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Old Age; DebilityNCT07824141

Fall Prevention Pathways

A study testing The Fall Prevention Pathway (FPP) in people with Old Age; Debility, run by Emory University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Falls are a leading cause of injury and loss of independence in older adults, with evidence supporting exercise-based interventions and remote monitoring as effective strategies for reducing fall risk. However, adherence and engagement with such programs remain significant challenges. Read more about this study

Who is it for?
Ages 65 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Old Age; Debility
What is being tested?
The Fall Prevention Pathway (FPP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
29 Sep 2025to Sep 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Adults aged 65-85 years
  • Community-dwelling individuals classified as low to moderate fall risk based on standardized assessments, (i.e., the Stay Independent Screener)
  • Ability to ambulate independently or with a single-point cane
  • Willingness to participate in an 8-week intervention with remote monitoring
  • Access to a smartphone, tablet, or computer with internet connectivity
  • Ability to provide informed consent

Who cannot join

  • Severe cognitive impairment or a diagnosis of dementia that would affect adherence or ability to provide consent
  • Neurological or vestibular disorders (e.g., Parkinson's disease, multiple sclerosis, history of stroke with residual balance impairment)
  • Severe comorbidities that significantly impact mobility and function (e.g., recent orthopedic surgery, unstable cardiac conditions)
  • Significant visual or hearing impairments that prevent engagement with digital health interventions
  • Non-ambulatory or requiring assistance of another person for mobility

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Madeleine E. Hackney, Ph.D. contact

314-412-4852

mehackn@emory.edu

United States1 site, 1 recruiting
  • Executive Park

    Atlanta, Georgia, 30329

    Madeleine E. Hackney, PhD, 314-412-4852, mehackn@emory.edu

    Recruiting

Other trials in United States

About this study

Official title: Feasibility, Acceptability and Adherence of the Fall Prevention Pathways With Remote Monitoring

Falls are a leading cause of injury and loss of independence in older adults, with evidence supporting exercise-based interventions and remote monitoring as effective strategies for reducing fall risk. However, adherence and engagement with such programs remain significant challenges.

This study builds on prior research demonstrating the feasibility of digital health interventions in rehabilitation and extends it to a structured, remotely monitored Fall Prevention Pathway (FPP). Preliminary work in digital rehabilitation has shown positive engagement and clinical outcomes, supporting the need for further exploration of feasibility, adherence, and cost implications of remotely monitored fall prevention programs.

Read the detailed description

This study will evaluate the Fall Prevention Pathways (FPP) program, a digital rehabilitation intervention that assesses the impact of remote monitoring in reducing fall risk in community-dwelling older adults.

Participants will be enrolled in an 8-week intervention and followed for an additional 6 months. The study will assess feasibility, patient adherence, engagement, clinical outcomes, and cost implications. Data collection will occur at baseline (0 weeks), post-intervention (8 weeks), and follow-ups at 13 weeks (3 months) and 26 weeks (6 months).

Being tested
The Fall Prevention Pathway (FPP)
Keywords
Older adults, Fall risk, Digital Program
Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The Fall Prevention Pathway (FPP)Behavioural

    The Fall Prevention Pathway (FPP) is a digital progression of exercises \& patient education delivered through a web platform designed to improve balance, boost confidence, and reduce fall risk. The FPP enrolls participants in a Medbridge Pathway and provides remote monitoring by a clinician who personalizes programs and provides verbal education to help reduce fall risk.

Study groups in NCT07824141
Study groupRoleWhat they receive
The Fall Prevention Pathway (FPP)ExperimentalParticipants will be enrolled in an 8-week FPP intervention program. After completion of the 8-week FPP intervention, participants will undergo long-term follow-up assessments at 13 weeks (3 months) and 26 weeks (6 months) post-intervention. The follow-up assessments aim to assess sustained engagement, adherence, clinical outcomes, and fall incidence.
Receives: Behavioral: The Fall Prevention Pathway (FPP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence to program

    Adherence will be measured as the number of participants who complete ≥3 days of activity per week

    Measured: At the end of the intervention (8 weeks)

  2. Number of participants who complete the intervention

    Number of participants (Retention rate) who remain in the study

    Measured: 3 months and 6 months post-intervention

Secondary outcomes (9)
  1. 30-Second Sit-to-Stand test

    The number of sit-to-stand maneuvers completed in 30 seconds is used to measure leg strength and endurance. A higher score is better.

    Measured: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)

  2. Gait speed over 20 feet

    Gait speed testing (Forward/Backwards/Fast): How quickly a person can walk within a 20-foot distance forward and Backwards using GAITRite. GAITRite is a pressure-sensitive walkway that can assess gait anomalies. Lower scores are better.

