FallsNCT06868680
A Digital Balance Program With Comparison Group
A study testing Balance Program and Educational Reading Content in people with Falls, run by Hinge Health, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Falls
- What is being tested?
- Balance Program and Educational Reading Content
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 687 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2024to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Falls
- Being tested
- Balance Program, Educational Reading Content
- Keywords
- balance, falls prevention, older adults, exercise therapy, telerehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance ProgramBehavioural
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.
Educational Reading ContentOther
Informational articles on reducing risk for falls.
| Study group | Role | What they receive |
|---|---|---|
| Balance Program | Experimental | A digital program of exercise therapy, access to physical therapist and health coach, and educational articles on falls prevention. Receives: Behavioral: Balance Program |
| Comparison Group | Active comparator | Shared educational content on falls prevention and the importance of balance. Receives: Other: Educational Reading Content |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (1)
Fall Severity
How severe was the worst fall you experienced: none, minor, moderate, major
Measured: baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start16 Feb 2024
- Primary completion23 Jul 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FallsStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 687 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hinge Health, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cynthia M Castro Sweet, PhD, Study director, Hinge Health, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868680
- Sponsor's protocol ID
- 20240129
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified data are available from the study contact upon reasonable request
Publications
Phillips F, Yadav S, Sweet CC, Foster Kirk RN, Hong M, Mink S, Krauss J. Clinical effectiveness of a digitally delivered balance program for older adults: a nonrandomized controlled trial. J Comp Eff Res. 2026 Jul 21:e260070. doi: 10.57264/cer-2026-0070. Online ahead of print.
PubMed 42478779
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Balance Program Study With Comparison Group
- ClinicalTrials.gov ID
- NCT06868680
- Acronym / sponsor ID
- 20240129
- Conditions
- Falls
- Keywords
- balance, falls prevention, older adults, exercise therapy, telerehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 687 participants (actual)
- Lead sponsor
- Hinge Health, IncIndustry (pharma, biotech, devices)
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- 23 Jul 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balance Program | Experimental | Behavioral: Balance ProgramA digital program of exercise therapy, access to physical therapist and health coach, and educational articles on falls prevention. |
| Comparison Group | Active comparator | Other: Educational Reading ContentShared educational content on falls prevention and the importance of balance. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Balance ProgramA 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. | Behavioural | Balance Program |
| Educational Reading ContentInformational articles on reducing risk for falls. | Other | Comparison Group |
Primary outcome
Annualized fall rate
Time frame: 3 months
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
1 secondary outcome
Fall Severity
Time frame: baseline to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Derived from this study: PubMed 42478779Phillips F, Yadav S, Sweet CC, Foster Kirk RN, Hong M, Mink S, Krauss J. Clinical effectiveness of a digitally delivered balance program for older adults: a nonrandomized controlled trial. J Comp Eff Res. 2026 Jul 21:e260070. doi: 10.57264/cer-2026-0070. Online ahead of print.
- Individual participant dataSharing planned: Undecided. De-identified data are available from the study contact upon reasonable request
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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.
Cynthia M Castro Sweet, PhD study director
Hinge Health, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance Program and Educational Reading Content in people with Falls, run by Hinge Health, Inc 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 2 inclusion and 4 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 13 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Annualized fall rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06868680, which also lists 1 linked publication.
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 13 Mar 2025.