A Digital Balance Program With Comparison Group

NCT06868680 | Completed

• 1 other identifier: 20240129
• Study Type: interventional
• Target: 687
• Locations: 1 country
• Sites: 1

Brief Summary

This research study evaluates a digital musculoskeletal care program specifically focused on balance improvement and falls prevention. The primary goal is to determine if the program results in fewer falls compared to a comparison condition where people will get educational/information articles on falls prevention. Study participants are asked to participate in their assigned condition and complete surveys throughout the study.

Conditions

Falls

Keywords

balance; falls prevention; older adults; exercise therapy; telerehabilitation

Outcome Measures

Primary Outcomes (1)

• Annualized fall rate

  Annualized fall rate was calculated at baseline as the total number of falls experienced within the past year, divided by 12. Annualized fall rate was calculated at month three as the total number of falls participants reported experiencing between baseline and month three, divided by 0.25 person-years

  3 months

Secondary Outcomes (1)

• Fall Severity

  baseline to 3 months

Study Arms (2)

Balance Program

EXPERIMENTAL

A digital program of exercise therapy, access to physical therapist and health coach, and educational articles on falls prevention.

Behavioral: Balance Program

Comparison Group

ACTIVE COMPARATOR

Shared educational content on falls prevention and the importance of balance.

Other: Educational Reading Content

Interventions

Balance Program BEHAVIORAL

A comprehensive program of tailored exercise therapy, educational content spanning a variety of topics related to balance improvement and fall prevention, a personalized clinical approach to improving balance, and access to a board-certified health coach and physical therapist.

Balance Program

Educational Reading Content OTHER

Informational articles on reducing risk for falls.

Comparison Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• had an email account and owned a smartphone
• had a moderate-high fall risk based on the Stopping Elderly Accidents, Deaths, and Injuries (STEADI) questionnaire (≥ 4 points)

You may not qualify if:

• undergone musculoskeletal surgery within three months prior to recruitment
• a history of opioid, alcohol, or drug abuse within the last year
• a diagnosis of cognitive, behavioral, neurologic, or psychiatric disorders
• any contraindication for light physical activity as directed by the prospective participant's doctor

Sponsors & Collaborators

• Hinge Health, Inc: lead

Study Sites (1)

Hinge Health

San Francisco, California, 94105, United States

Location

Study Officials

• Cynthia M Castro Sweet, PhD

  Hinge Health, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 11, 2025
• Study Start: February 16, 2024
• Primary Completion: July 23, 2024
• Study Completion: November 1, 2024
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

US (1)