    Measured: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)

  3. Timed Up and Go Simple and Dual tasks (TUG, TUG Cognitive and TUG Manual)

    Measures the time it takes to rise from a chair, walk 3 meters, turn around, and return to the chair in the simple condition. In the Cognitive condition, one is required to simultaneously count backward by 3s from a number between 20 and 100; in the Manual condition, one is required to simultaneously pick up a cup of water and carry it while completing the task. A lower score is a better outcome.

    Measured: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)

  4. Tandem stance (from 4 stage balance test),

    The tandem stance in the 4-Stage Balance Test is a static balance position where the participant stands with one foot directly in front of the other, with the heel of the front foot touching the toes of the back foot. It assesses static balance and postural stability by significantly narrowing your base of support. Screens for fall risk, specifically in older adults.

    Scoring: Time tracked: Measured using a stopwatch up to 10 seconds with eyes open. Pass criteria: Must maintain the heel-to-toe position for 10 full seconds without moving the feet or grabbing support/the tester.

    Stop condition: The test stops immediately if the person cannot reach the 10-second mark, meaning their final score is recorded at the highest stage successfully completed.

    Measured: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)

  5. Short Form 12-Quality of Life (SF12)

    The SF12 evaluates the level of activity and perceived physical and mental quality of life.

    The SF-12 uses a standardized system with scores ranging from 0 to 100, where the general population's average is 50, with higher scores indicating better health. Because it measures relative deviation, the numbers represent the following health levels:

    Above 50: Better than average health. Exactly 50: Average health status. 40 to 50: Below average health (mild disability or impairment). 30 to 40: Moderate disability or impairment. Below 40: Severe impairment or disability.

    Measured: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)

  6. Falls Efficacy Scale (FES-I)

    The Falls Efficacy Scale-International (FES-I) measures a person's level of concern or fear about falling while performing 16 everyday indoor and outdoor activities. Each activity is rated on a 4-point Likert scale from 1 to 4; with 1 = Not at all concerned; 2 = Somewhat concerned; 3 = Fairly concerned and 4 = Very concerned. All 16 item scores are added together for the final sum.

    Minimum Score: 16 (indicates no concern about falling) Maximum Score: 64 (indicates severe or extreme concern about falling)

    Measured: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)

  7. Activities-specific Balance Confidence Scale (ABC)

    The Activities-specific Balance Confidence (ABC) Scale is a 16-item self-report questionnaire used to measure an individual's confidence in performing daily activities without losing their balance or feeling unsteady. Participants rate their self-confidence on a percentage scale from 0% (no confidence) to 100% (completely confident) for 16 specific tasks.

    The total score is added for all 16 items and divided by 16 to get the average percentage score.

    ≥ 80%: Indicates a high level of physical functioning and balance confidence. 50% to 80%: Indicates a moderate level of physical functioning. < 50%: Indicates a low level of physical functioning.

    Higher scores indicate a higher level of functioning and a lower risk of falling, while lower scores (below 67%) often indicate a higher risk of falling.

    Score Interpretation:

    16-19: Low concern about falling 20-27: Moderate concern about falling 28-64: High concern about falling

    Measured: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)

  8. Physical Activity Scale for the Elderly (PASE)

    The PASE score combines information on leisure, household, and occupational activity. The PASE assesses the types of activities typically chosen by older adults (walking, recreational activities, exercise, housework, yard work, and caring for others. It uses frequency, duration, and intensity level of activity over the previous week to assign a score, ranging from 0 to 793, with higher scores indicating greater physical activity.

    Measured: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)

  9. Net Promoter Score (NPS)

    The Net Promoter Score (NPS) will be used to measure the participants' satisfaction. A Net Promoter Score (NPS) is a customer loyalty and satisfaction metric that measures how likely a person is to recommend a company, product, or service to a friend or colleague. Businesses ask one simple survey question: "On a scale of 0 to 10, how likely are you to recommend us?"

    Promoters (Score 9-10): Loyal and enthusiastic fans who will keep buying and tell others.

    Passives (Score 7-8): Satisfied customers who are unenthusiastic and vulnerable to competitors.

    Detractors (Score 0-6): Unhappy customers who can damage your brand through negative word-of-mouth

    Measured: 8 weeks (end of the intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2026
  2. Study start29 Sep 2025
  3. Primary completionSep 2028 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Model description
Community-dwelling adults aged 65-85 years with low to moderate fall risk.
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07824141
Sponsor's protocol ID
2025P011033
Status last verified
Sep 2026
First submitted
11 Sep 2026
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing The Fall Prevention Pathway (FPP) in people with Old Age; Debility, run by Emory University 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 17 Sep 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Madeleine E. Hackney, Ph.D. (314-412-4852, mehackn@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence to program (time frame: At the end of the intervention (8 weeks)). The study lists 2 primary outcomes in all. 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 17 Sep 2026.

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