Assessment of Fall Risks and Subject-specific Training for Fall Reduction

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT06396650
Status
Recruiting

Conditions

  • Fall Risk

Eligibility Criteria

Sex
ALL
Age
60 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Home-based training — DEVICE
    1. If the participant shows instability in any specific perturbation directions or with excessive body swaying, the participant will practice walking with a cellphone strapped on the chest in-home training. A cellphone App will detect potential excessive body swaying in any directions and prompt the participant with real time audio-visual feedback to reduce sway in the specific directions. 2. If the subject is diagnosed with collapse-related vertical instability, lower-limb muscle strengthening will be emphasized in the training. The subject may work out with a Shuttle Mini-Press, AB Squat machine, Rowing machine, or Upright Row-n-Ride. The Investigators will select one machine appropriate for the subject to take home. The exercise will be 3-5 sets a day and about 15 repetitions per set. In the beginning, the exercise can be slower and with fewer repetitions based on the subject's capability. As the subject progresses, the subject may change from one exercise machine to another.
  • Lab-based training — DEVICE
    In the weekly lab-based training session, the subject will do individualized training using the sliding stepping trainer, with a focus on the direction the subject showed higher risks of falling, as identified in the initial assessment. The sliding stepping trainer will generate perturbations of the footplates in those identified risky directions during stepping.

Study Details

The target population of this project is older people with high risks of falls. About 30% community-dwelling individuals over 65 years of age fall each year and the rate of fall related injuries leading to loss of function and independence increases with age. Falls are the leading cause of fatal and non-fatal injuries and the leading cause traumatic brain injury in older adults. Slip-related falls in older adults comprise 40% of outdoor falls and are the leading cause of hip fracture or traumatic head injury. In 2012, 2.4 million non-fatal falls were treated in emergency room visits with $30 billion dollars spent on direct medical costs. In addition to fractures and traumatic brain injury, nonfatal falls frequently lead to reduced levels of activity, fear of falling, and reduced quality of life. Clearly, advancing the predictive, preventative, and rehabilitative methods aimed at reducing the risk of injurious falls in this population is imperative. Although falls are multi-factorial in nature, there has been few individualized assessment of the biomechanical causes of falls. The purpose of this study is to conduct subject-specific training on older adults with fall risks with combined home-hospital rehabilitation. This project will involve rehabilitation interventions based on the characteristics of falling patterns and older adults with reduced capability controlling the balance. To conduct subject-specific fall prevention training. based on identified individual fall mechanisms.

Key Dates

Start date
Dec 1, 2025
Status verified
Feb 2026
Primary completion
Apr 30, 2029
Completion
Apr 30, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Lab and home-based training
    Conduct balance training and/or lower-limb muscle strengthening in lab and at home

Primary Outcome Measure

Fall risks [ Time Frame: The first visit, immediately after the training, and a follow-up evaluation session two-month after the training ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland BaltimoreBaltimoreMaryland21201
Li-Qun Zhang, Ph.D.
410-706-2125

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