Recruiting

Fall Prevention

Sponsor:

University of Maryland, Baltimore

Code:

NCT06396650

Conditions

Fall Risk

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

Interventions

Home-based training

Lab-based training

Study Details

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

Study ID

NCT06396650

Start date

Dec 1, 2025

Status verified date

Feb, 2026

Completion date

Apr 30, 2029

Anticipated

Primary completion date

Apr 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Lab and home-based training

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

Interventions

Home-based training

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

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.

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 and Locations

Central contacts

Zongpan Li

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

Locations

University of Maryland Baltimore

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Li-Qun Zhang, Ph.D.

410-706-2125L-Zhang@som.umaryland.edu

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Feb 10, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-02-10.