A Digital Balance Program With Comparison Group

Prospective, Balance Program Study With Comparison Group

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.

Study Overview

• Status: Completed
• Conditions: Falls
• Intervention / Treatment: Behavioral: Balance Program; Other: Educational Reading Content

Detailed Description

The digital Balance Program is accessible through a smartphone or tablet and includes 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. The comparison group consists of a series of emailed articles on falls prevention. In addition to participating in the assigned condition, participants are asked to answer surveys that ask questions related to your balance, mental health, demographic information, and lifestyle. The surveys are sent before, during and at the end of the program.

• Study Type: Interventional
• Enrollment (Actual): 687
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94105
      • Hinge Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Balance Program; A digital program of exercise therapy, access to physical therapist and health coach, and educational articles on falls prevention.	Behavioral: Balance Program; 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.
Active Comparator: Comparison Group; Shared educational content on falls prevention and the importance of balance.	Other: Educational Reading Content; Informational articles on reducing risk for falls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fall Severity	How severe was the worst fall you experienced: none, minor, moderate, major	baseline to 3 months

Collaborators and Investigators

• Sponsor: Hinge Health, Inc
• Investigators: Study Director: Cynthia M Castro Sweet, PhD, Hinge Health, Inc

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2024
• Primary Completion (Actual): July 23, 2024
• Study Completion (Actual): November 1, 2024

Study Registration Dates

• First Submitted: March 6, 2025
• First Submitted That Met QC Criteria: March 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: older adults; exercise therapy; balance; telerehabilitation; falls prevention
• Other Study ID Numbers: 20240129

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: De-identified data are available from the study contact upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No