ClinicalTrials.gg
CompletedNCT05022589rSTANDUpdated Jun 10, 2026Results posted

Remote Digital Health Intervention to Improve Balance and Reduce Fall Risk

An interventional study of Computerized Plasticity-Based Adaptive Cognitive Training in Fall, sponsored by Posit Science Corporation. Completed at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-06-10.

Sponsored by Posit Science Corporation · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Not applicable
Ages
65 Years and older
Sex
All
01

Study summary

The goal of this project is to further develop and evaluate a computerized cognitive-training program designed to extend older adults' functional independence and reduce accidental falls (i.e., reduce factors that contribute to fall risk; including cognitive abilities/executive functions). This intervention may benefit a large population of vulnerable older adults with elevated fall risk and lack of long-term viable treatment options.

Read the detailed description

The investigators will employ a single arm study open label usability/feasibility study comprised of a computerized training program that targets core executive functions (working memory, inhibition), speed of processing and sustained attention, and is grounded on design principles that drive adaptive brain plasticity to improve cognitive function and bolster functional abilities in older adults with an elevated fall risk.

02

Conditions studied

  • Fall
03

In context

Lead sponsor

Posit Science Corporation is the lead sponsor of 36 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Participants who are 65 years of age or older.
  2. Participants must be US residents.
  3. Participant with at least one self-reported fall within the last 1 year or difficulty walking one half a mile or difficulty climbing one flight of stairs.
  4. Participants who are fluent English speakers from the age of 12, per self-report, to ensure reasonable neuropsychological results on key assessments.
  5. Participant must have adequate sensorimotor capacity to perform the program, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control a computer mouse or a tablet.

Exclusion criteria

Exclusion Criteria:

  1. Participants had joint replacement surgery or significant join/leg injury less than one year prior to the screening visit.
  2. Participants have a joint replacement surgery scheduled within the next 6 months.
  3. Participants use a walker or wheelchair on a regular basis.
  4. Participants have a diagnosis of benign paroxysmal positional vertigo (BPPV), labyrinthitis or suffers migraines that result in chronic vertigo.
  5. Participants self-reports vision or hearing difficulties that would interfere with the ability to complete the study tasks.
  6. Participants with untreated psychiatric conditions, including substance abuse/dependence disorders, recent hospitalization, ongoing chemotherapy or other cancer treatment.
  7. Participants with medical illnesses, injuries or conditions predisposing to imminent functional and/or cognitive decline (e.g. multiple sclerosis, stroke, traumatic brain injury, dementia, etc.)
  8. Participants enrolled in a concurrent clinical trial involving an intervention targeting physical functioning to prevent falls; pharmaceutical; nutraceutical; medical device; or behavioral treatment that could affect the outcome of this study. However, participation in standard treatments (e.g., occupational therapy) or use of prescribed medications (e.g., anti-depressants) is allowable.
  9. Participants using computer-based cognitive training programs or has used it within a month of the consent date.
  10. Participants who answered 'yes' to questions 4 (Active Suicidal Ideation with Intent) or 5 (Active Suicidal Ideation with Specific Plan and Intent) on the Columbia-Suicide Severity Rating Scale (C-SSRS) or 'yes' to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act or behavior) on the C-SSRS "Suicidal Behavior" if the ideation or behavior occurred within 2 months from Participant's date of consent.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Experimental Treatment

    Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, \~30 minutes per session.

    Other: Computerized Plasticity-Based Adaptive Cognitive Training

Interventions

  • OtherComputerized 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.

    Also known as: rSTAND

06

What researchers measure

Primary outcomes

  1. Net Promoter Score (NPS)

    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.

    Time frame: At 10 weeks

Secondary outcomes

  1. Program Adoption Rate

    Evaluating the adoption of the intervention program.

    Time frame: 10 weeks

  2. Usability - Program Navigation - Platform is Accessible and Easy to Navigate

    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.

    Time frame: 10 weeks

  3. Usability - Perceived Benefits - Felt Program Was Therapeutic

    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.

    Time frame: 10 weeks

  4. Usability - Whether the Program Helped Participants Make a Positive Change in Their Activities of Daily Living

    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.

    Time frame: 10 weeks

  5. Program Training Levels Completed

    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.

    Time frame: 10 weeks

  6. The Activities-specific Balance Confidence (ABC) Scale

    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.

    Time frame: 10 weeks

  7. Activity Measure for Post-Acute Care (AM-PAC)

    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.

    Time frame: 10 weeks

  8. Brief Pain Inventory (BPI) - Pain Severity Subscale

    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.

    Time frame: 10 weeks

  9. Falls Calendar - Self-reported Falls

    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.

    Time frame: 10 weeks

  10. Falls Calendar - Self-reported Loss of Balance

    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.

    Time frame: 10 weeks

  11. Falls Detection

    A spontaneous fall detection utility embedded in the Apple watch.

    Time frame: 10 weeks

  12. Gait Speed Score

    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.

    Time frame: 10 weeks

07

Results

Posted Jun 10, 2026

Participant flow

Participant flow — Overall Study
MilestoneExperimental Treatment
Started32
Completed baseline26
Started intervention24
Completed23
Not completed9
Withdrew: Withdrawal by subject8
Withdrew: Lost to follow-up1

Outcome measures

PrimaryNet Promoter Score (NPS)

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.

