Back to resultsExergame Balance Training for Patients With Mild Cognitive Impairment
Primary Purpose
Mild Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Low complexity Exergaming group
Moderate complexity Exergaming group
High complexity Exergaming group
Control Group
Sponsored by
About this trial
This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Brain Activity, Executive Functions, Exergame balance training, Mild Cognitive Impairment
Eligibility 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.
Sites / Locations
- Railway General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Low complexity Exergame balance training group
Moderate complexity exergame balance training group
High complexity exergame balance training group
Control group
Arm Description
Wobble board based exergame balance training, the game complexity will be low for this group.
Wobble board based exergame balance training, game complexity will be moderate for this group.
Wobble board based exergame balance training, game complexity will be high for this group.
Wii fit based Exergame training on a stable surface
Outcomes
Primary Outcome Measures
Stroop test
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.
Trails Test
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.
Digit Span Forward and Backward
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.
Montreal Cognitive Assessment
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.
Alzheimer's disease Assessment Scale
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.
Time Up and Go Test
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.
Mini Brief Balance Evaluation Systems
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.
Smartphone Gait and Balance Application
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.
Force Plate
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.
Gait Speed Assessment
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.
Electroencephalography
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.
Blood Biomarkers
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
Voice Recording
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.
Full Information
NCT ID
NCT04959383
First Posted
June 26, 2021
Last Updated
May 26, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT04959383
Brief Title
Exergame Balance Training for Patients With Mild Cognitive Impairment
Official Title
Exergame Balance Training for Pre Frontal Brain Activity and Executive Functioning in Patients With Mild Cognitive Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 23, 2021 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Brain Activity, Executive Functions, Exergame balance training, Mild Cognitive Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low complexity Exergame balance training group
Arm Type
Experimental
Arm Description
Wobble board based exergame balance training, the game complexity will be low for this group.
Arm Title
Moderate complexity exergame balance training group
Arm Type
Experimental
Arm Description
Wobble board based exergame balance training, game complexity will be moderate for this group.
Arm Title
High complexity exergame balance training group
Arm Type
Experimental
Arm Description
Wobble board based exergame balance training, game complexity will be high for this group.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Wii fit based Exergame training on a stable surface
Intervention Type
Other
Intervention Name(s)
Low complexity Exergaming group
Other Intervention Name(s)
Group A
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Moderate complexity Exergaming group
Other Intervention Name(s)
Group B
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
High complexity Exergaming group
Other Intervention Name(s)
Group C
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control Group
Other Intervention Name(s)
Group D
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stroop test
Description
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.
Time Frame
8th weeks
Title
Trails Test
Description
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.
Time Frame
8th weeks
Title
Digit Span Forward and Backward
Description
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.
Time Frame
8th weeks
Title
Montreal Cognitive Assessment
Description
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.
Time Frame
8th weeks
Title
Alzheimer's disease Assessment Scale
Description
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.
Time Frame
8th weeks
Title
Time Up and Go Test
Description
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.
Time Frame
8th weeks
Title
Mini Brief Balance Evaluation Systems
Description
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.
Time Frame
8th weeks
Title
Smartphone Gait and Balance Application
Description
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.
Time Frame
8th weeks
Title
Force Plate
Description
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.
Time Frame
8th weeks
Title
Gait Speed Assessment
Description
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.
Time Frame
8th weeks
Title
Electroencephalography
Description
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.
Time Frame
8th week
Title
Blood Biomarkers
Description
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.
Time Frame
8th weeks
Secondary Outcome Measure Information:
Title
Voice Recording
Description
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.
Time Frame
8th weeks
Other Pre-specified Outcome Measures:
Title
MRI of Brain
Description
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.
Time Frame
8th weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imran Amjad, PhD
Organizational Affiliation
Riphah international university.pakistan
Official's Role
Study Chair
Facility Information:
Facility Name
Railway General Hospital
City
Rawalpindi
ZIP/Postal Code
46000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
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Exergame Balance Training for Patients With Mild Cognitive Impairment
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