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| ID | Type | Description | Link |
|---|---|---|---|
| R44AG067909 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| BioSensics | INDUSTRY |
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This longitudinal Phase I feasibility trial combines care-as-usual with a 6-week, single-arm exercise intervention using Tele-Exergame, an interactive, self-administered home-based exercise program aimed at improving cognitive-motor function in individuals with mild cognitive impairment (MCI) and dementia. Fifteen participants will complete two 30-minute sessions per week via the Tele-Exergame platform. Outcomes will be assessed at baseline and post-intervention, with the primary outcome being change in cognition. Secondary outcomes include acceptability, dropout rate, and changes in anxiety.
At the beginning of the 6-week in-home exergaming intervention using the proposed Tele-Exergame system, participants will complete baseline assessments to evaluate system acceptance, cognitive function, and anxiety levels. Acceptance will be measured using the Technology Acceptance Model (TAM) questionnaire-a validated, intention-based Likert scale tool assessing user satisfaction with technology-comprising 11 items (two on ease of use, seven on perceived benefit, and two on attitudes toward use). Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), and anxiety levels will be evaluated using the Beck Anxiety Inventory (BAI). Participants will be instructed to perform leg-raising or foot-flexion exercises, guided by the Tele-Exergame platform, for approximately 30 minutes twice per week over six consecutive weeks. Motion sensors (a motion sensor, which is part of of the Tele-Exergame system) will be worn on the upper leg for leg-raising exercises and on the foot for foot-flexion exercises. At the end of the 6-week intervention, participants will complete post-assessments for acceptance, cognition, and anxiety using the same measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TeleExergame | Experimental | Participants assigned to the Tele-Exergame arm will engage in a tablet-based, home-delivered exercise program focused on foot and ankle mobility, designed specifically for older adults with cognitive impairment or mild dementia. The intervention aims to enhance balance, mobility, and cognitive engagement through structured and gamified motor exercises. Each session includes a sequence of guided exercises such as ankle dorsiflexion and plantarflexion and seated marching, with an emphasis on safe, repetitive movement. Sessions are conducted two times per week, lasting approximately 20-30 minutes each, over a period of 6 weeks. Instructional cues are provided via synchronized audio, images, and text on a user-friendly tablet interface. A motion sensor worn on the foot tracks movement in real time, delivering instant feedback on range of motion and task completion. Exercise performance and adherence data are securely transmitted to a cloud-based server for remote remote monitoring. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| home-based self-administered interactive exercise | Device | The Tele-Exergame system delivers a structured foot and ankle exercise program tailored for individuals with cognitive impairment or mild dementia to support balance and cognitive function. Exercises such as leg raising and foot flexion are guided through audio, visual, and text prompts on a tablet. A foot-mounted motion sensor provides real-time feedback to ensure proper range of motion, while exercise data are securely streamed to the cloud for remote monitoring of adherence. The system also includes a telemedicine interface to enable remote support and education when needed. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Cognitive Function at 6 Weeks Compared to Baseline | Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), a validated 30-point screening tool designed to detect mild cognitive impairment and early dementia. The MoCA evaluates multiple cognitive domains, including memory, attention, language, visuospatial abilities, executive function, and orientation. Scores range from 0 to 30, with higher scores indicating better cognitive performance. The MoCA will be administered at baseline and at 6 weeks. The outcome will be reported as the percentage change in total MoCA score from baseline to 6 weeks, calculated as: [(Week 6 Score - Baseline Score) / Baseline Score] × 100. A positive percentage indicates improved cognitive performance. | Baseline and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | To evaluate participant acceptance of the Tele-Exergame system, the Technology Acceptance Model (TAM) questionnaire was administered. TAM is an intention-based framework widely used to assess user satisfaction and acceptance of new technologies. The questionnaire included 31 items: 15 assessed perceived ease of use, 11 evaluated perceived benefits, and 5 measured attitudes toward use. Responses were rated on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree), resulting in a total score range of 0 to 124. A score of 93 or higher was considered indicative of an acceptable level of program acceptance. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36498431 | Result | Park C, Mishra RK, York MK, Enriquez A, Lindsay A, Barchard G, Vaziri A, Najafi B. Tele-Medicine Based and Self-Administered Interactive Exercise Program (Tele-Exergame) to Improve Cognition in Older Adults with Mild Cognitive Impairment or Dementia: A Feasibility, Acceptability, and Proof-of-Concept Study. Int J Environ Res Public Health. 2022 Dec 6;19(23):16361. doi: 10.3390/ijerph192316361. |
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This study was submitted as part of an NIH SBIR project with a subaward from BioSensics LLC. Individual-level data will be shared with permission from BioSensics LLC based on the contract agreement. However, aggregated results for all participants will be published and reported.