Time frame:
At 10 weeks
Reported as:
Mean · score on a scale
Net Promoter Score (NPS)
score on a scaleExperimental Treatment
Net Promoter Score (NPS)82.61 (63 to 100)
SecondaryProgram Adoption Rate

Evaluating the adoption of the intervention program.

Time frame:
10 weeks
Reported as:
Number · participants
Program Adoption Rate
participantsExperimental Treatment
Program Adoption Rate23
SecondaryUsability - Program Navigation - Platform is Accessible and Easy to Navigate

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.

Time frame:
10 weeks
Reported as:
Mean · score on a scale
Usability - Program Navigation - Platform is Accessible and Easy to Navigate
score on a scaleExperimental Treatment
Usability - Program Navigation - Platform is Accessible and Easy to Navigate6.3 ± 0.48
SecondaryUsability - Perceived Benefits - Felt Program Was Therapeutic

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.

Time frame:
10 weeks
Reported as:
Mean · score on a scale
Usability - Perceived Benefits - Felt Program Was Therapeutic
score on a scaleExperimental Treatment
Usability - Perceived Benefits - Felt Program Was Therapeutic6.0 ± 0.51
SecondaryUsability - Whether the Program Helped Participants Make a Positive Change in Their Activities of Daily Living

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.

Time frame:
10 weeks
Reported as:
Mean · score on a scale
Usability - Whether the Program Helped Participants Make a Positive Change in Their Activities of Daily Living
score on a scaleExperimental Treatment
Usability - Whether the Program Helped Participants Make a Positive Change in Their Activities of Daily Living6.0 ± 0.50
SecondaryProgram Training Levels Completed

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.

Time frame:
10 weeks
Reported as:
Mean · score on a scale
Program Training Levels Completed
score on a scaleExperimental Treatment
Program Training Levels Completed526 ± 68
SecondaryThe Activities-specific Balance Confidence (ABC) Scale

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.

Time frame:
10 weeks
Reported as:
Mean · score on a scale
The Activities-specific Balance Confidence (ABC) Scale
score on a scaleExperimental Treatment
Baseline81.77 ± 14.23
10 weeks87.19 ± 10.77
SecondaryActivity Measure for Post-Acute Care (AM-PAC)

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.

Time frame:
10 weeks
Reported as:
Mean · score on a scale
Activity Measure for Post-Acute Care (AM-PAC)
score on a scaleExperimental Treatment
Baseline62.08 ± 5.06
10 weeks64.30 ± 6.56
SecondaryBrief Pain Inventory (BPI) - Pain Severity Subscale

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.

Time frame:
10 weeks
Reported as:
Mean · score on a scale
Brief Pain Inventory (BPI) - Pain Severity Subscale
score on a scaleExperimental Treatment
Baseline1.60 ± 1.52
10 weeks1.52 ± 1.62
SecondaryFalls Calendar - Self-reported Falls

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.

Time frame:
10 weeks
Reported as:
Number · number of falls
Falls Calendar - Self-reported Falls
number of fallsExperimental Treatment
Falls Calendar - Self-reported Falls4
SecondaryFalls Calendar - Self-reported Loss of Balance

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.

Time frame:
10 weeks
Reported as:
Number · instances
Falls Calendar - Self-reported Loss of Balance
instancesExperimental Treatment
Falls Calendar - Self-reported Loss of Balance58
SecondaryFalls Detection

A spontaneous fall detection utility embedded in the Apple watch.

Time frame:
10 weeks
Reported as:
Number · number of falls detected
Falls Detection
number of falls detectedExperimental Treatment
Falls Detection0
SecondaryGait Speed Score

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.

Time frame:
10 weeks
Reported as:
Mean · seconds
Gait Speed Score
secondsExperimental Treatment
Baseline1.28 ± 0.18
10 weeks1.22 ± 0.15

Adverse events

Collected over 10 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Experimental Treatment0/23 (0%)0/23 (0%)0/23 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Experimental Treatment
<=18 years0
Between 18 and 65 years0
>=65 years23
Sex: Female, Male
Sex: Female, Male(Participants)Experimental Treatment
Female19
Male4
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Experimental Treatment
American Indian or Alaska Native0
Asian3
Native Hawaiian or Other Pacific Islander0
Black or African American0
White20
More than one race0
Unknown or Not Reported0
08

Study locations

1 site
  • Posit Science Corporation
    San Francisco, California 94111, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2022 to primary completion in Apr 2024, 20 months.

Results were first posted in Jun 2026, 2 years 1 month after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 20, 2021
First posted
Aug 26, 2021
StartActual
Aug 9, 2022
Primary completionActual
Apr 19, 2024
CompletionActual
Apr 19, 2024
Results first posted
Jun 10, 2026
Last update
Jun 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05022589
Responsible party
Sponsor
First posted
Aug 26, 2021
Start date
Aug 9, 2022
Primary completion
Apr 19, 2024
Completion
Apr 19, 2024
Results posted
Jun 10, 2026
Last update
Jun 10, 2026

Study contacts

Thomas Van Vleet, PhD
principal investigator · Posit Science Corporation

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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