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

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ClinicalTrials.gov Identifier: NCT03765398
Recruitment Status : Recruiting
First Posted : December 5, 2018
Last Update Posted : December 5, 2018
Sponsor:
Collaborators:
Midwest Roybal Center
National Institute on Aging (NIA)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Illinois at Chicago

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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Behavioral: VR Cognitive-motor-balance training Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 28, 2018
Estimated Primary Completion Date : December 17, 2019
Estimated Study Completion Date : June 16, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.
Other Names:
  • VR-CogMoBal
  • Dual-task training




Primary Outcome Measures :
  1. Change in Movement velocity [ Time Frame: Baseline (Week 0) and Immediate Post-training (Week 5) ]
    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.

  2. Change in end point excursion [ Time Frame: Baseline (Week 0) and Immediate Post-training (Week 5) ]
    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.

  3. 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.

  4. Change in directional control [ Time Frame: Baseline (Week 0) and Immediate Post-training (Week 5) ]
    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.

  5. Change in postural stability during reactive balance control (single and dual-task) [ Time Frame: Baseline (Week 0) and Immediate Post-training (Week 5) ]
    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.

  6. 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.

  7. Change in gait parameters [ Time Frame: Baseline (Week 0) and Immediate Post-training (Week 5) ]
    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.

  8. 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.

    Accuracy (number of correct responses out of the total responses) of letter number sequencing will be calculated. Higher accuracy indicates better performance.


  9. Change in accuracy of Auditory stroop [ Time Frame: Baseline (Week 0) and Immediate Post-training (Week 5) ]

    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.


  10. Change in dual-task cost [ Time Frame: Baseline (Week 0) and Immediate Post-training (Week 5) ]
    Dual-task motor and cognitive cost will be calculated using the formula- [(Dual-task performance- Single Task performance)/Single task performance]. This will be calculated for dual-task performance during intentional postural sway, reactive balance control and gait conditions. Lower cost indicates better performance.

  11. Change in Interference in the reaction time [ Time Frame: Baseline (Week 0) and Immediate Post-training (Week 5) ]
    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 indicate better performance.

  12. Change in language fluency [ Time Frame: Baseline (Week 0) and Immediate Post-training (Week 5) ]
    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.

  13. Change in reaction time [ Time Frame: Baseline (Week 0) and Immediate Post-training (Week 5) ]
    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 indicate better performance.

  14. Change in paired associated learning [ Time Frame: Baseline (Week 0) and Immediate Post-training (Week 5) ]
    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 indicate better performance.

  15. Change in spatial working memory [ Time Frame: Baseline (Week 0) and Immediate Post-training (Week 5) ]
    Spatial working memory via unveil the star task will be administered. Performance will be identified via the total time (in seconds) to complete the task. Lower time indicate better performance.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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 computer and scores are computer generated. Higher value indicate better performance.

  21. Changes in fractional anisotropy [ Time Frame: Baseline (Week 0) and Immediate Post-training (Week 5) ]
    Image acquisition will be performed in a 3T and 1.5T Magnetic resonance scanner (MR 750, GE healthcare, Milwaukee). Fractional anisotropy (FA) is a scalar value ranging from 0-1 and change from pre- to post-training will compared to determine the structural and functional connectivity. Increase in FA values post-training will indicate positive results of training.


Secondary Outcome Measures :
  1. Berg Balance scale [ Time Frame: Baseline (Week 0) and Immediate Post-training (Week 5) ]
    Assess static and dynamic balance. This scale consists of the participant transferring from one chair to another, reaching forward, stepping up and down from a stepping stool, standing with eyes closed and open, one leg standing. It is a 14-item scale with each item score ranging from 0-4. Performance on the scale will be calculated on a total of 56. Less than 45 will indicate greater risk of falling.

  2. Change in physical activity level (Questionnaires) [ Time Frame: Baseline (Week 0) and Immediate Post-training (Week 5) ]
    Questionnaires such as Physical Activity Scale for elderly and activity specific balance confidence scale will be self-reported by the participant. Activity specific balance confidence scale consists of 16 items, and each item score ranges from 0-100. The total score with 0 confidence indicates no confidence and 100 with complete confidence.

  3. Change in physical activity level [ Time Frame: Baseline (Week 0) and 4 weeks Post-training (Week 9) ]
    Average number of steps taken a day by the individual prior to and after training



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03765398


Contacts
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Contact: Lakshmi Kannan, MS PT 3124133175 lkanna2@uic.edu

Locations
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United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Tanvi S Bhatt, PhD    312-355-4443    tbhatt6@uic.edu   
Contact: Lakshmi Kannan, MS    3124133175    lkanna2@uic.edu   
Sponsors and Collaborators
University of Illinois at Chicago
Midwest Roybal Center
National Institute on Aging (NIA)
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Tanvi S Bhatt, PhD University of Illinois at Chicago

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Responsible Party: University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT03765398     History of Changes
Other Study ID Numbers: 2018-1257
2P30AG022849-11 ( U.S. NIH Grant/Contract )
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Illinois at Chicago:
Dual-task training
Virtual-reality exergaming
Cognitive-motor-balance training
Mild cognitive impairment
Older adults

Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders