- Keywords
- Dual-task training, Virtual-reality exergaming, Cognitive-motor-balance training, Mild cognitive impairment, Older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 5 Sep 2022 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 5 Dec 2018 (actual)
- Results
- Posted 3 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Older adults suffer from mild cognitive impairments with a prevalence rate of 3% to 22% and an incidence rate of 1% to 6% per year in the United States. Along with age associated locomotor-balance impairments, such cognitive decline among the elderly is known to increase the risk of falls, reduced physical activity and community integration, thus contributing to long-term disability. Daily living activities comprises of several concurrent motor and cognitive performances (dual-tasking) such as shopping in a supermarket, that requires higher executive cognitive functions and intact locomotor-balance control abilities. Falls during dual-tasking occur mostly due to the interference caused, i.e. during dual-task performances, either one or both task (motor or cognitive) performance is deteriorated that is known as cognitive-motor interference. Given that dual-task performances decline due to age-associated factors, daily living activities are highly challenging and difficult to perform for older adults with mild cognitive impairment. Although there are several conventional methods that incorporate locomotor-balance training, the nature of such interventions does not result in pronounced cognitive gains. Additionally, these interventions lack multi-sensory feedback, and due to the monotonous and repeated task practice of exercises characteristic, individuals do not seem to adhere to therapy leading to less compliance and decreased motivation to exercise training. In order to overcome such barriers, alternate form of therapy with the help of Virtual-reality devices, especially off the shelf commercially available exercise platforms emerged for training purposes. Although there is evidence that VR based training improves locomotor-balance control and is known to implicitly address cognitive functions, there is no knowledge that such VR based training can explicitly address higher executive cognitive functions. Therefore, based on preliminary studies tested the efficacy of cognitive training along with exergaming delivered via the commercially available off the shelf device- Wii-fit Nintendo and demonstrated promising results in improving balance control and cognitive function among the individuals with Chronic Stroke. The study resulted in decreased cognitive-motor interference during dual-task performance thereby exhibiting an improved performance on both cognitive and balance control function. Currently, there is lack of knowledge in determining specific interventions for improving dual-task performances among the older adults with MCI. Given that mild cognitive impaired older adults suffer from both motor and cognitive impairments, there is a need for testing the feasibility of a similar intervention among them and determine the change in the underlying neural biomarkers.
Aim 1: The study is designed to test the feasibility (tolerability, compliance and effectiveness) of VR-CogMoBal training to improve physical function and reduce fall-risk in community-dwelling older adults with mild cognitive deficits by lowering cognitive-motor interference and dual task costs.
Hypothesis: Participants will tolerate the training paradigm and will demonstrate significant improvements in balance, gait, cardiovascular and cognitive performance under dual-task conditions.
Aim 2: To examine if the (VR-CogMoBal) will lead to higher cognitive function post-intervention.
Hypothesis: Post-training compared to pre-training participants will show significantly greater global cognitive function, executive and working memory and decreased cognitive-motor load.
Aim 3: To examine effect of VR-CogMoBal Training on changes in structural and functional connectivity within the cognitive-motor areas in the brain.
Hypothesis: Post-training compared to pre-training, participants will show increased structural and functional connectivity at rest in the default mode network (memory consolidation, self-referential memory), fronto-parietal and supplementary motor areas (motor planning and execution, attention).
Pilot Sub-study aim:
The study aims to monitor the change in the number of steps taken a day before undergoing VR training and 4 weeks post-training.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VR Cognitive-motor-balance training | Experimental | Behavioral: VR Cognitive-motor-balance trainingVirtual 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR Cognitive-motor-balance trainingAlso: VR-CogMoBal, Dual-task trainingThe 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. | Behavioural | VR Cognitive-motor-balance training |
Primary outcome
Change in Maximum Excursion
Time frame: 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.
Change in 4 Meter Walk Test
Time frame: 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.
Change of Accuracy in Letter Number Sequencing
Time frame: 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.
Change in Working Memory
Time frame: 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.
Change in Episodic Memory
Time frame: 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.
Change in Accuracy of Flanker Inhibitory Control and Attention Test
Time frame: 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.
Change in Cognitive Flexibility and Attention
Time frame: 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.
Change in Processing Speed
Time frame: 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.
16 secondary outcomes
Change in Movement Velocity
Time frame: Baseline (Week 0) and Immediate post-training (Week 5)
Changes in End Point Excursion
Time frame: Baseline (Week 0) and post-training (Week 5)
Change in Directional Control
Time frame: Baseline (Week 0) and Post-training (Week 5)
Change in Postural Stability During Reactive Balance Control (Single and Dual-task)
Time frame: Baseline (Week 0) and Post-training (Week 5)
Change in Accuracy of Auditory Stroop
Time frame: Baseline (Week 0) and post-training (Week 5)
Change in Dual-task Cost
Time frame: Baseline (Week 0) and Post-training (Week 5)
Change in Gait Parameters
Time frame: Baseline (Week 0) and post-training (Week 5)
Change in Interference in the Reaction Time
Time frame: Baseline (Week 0) and Post-training (Week 5)
Change in Language Fluency
Time frame: Baseline (Week 0) and Post-training (Week 5)
Change in Interference in Reaction Time
Time frame: Baseline (Week 0) and Post-training (Week 5)
Change in Paired Associative Learning
Time frame: Baseline (Week 0) and Post-training (Week 5)
Change in Spatial Working Memory
Time frame: Baseline (Week 0) and Post-training (Week 5)
Change in Reaction Time
Time frame: Baseline (Week 0) and Post-training (Week 5)
Changes in Fractional Anisotropy
Time frame: Baseline (Week 0) and Post-training (Week 4)
Berg Balance Scale
Time frame: Baseline (Week 0) and Post-training (Week 5)
Change in Physical Activity Level (Questionnaires)
Time frame: Baseline (Week 0) and Post-training (Week 5)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanvi S Bhatt, PhD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR Cognitive-motor-balance training in people with Mild Cognitive Impairment, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Maximum Excursion (time frame: Baseline (Week 0) and Immediate Post-training (Week 5)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.