Remote Digital Health Intervention to Improve Balance and Reduce Fall Risk

Completed · Not applicable

Conditions studied: Fall

In brief

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.

Key facts

Study ID

NCT05022589

Run by

Posit Science Corporation

People needed

32

Starts

2022-08-09

Expected to finish

2024-04-19

Last updated by the study team

2026-06-10

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• Posit Science Corporation — San Francisco, California, United States

Full record on ClinicalTrials.gov

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