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Exergame Balance Training for Patients With Mild Cognitive Impairment

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ClinicalTrials.gov Identifier: NCT04959383
Recruitment Status : Recruiting
First Posted : July 13, 2021
Last Update Posted : September 30, 2021
Sponsor:
Information provided by (Responsible Party):
Riphah International University

Brief Summary:
This study will be a randomized control trial, which will be conducted on older adults with mild cognitive impairment. A specially designed Exergame balance training will be used for cognitive enhancement in patients with MCI. This training will determine the improvement in executive functioning, balance, speech and electrical activity of the brain.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Other: Low complexity Exergaming group Other: Moderate complexity Exergaming group Other: High complexity Exergaming group Other: Control Group Not Applicable

Detailed Description:
From last few years the line of research for cognitive enhancement has been shifted towards balance training as balance training is considered to directly stimulate the neuronal activity as compare to aerobic training. The previous finding also proposed that in aerobic training it is the intensity of training that improves the neuroplasticity and cognition but it is the neuro-cognitive demands and complexity of the task in balance training that affects the relationship between exercise and cognition in balance training. There is a need to determine the effect of the level of complexity of balance training on neural activity and executive functioning. Exergame augmented balance training is expected to have a better physical and cognitive outcome as compared to traditional balance training.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exergame Balance Training for Pre Frontal Brain Activity and Executive Functioning in Patients With Mild Cognitive Impairment
Actual Study Start Date : September 23, 2021
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2022

Arm Intervention/treatment
Experimental: Low complexity Exergame balance training group
Wobble board based exergame balance training, the game complexity will be low for this group.
Other: Low complexity Exergaming group
This group will receive 30 minutes of Exergame Balance Training on Modified wobble board 3 times a week for 8 weeks. Wobble board will be able to rock in all direction with Weight Transfer. Wobble board based exergame balance training group game complexity will be kept low for this group.
Other Name: Group A

Experimental: Moderate complexity exergame balance training group
Wobble board based exergame balance training, game complexity will be moderate for this group.
Other: Moderate complexity Exergaming group
This group will receive 30 minutes of Exergame Balance Training on Modified wobble board 3 times a week for 8 weeks. Wobble board will be able to rock in all direction with Weight Transfer. Wobble board based exergame balance training group game complexity will be kept moderate for this group.
Other Name: Group B

Experimental: High complexity exergame balance training group
Wobble board based exergame balance training, game complexity will be high for this group.
Other: High complexity Exergaming group
This group will receive 30 minutes of Exergame Balance Training on Modified wobble board 3 times a week for 8 weeks. Wobble board will be able to rock in all direction with Weight Transfer. Wobble board based exergame balance training group game complexity will be kept high for this group.
Other Name: Group C

Active Comparator: Control group
Wii fit based Exergame training on a stable surface
Other: Control Group
This group will receive 30 minutes of Exergame Balance Training on Modified wobble board 3 times a week for 8 weeks. This group will receive exergame balance training on Wii fit. Participants in this group will play Soccer Heading, Ski Slalom, Ski Jump, Table Tilt, Tightrope Walk, Balance Bubble, Penguin Slide and Snowboard Slalom game.
Other Name: Group D




Primary Outcome Measures :
  1. Stroop test [ Time Frame: 8th weeks ]
    Stroop test measure attention, processing speed, cognitive flexibility, and working memory. This test has good specificity (0.85-0.90). Coloured squares (red, green, blue) are presented in rows first (Stroop A), followed by those colour words typed in black ink (Stroop B), followed by incongruent colour words (Stroop C; in which participants will be asked to name the colour of the ink while ignoring the written word). A ratio will be computed to isolate the executive function component of the task. Assessment will be done at baseline, after the 4th and 8th week.

  2. Trails Test [ Time Frame: 8th weeks ]
    Trails test is used to assess selective attention, mental flexibility, visual-spatial skills and motor speed. It requires participants to connect numbered circles in ascending order. Color trails-2, requires individuals to connect numbered circles in consecutive order while also alternating the alphabets of the circle. Reliability and validity are adequate. Higher ratios represent a better executive function. Assessment will be done at baseline, after the 4th and 8th week.

  3. Digit Span Forward and Backward [ Time Frame: 8th weeks ]
    This test measures working memory's number storage capacity. It requires participants to first listen to a list of numbers and repeat them, with the string length increasing to the maximum of their ability. Digit Span Backward, requires repeating a string of numbers in reverse order. Continuing the pattern above to isolate the executive function component, the ratio of the typically smaller sum of correct interference trials on Digit Span Backward, divided by the typically greater sum of correct basic attention trials on Digit Span Forward. Assessment will be done at baseline, after the 4th and 8th week.

  4. Montreal Cognitive Assessment [ Time Frame: 8th weeks ]
    The MoCA was administered at baseline to characterize the sample as either normative aging or "screened as MCI" The MoCA consists of eight different subtests to assess overall cognitive impairment. Scores below 24 out of 30 were used to categorize MCI. This scale has a good reliability with Cronbach's alpha of 0.905. Its sensitivity is 88% and specificity is 98%. Assessment will be done at baseline, after the 4th and 8th week.

  5. Alzheimer's disease Assessment Scale [ Time Frame: 8th weeks ]
    Alzheimer's disease Assessment Scale will be used for Immediate and Delayed Recall Participants shows a list of 11 words on cards and they recall as many as they are able immediately and also after a delay interval. The number of errors/omissions comprises the score, so lower scores are better. It is a reliable tool with Cronbach's alpha of 0.83. Assessment will be done at baseline, after the 4th and 8th week.

