FallrSTANDNCT05022589
Remote Digital Health Intervention to Improve Balance and Reduce Fall Risk
A study testing Computerized Plasticity-Based Adaptive Cognitive Training in people with Fall, run by Posit Science Corporation at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Fall
- What is being tested?
- Computerized Plasticity-Based Adaptive Cognitive Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2022to 19 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Participants who are 65 years of age or older.
- Participants must be US residents.
- 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.
- Participants who are fluent English speakers from the age of 12, per self-report, to ensure reasonable neuropsychological results on key assessments.
- 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.
Who cannot join
- Participants had joint replacement surgery or significant join/leg injury less than one year prior to the screening visit.
- Participants have a joint replacement surgery scheduled within the next 6 months.
- Participants use a walker or wheelchair on a regular basis.
- Participants have a diagnosis of benign paroxysmal positional vertigo (BPPV), labyrinthitis or suffers migraines that result in chronic vertigo.
- Participants self-reports vision or hearing difficulties that would interfere with the ability to complete the study tasks.
- Participants with untreated psychiatric conditions, including substance abuse/dependence disorders, recent hospitalization, ongoing chemotherapy or other cancer treatment.
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- 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.)
- Participants enrolled in a concurrent clinical trial involving an intervention targeting physical functioning to prevent falls; investigational 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.
- Participants using computer-based cognitive training programs or has used it within a month of the consent date.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Posit Science Corporation
San Francisco, California, 94111
About this study
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.
- Conditions
- Fall
- Being tested
- Computerized Plasticity-Based Adaptive Cognitive Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Plasticity-Based Adaptive Cognitive TrainingOther
Also called rSTAND
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, ~30 minutes per session.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Treatment | Experimental | Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, ~30 minutes per session. Receives: Other: Computerized Plasticity-Based Adaptive Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 10 weeks
Secondary outcomes (12)
Program Adoption Rate
Evaluating the adoption of the intervention program.
Measured: 10 weeks
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.
Measured: 10 weeks
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.
Measured: 10 weeks
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.
Measured: 10 weeks
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.
Measured: 10 weeks
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.
Measured: 10 weeks
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.
Measured: 10 weeks
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.
Measured: 10 weeks
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.
Measured: 10 weeks
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.
Measured: 10 weeks
Falls Detection
A spontaneous fall detection utility embedded in the Apple watch.
Measured: 10 weeks
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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start9 Aug 2022
- Primary completion19 Apr 2024
- Study completion19 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FallStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Posit Science Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Thomas Van Vleet, PhD, Principal investigator, Posit Science Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022589
- Sponsor's protocol ID
- PSC-0820-21
- Other IDs
- 5R44AG076304
- Acronym
- rSTAND
- Status last verified
- Jun 2026
- First submitted
- 20 Aug 2021
- Last updated
- 10 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Digital Health Intervention to Improve Balance and Reduce Fall Risk
- ClinicalTrials.gov ID
- NCT05022589
- Acronym / sponsor ID
- rSTAND / PSC-0820-21
- Conditions
- Fall
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Posit Science CorporationIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 9 Aug 2022 (actual)
- Primary completion
- 19 Apr 2024 (actual)
- Study completion
- 19 Apr 2024 (actual)
- First posted
- 26 Aug 2021 (actual)
- Results
- Posted 10 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Treatment | Experimental | Other: Computerized Plasticity-Based Adaptive Cognitive TrainingComputerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, ~30 minutes per session. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Participants who are 65 years of age or older.
- Participants must be US residents.
- 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.
- Participants who are fluent English speakers from the age of 12, per self-report, to ensure reasonable neuropsychological results on key assessments.
- 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.
Key exclusion criteria (10 listed)
- Participants had joint replacement surgery or significant join/leg injury less than one year prior to the screening visit.
- Participants have a joint replacement surgery scheduled within the next 6 months.
- Participants use a walker or wheelchair on a regular basis.
- Participants have a diagnosis of benign paroxysmal positional vertigo (BPPV), labyrinthitis or suffers migraines that result in chronic vertigo.
- Participants self-reports vision or hearing difficulties that would interfere with the ability to complete the study tasks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized Plasticity-Based Adaptive Cognitive TrainingAlso: rSTANDComputerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, ~30 minutes per session. | Other | Experimental Treatment |
Primary outcome
Net Promoter Score (NPS)
Time frame: 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.
12 secondary outcomes
Program Adoption Rate
Time frame: 10 weeks
Usability - Program Navigation - Platform is Accessible and Easy to Navigate
Time frame: 10 weeks
Usability - Perceived Benefits - Felt Program Was Therapeutic
Time frame: 10 weeks
Usability - Whether the Program Helped Participants Make a Positive Change in Their Activities of Daily Living
Time frame: 10 weeks
Program Training Levels Completed
Time frame: 10 weeks
The Activities-specific Balance Confidence (ABC) Scale
Time frame: 10 weeks
Activity Measure for Post-Acute Care (AM-PAC)
Time frame: 10 weeks
Brief Pain Inventory (BPI) - Pain Severity Subscale
Time frame: 10 weeks
Falls Calendar - Self-reported Falls
Time frame: 10 weeks
Falls Calendar - Self-reported Loss of Balance
Time frame: 10 weeks
Falls Detection
Time frame: 10 weeks
Gait Speed Score
Time frame: 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Van Vleet, PhD principal investigator
Posit Science Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Plasticity-Based Adaptive Cognitive Training in people with Fall, run by Posit Science Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Net Promoter Score (NPS) (time frame: At 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.