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| ID | Title | Description |
|---|---|---|
| FG000 | TeleExergame | Participants in the Tele-Exergame arm will use a home-based, tablet-guided exercise program, called TeleExergame, designed to improve foot and ankle mobility, balance, and cognitive function in older adults with cognitive impairment or mild dementia. The 6-week program consists of two 20-30 minute sessions per week, featuring safe, repetitive exercises such as foot flexion, ankle dorsiflexion, and seated marching. Instructions are provided through synchronized audio, visual, and text prompts. A foot-worn motion sensor tracks movements in real time, offering immediate feedback and securely transmitting adherence and performance data to a cloud server for remote monitoring. The system also supports telemedicine-based coaching and education when needed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | TeleExergame | Participants used a home-based, tablet-guided exercise program, called TeleExergame, designed to improve foot and ankle mobility, balance, and cognitive function in older adults with cognitive impairment or mild dementia. The 6-week program consists of two 20-30 minute sessions per week, featuring safe, repetitive exercises such as foot flexion, ankle dorsiflexion, and seated marching. Instructions are provided through synchronized audio, visual, and text prompts. A foot-worn motion sensor tracks movements in real time, offering immediate feedback and securely transmitting adherence and performance data to a cloud server for remote monitoring. The system also supports telemedicine-based coaching and education when needed. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage Change in Cognitive Function at 6 Weeks Compared to Baseline | Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), a validated 30-point screening tool designed to detect mild cognitive impairment and early dementia. The MoCA evaluates multiple cognitive domains, including memory, attention, language, visuospatial abilities, executive function, and orientation. Scores range from 0 to 30, with higher scores indicating better cognitive performance. The MoCA will be administered at baseline and at 6 weeks. The outcome will be reported as the percentage change in total MoCA score from baseline to 6 weeks, calculated as: [(Week 6 Score - Baseline Score) / Baseline Score] × 100. A positive percentage indicates improved cognitive performance. | Posted | Mean | Standard Deviation | percentage change | Baseline and 6 weeks |
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6 weeks
The following adverse events were monitored: muscle strain, joint pain, tendonitis, cramps, dizziness, headache, palpitations, chest discomfort, shortness of breath, falls, sprains, nausea, fatigue, weakness, excessive sweating, and exercise intolerance. Serious events included dementia progression, hospitalization, accidents preventing exercise, and death.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TeleExergame | Participants used a home-based, tablet-guided exercise program, called TeleExergame, designed to improve foot and ankle mobility, balance, and cognitive function in older adults with cognitive impairment or mild dementia. The 6-week program consists of two 20-30 minute sessions per week, featuring safe, repetitive exercises such as foot flexion, ankle dorsiflexion, and seated marching. Instructions are provided through synchronized audio, visual, and text prompts. A foot-worn motion sensor tracks movements in real time, offering immediate feedback and securely transmitting adherence and performance data to a cloud server for remote monitoring. The system also supports telemedicine-based coaching and education when needed |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bijan Najafi | Baylor College of Medicine | 424-467-7127 | najafi.bijan@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 22, 2021 | Jun 25, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 11, 2019 | Jun 25, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D008569 | Memory Disorders |
| D009043 | Motor Activity |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
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All participants receive the same intervention: a self-administered home exercise program delivered via an interactive tablet-based system (Tele-Exergame) designed to provide supportive care for individuals with mild cognitive impairment or early dementia.
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| week 6 |
| Percentage Change in Anxiety Levels at 6 Weeks Compared to Baseline | Anxiety will be assessed using the Beck Anxiety Inventory (BAI), a 21-item self-report questionnaire that measures the severity of anxiety symptoms. Each item is scored on a scale from 0 (not at all) to 3 (severely), resulting in a total score ranging from 0 to 63, with higher scores indicating greater anxiety. The BAI will be administered at baseline and at 6 weeks. The outcome will be reported as the percentage change in total BAI score from baseline to 6 weeks, calculated as: [(Week 6 Score - Baseline Score) / Baseline Score] × 100. A negative percentage indicates a reduction in anxiety symptoms | baseline and week 6 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Acceptability | To evaluate participant acceptance of the Tele-Exergame system, the Technology Acceptance Model (TAM) questionnaire was administered. TAM is an intention-based framework widely used to assess user satisfaction and acceptance of new technologies. The questionnaire included 31 items: 15 assessed perceived ease of use, 11 evaluated perceived benefits, and 5 measured attitudes toward use. Responses were rated on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree), resulting in a total score range of 0 to 124. A score of 93 or higher was considered indicative of an acceptable level of program acceptance. | Posted | Mean | Standard Deviation | score on a scale | week 6 |
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| Secondary | Percentage Change in Anxiety Levels at 6 Weeks Compared to Baseline | Anxiety will be assessed using the Beck Anxiety Inventory (BAI), a 21-item self-report questionnaire that measures the severity of anxiety symptoms. Each item is scored on a scale from 0 (not at all) to 3 (severely), resulting in a total score ranging from 0 to 63, with higher scores indicating greater anxiety. The BAI will be administered at baseline and at 6 weeks. The outcome will be reported as the percentage change in total BAI score from baseline to 6 weeks, calculated as: [(Week 6 Score - Baseline Score) / Baseline Score] × 100. A negative percentage indicates a reduction in anxiety symptoms | Posted | Mean | Standard Deviation | percentage change | baseline and week 6 |
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| 0 |
| 15 |
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| 15 |
| 0 |
| 15 |
This is an NIH SBIR grant with BioSensics LLC as the prime awardee. A subaward contract agreement between BioSensics LLC and Baylor College of Medicine is in place, which may restrict the sharing of certain results deemed confidential.
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |