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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

32 participants

Primary outcome timeframe

At 10 weeks

Results posted on

2026-06-10

Participant Flow

Participant milestones

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.
Overall Study
STARTED
32
Overall Study
Completed Baseline
26
Overall Study
Started Intervention
24
Overall Study
COMPLETED
23
Overall Study
NOT COMPLETED
9

Reasons for withdrawal

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.
Overall Study
Withdrawal by Subject
8
Overall Study
Lost to Follow-up
1

Baseline Characteristics

Remote Digital Health Intervention to Improve Balance and Reduce Fall Risk

Baseline characteristics by cohort

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.
Age, Categorical
<=18 years
0 Participants
n=9 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=9 Participants
Age, Categorical
>=65 years
23 Participants
n=9 Participants
Sex: Female, Male
Female
19 Participants
n=9 Participants
Sex: Female, Male
Male
4 Participants
n=9 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=9 Participants
Race (NIH/OMB)
Asian
3 Participants
n=9 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=9 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=9 Participants
Race (NIH/OMB)
White
20 Participants
n=9 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=9 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=9 Participants

PRIMARY outcome

Timeframe: At 10 weeks

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.

Outcome measures

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.
Net Promoter Score (NPS)
82.61 score on a scale
Interval 63.0 to 100.0

SECONDARY outcome

Timeframe: 10 weeks

Population: One participant could not commit to the amount of time required to use the program.

Evaluating the adoption of the intervention program.

Outcome measures

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.
Program Adoption Rate
23 participants

SECONDARY outcome

Timeframe: 10 weeks

This 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

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.
Usability - Program Navigation - Platform is Accessible and Easy to Navigate
6.3 score on a scale
Standard Deviation 0.48

SECONDARY outcome

Timeframe: 10 weeks

This 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

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.
Usability - Perceived Benefits - Felt Program Was Therapeutic
6.0 score on a scale
Standard Deviation 0.51

SECONDARY outcome

Timeframe: 10 weeks

This 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

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.
Usability - Whether the Program Helped Participants Make a Positive Change in Their Activities of Daily Living
6.0 score on a scale
Standard Deviation 0.50

SECONDARY outcome

Timeframe: 10 weeks

Engagement 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

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.
Program Training Levels Completed
526 score on a scale
Standard Deviation 68

SECONDARY outcome

Timeframe: 10 weeks

This 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

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.
The Activities-specific Balance Confidence (ABC) Scale
Baseline
81.77 score on a scale
Standard Deviation 14.23
The Activities-specific Balance Confidence (ABC) Scale
10 weeks
87.19 score on a scale
Standard Deviation 10.77

SECONDARY outcome

Timeframe: 10 weeks

This 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

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.
Activity Measure for Post-Acute Care (AM-PAC)
Baseline
62.08 score on a scale
Standard Deviation 5.06
Activity Measure for Post-Acute Care (AM-PAC)
10 weeks
64.30 score on a scale
Standard Deviation 6.56

SECONDARY outcome

Timeframe: 10 weeks

This 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

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.
Brief Pain Inventory (BPI) - Pain Severity Subscale
Baseline
1.60 score on a scale
Standard Deviation 1.52
Brief Pain Inventory (BPI) - Pain Severity Subscale
10 weeks
1.52 score on a scale
Standard Deviation 1.62

SECONDARY outcome

Timeframe: 10 weeks

Total 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

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.
Falls Calendar - Self-reported Falls
4 number of falls

SECONDARY outcome

Timeframe: 10 weeks

Total 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

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.
Falls Calendar - Self-reported Loss of Balance
58 instances

SECONDARY outcome

Timeframe: 10 weeks

A spontaneous fall detection utility embedded in the Apple watch.

Outcome measures

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.
Falls Detection
0 number of falls detected

SECONDARY outcome

Timeframe: 10 weeks

Gait 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

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.
Gait Speed Score
Baseline
1.28 seconds
Standard Deviation 0.18
Gait Speed Score
10 weeks
1.22 seconds
Standard Deviation 0.15

Adverse Events

Experimental Treatment

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Tom Van Vleet

Posit Science Corporation

Phone: (415) 568-3562

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place