Trial Outcomes & Findings for Remote Digital Health Intervention to Improve Balance and Reduce Fall Risk (NCT NCT05022589)
NCT ID: NCT05022589
Last Updated: 2026-06-10
Results Overview
NPS (Net Promoter Score) is a whole number on a scale of -100 to +100, calculated by subtracting the percentage of Detractors from the percentage of Promoters. Promoters (score 9-10) are likely to exhibit value-creating behaviors, such as referring other potential program participants. Detractors (score 0-6) are less likely to do so. Passives (score 7-8) fall in between. Passives count toward the total number of respondents, which decreases the percentage of Promoters and Detractors and pushes the score toward 0. Higher score is better.
COMPLETED
NA
32 participants
At 10 weeks
2026-06-10
Participant Flow
Participant milestones
| Measure |
Experimental Treatment
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, \~30 minutes per session.
Computerized Plasticity-Based Adaptive Cognitive Training: Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, \~30 minutes per session.
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|---|---|
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Overall Study
STARTED
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32
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Overall Study
Completed Baseline
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26
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Overall Study
Started Intervention
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24
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Overall Study
COMPLETED
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23
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Overall Study
NOT COMPLETED
|
9
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Reasons for withdrawal
| Measure |
Experimental Treatment
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, \~30 minutes per session.
Computerized Plasticity-Based Adaptive Cognitive Training: Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, \~30 minutes per session.
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|---|---|
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Overall Study
Withdrawal by Subject
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8
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Overall Study
Lost to Follow-up
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1
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Baseline Characteristics
Remote Digital Health Intervention to Improve Balance and Reduce Fall Risk
Baseline characteristics by cohort
| Measure |
Experimental Treatment
n=23 Participants
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, \~30 minutes per session.
Computerized Plasticity-Based Adaptive Cognitive Training: Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, \~30 minutes per session.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=9 Participants
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Age, Categorical
Between 18 and 65 years
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0 Participants
n=9 Participants
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Age, Categorical
>=65 years
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23 Participants
n=9 Participants
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Sex: Female, Male
Female
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19 Participants
n=9 Participants
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Sex: Female, Male
Male
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4 Participants
n=9 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=9 Participants
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Race (NIH/OMB)
Asian
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3 Participants
n=9 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=9 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=9 Participants
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Race (NIH/OMB)
White
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20 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=9 Participants
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PRIMARY outcome
Timeframe: At 10 weeksNPS (Net Promoter Score) is a whole number on a scale of -100 to +100, calculated by subtracting the percentage of Detractors from the percentage of Promoters. Promoters (score 9-10) are likely to exhibit value-creating behaviors, such as referring other potential program participants. Detractors (score 0-6) are less likely to do so. Passives (score 7-8) fall in between. Passives count toward the total number of respondents, which decreases the percentage of Promoters and Detractors and pushes the score toward 0. Higher score is better.
Outcome measures
| Measure |
Experimental Treatment
n=23 Participants
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, \~30 minutes per session.
Computerized Plasticity-Based Adaptive Cognitive Training: Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, \~30 minutes per session.
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|---|---|
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Net Promoter Score (NPS)
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82.61 score on a scale
Interval 63.0 to 100.0
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SECONDARY outcome
Timeframe: 10 weeksPopulation: One participant could not commit to the amount of time required to use the program.
Evaluating the adoption of the intervention program.
Outcome measures
| Measure |
Experimental Treatment
n=24 Participants
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, \~30 minutes per session.
Computerized Plasticity-Based Adaptive Cognitive Training: Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, \~30 minutes per session.
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|---|---|
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Program Adoption Rate
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23 participants
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SECONDARY outcome
Timeframe: 10 weeksThis is a brief and embedded post-study questionnaire on program navigation, perceived benefits, and whether the program helped participants to make a positive change in their activities of daily living. Participants rate each sentence on the following 7-point Likert scale: 1 =Completely Disagree; 2 = Mostly Disagree; 3 = Somewhat Disagree; 4 = Undecided; 5 = Somewhat Agree; 6 = Mostly Agree; 7 = Completely Agree. Scoring range: 1-7; higher score is better.
