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

NCT06396650 | Recruiting DMC

• 1 other identifier: HP-00108616-
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fall Risk

Keywords

Fall prevention; Perturbation training; Multidirectional perturbation; Home-based training; Subject-specific training strategy

Outcome Measures

Primary Outcomes (1)

• Fall risks

  Berg Balance Scale (BBS) evaluation will be used which provides a value for fall risks assessment.

  The first visit, immediately after the training, and a follow-up evaluation session two-month after the training

Secondary Outcomes (4)

• Lower limb muscle strength

  The first visit, immediately after the training, and a follow-up evaluation session two-month after the training

• Ground impact forces captured by forces plates during walking

  The first visit, immediately after the training, and a follow-up evaluation session two-month after the training

• Body kinematcis during walking

  The first visit, immediately after the training, and a follow-up evaluation session two-month after the training

• Body reactions against perturbations

  The first visit, immediately after the training, and a follow-up evaluation session two-month after the training

Study Arms (1)

Lab and home-based training

EXPERIMENTAL

Conduct balance training and/or lower-limb muscle strengthening in lab and at home

Device: Home-based training; Device: Lab-based training

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 and home-based training

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.

Lab and home-based training

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 60 to 85 years old
• Have a family member at home for safety.
• There is no severe injury or pain at the lower extremities.
• With one or more falls in the past 12 months or walk with instability
• Individuals who are taking medication, there should be no planned medication changes for the study duration of 3.5 months.
• All the participants should be capable of independent walking.

You may not qualify if:

• Enrollment in another lower limb rehabilitation program;
• severe pain in the lower limbs;
• previous myocardial infarction
• Body weight over 280 lbs
• Cognitive impairment (Mini-Mental Status Examination (MMSE) score less than 25)

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Baltimore

Baltimore, Maryland, 21201, United States

RECRUITING

Study Officials

• Li-Qun Zhang

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zongpan Li

CONTACT

410-706-3242; zongpan.li@som.umaryland.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: May 2, 2024
• Study Start: December 1, 2025
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

US (1)