  6. Time Up and Go Test [ Time Frame: 8th weeks ]
    The participants rise from sitting, walk 10 feet, turn around and return to the sitting position. The time it takes to complete the task is the score. Lower scores are better. It has a very good validity of 0.857. Assessment will be done at baseline, after the 4th and 8th week.

  7. Mini Brief Balance Evaluation Systems [ Time Frame: 8th weeks ]
    It is a reliable and valid tool. The mini Balance Evaluation Systems Test (BES Test) is a 14-item clinical balance assessment tool, developed to assess balance across six contexts of postural control: mechanical constraints, limits of stability, postural response to the induced loss of balance, sensory orientation, and gait. Assessment will be done at baseline, after the 4th and 8th week.

  8. Smartphone Gait and Balance Application [ Time Frame: 8th weeks ]
    The system consists of the following three components: i) a smartphone that has an embedded accelerometer, ii) a belt to house the phone on the lower back, iii) and a smartphone balance application. There are six different tasks that the subject have to perform with the system, like, normal walking up to 6 meters, walking with head movement, standing with eyes open and close and standing on a compromised surface with eyes open and close. This app. will calculate mediolateral and anterior-posterior sway during each task. Assessment will be done at baseline, after the 4th and 8th week.

  9. Force Plate [ Time Frame: 8th weeks ]
    Force Plate is a reliable and valid tool for balance assessment (ICC=0.8). In the force platform test, the mean velocity of the mediolateral (ML) and anterior-posterior (AP) movement of the COP will be calculated (mm/s) according to the displacement of the COP during each second. The mean moment of velocity (m m2/s) will be calculated as the mean of the areas covered by COP movement during each second of the Force Platform. Assessment will be done at baseline, after the 4th and 8th week.

  10. Gait Speed Assessment [ Time Frame: 8th weeks ]
    Self-selected gait speed (SSGS), fast gait speed (FGS), Cadence are considered to be decreased in patients with MCI. Gait speed will be assessed over 6 meters, and usual- and fast-pace walking mode. The test will be repeated twice with the mean of the two trials will be used for scoring purposes. Participants will be instructed to walk from a standing start at a pace that was normal and comfortable for them or to walk as fast as they could until they reached the end of the marked path. The participants will be asked to stop when their foot contacted the floor at the end of the walking course. Assessment will be done at baseline, after the 4th and 8th week.

  11. Electroencephalography [ Time Frame: 8th week ]
    An electroencephalography scalp electro-voltage activity (sampling frequency: 128Hz, bandpass hardware filter:1-32Hz) will be used. Delta, theta, beta1 and beta2 will be measured in eye open and closed state. Assessment will be done at baseline, after the 4th and 8th week.

  12. Blood Biomarkers [ Time Frame: 8th weeks ]
    The blood biomarkers will be assessed. A 5-mL blood sample will be obtained from the patient. The blood samples will be withdrawn for analysis of serum. The blood samples will be centrifuged. Samples will be and stored at - 80 °C for further serum marker assays. Assessment will be done at baseline, after the 4th and 8th week. Blood biomarkers BDNF, IGF-2, VEGF, TNFα, total-tau, amyloid beta-42, a-Synuclein, IL-10, IL1 and IL4 will be measured.


Secondary Outcome Measures :
  1. Voice Recording [ Time Frame: 8th weeks ]

    The Voice of all the patients will be recorded. Through voice recording pause length, verbal reaction time, and amount of silence will be assessed.

    Each participant performed four spoken tasks. The tasks consisted of a counting backward task, a sentence repeating task, an image description task, and a verbal fluency task. Each task will be recorded entirely to extract specific vocal features, including pause length, verbal reaction time, and amount of silence. Assessment will be done at baseline, after the 4th and 8th week.



Other Outcome Measures:
  1. MRI of Brain [ Time Frame: 8th weeks ]
    MRI Brain of patients will be carried out to evaluate the Gray matter volume in the hippocampus, prefrontal cortex, dorsolateral prefrontal cortex, the superior temporal sulcus and the anterior cingulate cortex. Assessment will be done at baseline, after the 4th and 8th week.



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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 55
  • MoCA =20-24
  • CDR ( dementia rating scale)≤ 1.0
  • No unstable disease precluding planned exercise.
  • Able to see and hear sufficiently to participate in planned physical and computer-based cognitive training.
  • Patients score >45 on Berg Balance Scale.

Exclusion Criteria:

  • Participation in any cognitive training activity
  • Participation in > 150 min/wk of moderate or greater intensity planned exercise of any kind.
  • Non-ambulatory or major mobility disorder.
  • Other neurological conditions associated with cognitive impairment such as stroke, Parkinson disease, and head injury
  • Any clinically significant psychiatric condition, current drug or alcohol abuse, or laboratory abnormality that would interfere with the ability to participate in the study.
  • Individual with any musculoskeletal impairment.
  • Unwillingness to participate.

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): NCT04959383


Contacts
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Contact: Aruba Saeed 03344399403 arooba.saeed@gmail.com

Locations
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Pakistan
Railway General Hospital Recruiting
Rawalpindi, Pakistan, 46000
Contact: Imran Amjad, PhD    0332 4390125    imran.amjad@riphah.edu.pk   
Sub-Investigator: Aruba Saeed, PhD         
Sponsors and Collaborators
Riphah International University
Investigators
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Study Chair: Imran Amjad, PhD Riphah international university.pakistan
Publications:

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Responsible Party: Riphah International University
ClinicalTrials.gov Identifier: NCT04959383    
Other Study ID Numbers: REC/1954 Aruba Saeed
First Posted: July 13, 2021    Key Record Dates
Last Update Posted: September 30, 2021
Last Verified: September 2021
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 Riphah International University:
Brain Activity
Executive Functions
Exergame balance training
Mild Cognitive Impairment
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders