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| ID | Type | Description | Link |
|---|---|---|---|
| 5R44DC017408-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
| University of Kansas Medical Center | OTHER |
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The aim of this study is to test whether when using the Vestibular Rehabilitation App older patients perform rehabilitation in a similar manner as when directly instructed by a clinician. A secondary goal is to evaluate usability and enjoyment of the app.
The main aim of this study is to test the prototype Vestibular Rehabilitation App (that has been specifically developed for this study) in the lab setting to evaluate if patients perform exercises with the app in a similar manner as when performing exercises in the traditional manner without the app. Errors in exercise performance identified by the app will be compared to those identified by a physical therapist. A secondary aim is to get feedback on enjoyment and ease of use of the Vestibular Rehabilitation App.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trials with Vestibular Rehabilitation App | Experimental | All participants underwent the same experiment. They will performed exercises with the Vestibular Rehabilitation App as well as without the App. The order was randomized. This arm describes the results of the trials where exercises were performed with the Vestibular Rehabilitation App. |
|
| Trials without Vestibular Rehabilitation App | Experimental | All participants underwent the same experiment. They will performed exercises with the Vestibular Rehabilitation App as well as without the App. The order was randomized. This arm describes the results of the trials where exercises were performed without the Vestibular Rehabilitation App. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vestibular rehabilitation app | Device | Delivery of vestibular rehabilitation through an app on a tablet or other portable device. The app takes patients through their rehabilitation session that has been prescribed by a clinician. Exercises are presented in the forms of games that are controlled by head or torso motion via a motion sensor that is placed on that body part. Data on the motion of the patient are calculated from sensor data and sent over the cloud for the clinician to access remotely. |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Usefulness | The ease of use of information technology questionnaire is used to rate usefulness and perceived ease of use of the Vestibular Rehabilitation app. These are rated on a scale of 1-7, with 1 being the most positive response, 4 being a neutral response and 7 being the most negative response. | Immediately after the testing |
| User Interface Satisfaction Questionnaire Outcomes | The questionnaire for user interface satisfaction (QUIS) is used to rate the Vestibular Rehabilitation app on use of its software and screen. These are rated on a scale of 0-9, with 9 being the most positive response and 0 being the most negative response. | Immediately after the testing |
| Use Intention, Motivation and Enjoyment | A questionnaire on use intention, motivation, and enjoyment is used to rate the Vestibular Rehabilitation app on the use intention, motivation and enjoyment of the app. These are rated on a scale of 1-7, with 1 being the most positive response, 4 being a neutral response and 7 being the most negative response. | Immediately after the testing |
| Change in Head Angle With the App | The IMU sensor data collected during the exercise performance with and without the Vestibular Rehabilitation App (collected in the same lab visit on the same group of participants) were analyzed to calculate peak head angles. These were analyzed to identify differences for the conditions with and without the Vestibular Rehabilitation App. | During the testing with the app and during the testing without the app (up to 90 minutes) |
| Change in Range of Motion With the App | The IMU sensor data collected during the exercise performance with and without the Vestibular Rehabilitation App (collected in the same lab visit on the same group of participants) were analyzed to calculate head range of motion values. These were analyzed to identify differences for the conditions with and without the Vestibular Rehabilitation App |
| Measure | Description | Time Frame |
|---|---|---|
| Open Ended Feedback | Participants will be asked for open ended feedback after the testing with and without the Vestibular Rehabilitation App. Discussions will be guided with questions. The questions were as follows: 1) Describe your overall experience as you used the app today?; 2) Explain the positive features of the app as you did your exercises?; 3) Describe the negative features of the app as you did your exercises today?; 4) What changes would you like to see in the app to support you as you do your exercises?; 5) Do you see any barriers to using the app while doing your exercises at home? |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paulien Roos, PhD | CFD Research Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35280295 | Background | DSilva LJ, Skop KM, Pickle NT, Marschner K, Zehnbauer TP, Rossi M, Roos PE. Use of Stakeholder Feedback to Develop an App for Vestibular Rehabilitation-Input From Clinicians and Healthy Older Adults. Front Neurol. 2022 Feb 24;13:836571. doi: 10.3389/fneur.2022.836571. eCollection 2022. | |
| Background | Davis, F. D. Perceived Usefulness, Perceived Ease of Use, and User Acceptance of Information Technology. MIS Quarterly. 1989; 13(3): 319-340. | ||
| Background | Chin, J.P., Diehl, V.A., and Norman, K.L. Development of a tool measuring user satisfaction of the human-computer interface. CHI '88: Proceedings of the SIGCHI Conference on Human Factors in Computing Systems. 1988; 213-218. | ||
| 24966165 |
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All resources developed for this project will be presented at conferences and published in the literature where possible. Whenever possible the investigators will include supplemental data (de-identified) in the online versions of their publications to most fully disseminate our results. Also, resources and de-identified data will be made available, whenever possible and appropriate, to qualified persons upon request.
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Data will be available upon request after they have been published
Upon request
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A total of 40 participants were recruited and participated in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Older Adults With Dizziness | All participants underwent the same experiment. They performed exercises with the Vestibular Rehabilitation App as well as without the App. The order was randomized. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Population | All participants underwent the same experiment. They will performed exercises with the Vestibular Rehabilitation App as well as without the App. The order was randomized. In the rest of the reporting the overall study population is presented in two different arms, "Trials with Vestibular Rehabilitation App" and "Trials without Vestibular Rehabilitation App". These are the same participants and all participated in both arms. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Perceived Usefulness | The ease of use of information technology questionnaire is used to rate usefulness and perceived ease of use of the Vestibular Rehabilitation app. These are rated on a scale of 1-7, with 1 being the most positive response, 4 being a neutral response and 7 being the most negative response. | Posted | Mean | Standard Deviation | units on a scale | Immediately after the testing |
|
90 minutes
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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 | Older Adults With Dizziness | Clinical trial only has one arm or participant group. All participants undergo the same experiment. They will perform exercises with the Vestibular Rehabilitation App as well as without the App. The order is randomized. Vestibular rehabilitation app: Delivery of vestibular rehabilitation through an app on a tablet or other portable device. The app takes patients through their rehabilitation session that has been prescribed by a clinician. Exercises are presented in the forms of games that are controlled by head or torso motion via a motion sensor that is placed on that body part. Data on the motion of the patient are calculated from sensor data and sent over the cloud for the clinician to access remotely. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paulien Roos | CFD Research Corporation | 256 715 6817 | paulien.roos@cfd-research.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 4, 2022 | Feb 6, 2024 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 4, 2022 | Feb 6, 2024 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 4, 2022 | Feb 6, 2024 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D015837 | Vestibular Diseases |
| D004244 | Dizziness |
| ID | Term |
|---|---|
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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|
| Traditional Physical Therapy | Other | Delivery of vestibular rehabilitation through traditional physical therapy. |
|
| During the testing with the app and during the testing without the app (up to 90 minutes) |
| Change in Head Motion Frequency With the App | The IMU sensor data collected during the exercise performance with and without the Vestibular Rehabilitation App (collected in the same lab visit on the same group of participants) were analyzed to calculate frequency of head motion. These were analyzed to identify differences for the conditions (arms) with and without the Vestibular Rehabilitation App | During the testing with the app and during the testing without the app (up to 90 minutes) |
| Change in Balance Outcome With the App - Weight Shift Exercise | The IMU sensor data collected during the exercise performance with and without the Vestibular Rehabilitation App (collected in the same lab visit on the same group of participants) were analyzed to calculate range of motion in different directions during the weight shift balance exercise (in degrees). These were analyzed to identify differences for the conditions with and without the Vestibular Rehabilitation App | During the testing with the app and during the testing without the app (up to 90 minutes) |
| Change in Head Angle With Feedback | The IMU sensor data collected during the exercise performance with the Vestibular Rehabilitation App will be analyzed to calculate peak head angles. Averages will be calculated for time windows before and after feedback on exercise performance is given. This will be analyzed to identify differences before and after feedback has been given. | During the testing with the app (up to 45 minutes) |
| Change in Range of Motion With Feedback | The IMU sensor data collected during the exercise performance with the Vestibular Rehabilitation App will be analyzed to calculate range of motion values. Averages will be calculated for time windows before and after feedback on exercise performance is given. This will be analyzed to identify differences before and after feedback has been given. | During the intervention with the app (up to 45 minutes) |
| Change in Angular Velocity With Feedback | The IMU sensor data collected during the exercise performance with the Vestibular Rehabilitation App will be analyzed to calculate angular velocity values . Averages will be calculated for time windows before and after feedback on exercise performance is given. This will be analyzed to identify differences before and after feedback has been given. | During the intervention with the app (up to 45 minutes) |
| Change in Balance Outcome With Feedback | The IMU sensor data collected during the exercise performance with the Vestibular Rehabilitation App will be analyzed to calculate balance measures (jerk). Averages will be calculated for time windows before and after feedback on exercise performance is given. This will be analyzed to identify differences before and after feedback has been given. | During the intervention with the app (up to 45 minutes) |
| Error Identification Differences | The exercise errors that are identified by the Vestibular Rehabilitation App and those identified by the physical therapist will be compared. | During the intervention with the app (up to 45 minutes) |
| Change in Balance Outcome With the App - Single Leg Balance | The IMU sensor data collected during the exercise performance with and without the Vestibular Rehabilitation App (collected in the same lab visit on the same group of participants) were analyzed to calculate balance measure fluency (a non-dimensional derivative of jerk). This was analyzed to identify differences for the conditions with and without the Vestibular Rehabilitation App | During the testing with the app and during the testing without the app (up to 90 minutes) |
| Immediately after the intervention |
| Background |
| van Het Reve E, Silveira P, Daniel F, Casati F, de Bruin ED. Tablet-based strength-balance training to motivate and improve adherence to exercise in independently living older people: part 2 of a phase II preclinical exploratory trial. J Med Internet Res. 2014 Jun 25;16(6):e159. doi: 10.2196/jmir.3055. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | User Interface Satisfaction Questionnaire Outcomes | The questionnaire for user interface satisfaction (QUIS) is used to rate the Vestibular Rehabilitation app on use of its software and screen. These are rated on a scale of 0-9, with 9 being the most positive response and 0 being the most negative response. | Posted | Mean | Standard Deviation | units on a scale | Immediately after the testing |
|
|
|
| Primary | Use Intention, Motivation and Enjoyment | A questionnaire on use intention, motivation, and enjoyment is used to rate the Vestibular Rehabilitation app on the use intention, motivation and enjoyment of the app. These are rated on a scale of 1-7, with 1 being the most positive response, 4 being a neutral response and 7 being the most negative response. | Posted | Mean | Standard Deviation | units on a scale | Immediately after the testing |
|
|
|
| Primary | Change in Head Angle With the App | The IMU sensor data collected during the exercise performance with and without the Vestibular Rehabilitation App (collected in the same lab visit on the same group of participants) were analyzed to calculate peak head angles. These were analyzed to identify differences for the conditions with and without the Vestibular Rehabilitation App. | Posted | Mean | Standard Deviation | degrees | During the testing with the app and during the testing without the app (up to 90 minutes) |
|
|
|
|
| Primary | Change in Range of Motion With the App | The IMU sensor data collected during the exercise performance with and without the Vestibular Rehabilitation App (collected in the same lab visit on the same group of participants) were analyzed to calculate head range of motion values. These were analyzed to identify differences for the conditions with and without the Vestibular Rehabilitation App | Posted | Mean | Standard Deviation | degrees | During the testing with the app and during the testing without the app (up to 90 minutes) |
|
|
|
|
| Primary | Change in Head Motion Frequency With the App | The IMU sensor data collected during the exercise performance with and without the Vestibular Rehabilitation App (collected in the same lab visit on the same group of participants) were analyzed to calculate frequency of head motion. These were analyzed to identify differences for the conditions (arms) with and without the Vestibular Rehabilitation App | Posted | Mean | Standard Deviation | Hz | During the testing with the app and during the testing without the app (up to 90 minutes) |
|
|
|
|
| Primary | Change in Balance Outcome With the App - Weight Shift Exercise | The IMU sensor data collected during the exercise performance with and without the Vestibular Rehabilitation App (collected in the same lab visit on the same group of participants) were analyzed to calculate range of motion in different directions during the weight shift balance exercise (in degrees). These were analyzed to identify differences for the conditions with and without the Vestibular Rehabilitation App | Posted | Mean | Standard Deviation | degrees | During the testing with the app and during the testing without the app (up to 90 minutes) |
|
|
|
|
| Primary | Change in Head Angle With Feedback | The IMU sensor data collected during the exercise performance with the Vestibular Rehabilitation App will be analyzed to calculate peak head angles. Averages will be calculated for time windows before and after feedback on exercise performance is given. This will be analyzed to identify differences before and after feedback has been given. | No participants were analyzed because too few participants received feedback during the trials. For participants that did receive feedback the time window before and after the feedback varied widely, since feedback could be provided at any point in time during the trial. Due to these inconsistencies it was decided not to perform any statistically analyses on these data or to extract and analyze these data. | Posted | During the testing with the app (up to 45 minutes) |
|
|
| Primary | Change in Range of Motion With Feedback | The IMU sensor data collected during the exercise performance with the Vestibular Rehabilitation App will be analyzed to calculate range of motion values. Averages will be calculated for time windows before and after feedback on exercise performance is given. This will be analyzed to identify differences before and after feedback has been given. | No data were collected on this. The feedback was mostly provided at the start of the trial and because of this there was no time window before the feedback, which would be required to calculate the change. | Posted | During the intervention with the app (up to 45 minutes) |
|
|
| Primary | Change in Angular Velocity With Feedback | The IMU sensor data collected during the exercise performance with the Vestibular Rehabilitation App will be analyzed to calculate angular velocity values . Averages will be calculated for time windows before and after feedback on exercise performance is given. This will be analyzed to identify differences before and after feedback has been given. | No data were collected on this. The feedback was mostly provided at the start of the trial and because of this there was no time window before the feedback, which would be required to calculate the change. | Posted | During the intervention with the app (up to 45 minutes) |
|
|
| Primary | Change in Balance Outcome With Feedback | The IMU sensor data collected during the exercise performance with the Vestibular Rehabilitation App will be analyzed to calculate balance measures (jerk). Averages will be calculated for time windows before and after feedback on exercise performance is given. This will be analyzed to identify differences before and after feedback has been given. | No data were collected on this. The feedback was mostly provided at the start of the trial and because of this there was no time window before the feedback, which would be required to calculate the change. | Posted | During the intervention with the app (up to 45 minutes) |
|
|
| Primary | Error Identification Differences | The exercise errors that are identified by the Vestibular Rehabilitation App and those identified by the physical therapist will be compared. | No data were collected on this. The feedback was mostly provided at the start of the trial and because of this there was no time window before the feedback, which would be required to calculate the change. | Posted | During the intervention with the app (up to 45 minutes) |
|
|
| Secondary | Open Ended Feedback | Participants will be asked for open ended feedback after the testing with and without the Vestibular Rehabilitation App. Discussions will be guided with questions. The questions were as follows: 1) Describe your overall experience as you used the app today?; 2) Explain the positive features of the app as you did your exercises?; 3) Describe the negative features of the app as you did your exercises today?; 4) What changes would you like to see in the app to support you as you do your exercises?; 5) Do you see any barriers to using the app while doing your exercises at home? | The open ended questions referred to the use of the Vestibular Rehabilitation App and were therefore only filled out with regards to the arm "Trials with the Vestibular Rehabilitation App" | Posted | Count of Participants | Participants | No | Immediately after the intervention |
|
|
|
| Primary | Change in Balance Outcome With the App - Single Leg Balance | The IMU sensor data collected during the exercise performance with and without the Vestibular Rehabilitation App (collected in the same lab visit on the same group of participants) were analyzed to calculate balance measure fluency (a non-dimensional derivative of jerk). This was analyzed to identify differences for the conditions with and without the Vestibular Rehabilitation App | Posted | Mean | Standard Deviation | degrees | During the testing with the app and during the testing without the app (up to 90 minutes) |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Peak yaw angle - flexion |
|
| Peak yaw angle - extension |
|
This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test
| paired t-test |
| <0.001 |
Difference in head angle pitch - right between the arms |
| Other |
| This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test | paired t-test | 0.042 | Difference in head angle yaw - extension between the arms | Other |
| This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test | paired t-test | 0.111 | Difference in head angle yaw - flexion between the arms | Other |
This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test
| paired t-test |
| <0.001 |
| Other |
| paired t-test |
| 0.003 |
Difference in yaw velocity between the arms |
| Other |
| Single leg balance - range of motion |
|
Weight shift balance exercise anteroposterior range of motion |
| Other |
| paired t-test | 0.024 | Single leg balance range of motion | Other |
| Shapiro Wilcoxon test | Data was not normally distributed. | 0.257 | Single leg balance fluency | Other |
| Overall experience - easy or easy to understand |
|
| Overall experience - engaging or interesting |
|
| Overall experience - motivating |
|
| Overall experience - difficult |
|
| Overall experience - seems geared toward more younger adults |
|
| Overall experience - not motivating |
|
| Overall experience - challenging (in a positive way) |
|
| Overall experience - reduced anxiety |
|
| Positive features - fun |
|
| Positive features - motivating |
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| Positive features - provides feedback |
|
| Positive features - challenging |
|
| Positive features - colorful |
|
| Positive features - easy to use |
|
| Positive features - helpful |
|
| Positive feedback - seeing progress or accomplishments |
|
| Positive feedback - liked scoring or rewards |
|
| Positive feedback - liked the gaming element |
|
| Negative features - none noted |
|
| Negative features - feedback interrupted flow |
|
| Negative feedback - redundant instructions |
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| Negative feedback - frustration with motion control |
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| Negative feedback - learning curve |
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| Negative feedback - transition from weight shifting to balance games was challenging |
|
| Negative feedback - juvenile theme |
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| Negative feedback - longer setup than traditional therapy |
|
| Negative feedback - may get boring after a while |
|
| Negative feedback - colors may be hard with color blindness in some games |
|
| Would like - motion sensing improvement |
|
| Would like - larger screen or font |
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| Would like - more rewards |
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| Would like - phone version |
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| Would like - wider variety of games |
|
| Would like - nothing, good as is |
|
| Would like - sound effects |
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| Would like - different theme |
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| Would like - color blind accessibility |
|
| Would like - demo video / real human demonstration |
|
| Would like - personalization |
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| Would like - multi-player version |
|
| Barriers - none |
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| Barriers - may be hard for older population to get used to technology |
|
| Barriers - Setup at home and safety |
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| Barriers - learning how to use the app |
|
| Barriers - equipment (tablet and stand) and equipment setup |
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| Barriers - cell phone version would be needed |
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| Barriers - cost |
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| Barriers - needing family members to help with setup |
|
| Barriers - adherence to exercises |
|