Outcome measures
| Measure |
Experimental Treatment
n=23 Participants
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, \~30 minutes per session.
Computerized Plasticity-Based Adaptive Cognitive Training: Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, \~30 minutes per session.
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|---|---|
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Usability - Program Navigation - Platform is Accessible and Easy to Navigate
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6.3 score on a scale
Standard Deviation 0.48
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SECONDARY outcome
Timeframe: 10 weeksThis is a brief and embedded post-study questionnaire on program navigation, perceived benefits, and whether the program helped participants to make a positive change in their activities of daily living. Participants rate each sentence on the following 7-point Likert scale: 1 =Completely Disagree; 2 = Mostly Disagree; 3 = Somewhat Disagree; 4 = Undecided; 5 = Somewhat Agree; 6 = Mostly Agree; 7 = Completely Agree. Scoring range: 1-7; higher score is better.
Outcome measures
| Measure |
Experimental Treatment
n=23 Participants
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, \~30 minutes per session.
Computerized Plasticity-Based Adaptive Cognitive Training: Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, \~30 minutes per session.
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|---|---|
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Usability - Perceived Benefits - Felt Program Was Therapeutic
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6.0 score on a scale
Standard Deviation 0.51
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SECONDARY outcome
Timeframe: 10 weeksThis is a brief and embedded post-study questionnaire on program navigation, perceived benefits, and whether the program helped participants to make a positive change in their activities of daily living. Participants rate each sentence on the following 7-point Likert scale: 1 =Completely Disagree; 2 = Mostly Disagree; 3 = Somewhat Disagree; 4 = Undecided; 5 = Somewhat Agree; 6 = Mostly Agree; 7 = Completely Agree. Scoring range: 1-7; higher score is better.
Outcome measures
| Measure |
Experimental Treatment
n=23 Participants
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, \~30 minutes per session.
Computerized Plasticity-Based Adaptive Cognitive Training: Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, \~30 minutes per session.
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|---|---|
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Usability - Whether the Program Helped Participants Make a Positive Change in Their Activities of Daily Living
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6.0 score on a scale
Standard Deviation 0.50
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SECONDARY outcome
Timeframe: 10 weeksEngagement with the program was evaluated based on the total number of training levels completed. Intended Range: 0-500 levels. Actual range: 441-777 levels. Higher number is better.
Outcome measures
| Measure |
Experimental Treatment
n=23 Participants
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, \~30 minutes per session.
Computerized Plasticity-Based Adaptive Cognitive Training: Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, \~30 minutes per session.
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|---|---|
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Program Training Levels Completed
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526 score on a scale
Standard Deviation 68
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SECONDARY outcome
Timeframe: 10 weeksThis is a 16-item self-report questionnaire to assess confidence in performing various activities without losing balance or experiencing a sense of unsteadiness. Scoring range is 0% to 100% confidence scale where a score of 0% means no confidence while 100% indicates complete confidence. Higher score is better.
Outcome measures
| Measure |
Experimental Treatment
n=23 Participants
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, \~30 minutes per session.
Computerized Plasticity-Based Adaptive Cognitive Training: Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, \~30 minutes per session.
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|---|---|
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The Activities-specific Balance Confidence (ABC) Scale
Baseline
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81.77 score on a scale
Standard Deviation 14.23
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The Activities-specific Balance Confidence (ABC) Scale
10 weeks
|
87.19 score on a scale
Standard Deviation 10.77
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SECONDARY outcome
Timeframe: 10 weeksThis scale is an 18-item validated patient-reported outcome measure designed to assess functional abilities across multiple domains, including basic mobility, daily activities, and applied cognitive functioning. The AM-PAC uses a T-score metric, standardized with a mean of 50 and a standard deviation of 10, to reflect mobility function. Higher T-scores reflect better mobility.
Outcome measures
| Measure |
Experimental Treatment
n=23 Participants
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, \~30 minutes per session.
Computerized Plasticity-Based Adaptive Cognitive Training: Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, \~30 minutes per session.
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|---|---|
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Activity Measure for Post-Acute Care (AM-PAC)
Baseline
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62.08 score on a scale
Standard Deviation 5.06
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Activity Measure for Post-Acute Care (AM-PAC)
10 weeks
|
64.30 score on a scale
Standard Deviation 6.56
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SECONDARY outcome
Timeframe: 10 weeksThis is an 11-item self-report questionnaire assessing current pain intensity and the degree to which pain interferes with daily life. The Pain Severity Subscale contains 4 items; scores are summed and divided by 4, yielding a range of 0 (No pain) to 10 (Pain as bad as you can imagine). Higher scores indicate greater severity.
Outcome measures
| Measure |
Experimental Treatment
n=23 Participants
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, \~30 minutes per session.
Computerized Plasticity-Based Adaptive Cognitive Training: Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, \~30 minutes per session.
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|---|---|
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Brief Pain Inventory (BPI) - Pain Severity Subscale
Baseline
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1.60 score on a scale
Standard Deviation 1.52
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Brief Pain Inventory (BPI) - Pain Severity Subscale
10 weeks
|
1.52 score on a scale
Standard Deviation 1.62
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SECONDARY outcome
Timeframe: 10 weeksTotal number of self-reported falls. A falls calendar questionnaire was administered weekly to inquire about recent falls and/or if the participant had tripped or lost balance without falling each week during the study. Lower number is better; indicating fewer falls reported.
Outcome measures
| Measure |
Experimental Treatment
n=23 Participants
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, \~30 minutes per session.
Computerized Plasticity-Based Adaptive Cognitive Training: Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, \~30 minutes per session.
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|---|---|
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Falls Calendar - Self-reported Falls
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4 number of falls
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SECONDARY outcome
Timeframe: 10 weeksTotal number of self-reported loss of balance/trips. A falls calendar questionnaire was administered weekly to inquire about recent falls and/or if the participant had tripped or lost balance without falling each week during the study. Lower number is better; indicating fewer instances of loss of balance/trips.
Outcome measures
| Measure |
Experimental Treatment
n=23 Participants
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, \~30 minutes per session.
Computerized Plasticity-Based Adaptive Cognitive Training: Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, \~30 minutes per session.
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|---|---|
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Falls Calendar - Self-reported Loss of Balance
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58 instances
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SECONDARY outcome
Timeframe: 10 weeksA spontaneous fall detection utility embedded in the Apple watch.
Outcome measures
| Measure |
Experimental Treatment
n=23 Participants
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, \~30 minutes per session.
Computerized Plasticity-Based Adaptive Cognitive Training: Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, \~30 minutes per session.
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|---|---|
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Falls Detection
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0 number of falls detected
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SECONDARY outcome
Timeframe: 10 weeksGait speed is measured through a self-administered, telehealth coach-supported 60-second Gait App test at baseline and after program use. This assessment requires an iPhone or iPod Touch. The metric captures the time (in seconds) elapsed between the first contact of two consecutive footsteps of the same foot. A lower score reflects faster gait speed, which indicates better performance.
Outcome measures
| Measure |
Experimental Treatment
n=23 Participants
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, \~30 minutes per session.
Computerized Plasticity-Based Adaptive Cognitive Training: Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, \~30 minutes per session.
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|---|---|
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Gait Speed Score
Baseline
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1.28 seconds
Standard Deviation 0.18
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Gait Speed Score
10 weeks
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1.22 seconds
Standard Deviation 0.15
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Adverse Events
Experimental Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place