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

ConditionFall Risk
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-85
SponsorUniversity of Maryland, Baltimore

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Enrollment in another lower limb rehabilitation program;

severe pain in the lower limbs;

previous myocardial infarction

Body weight over 280 lbs

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Lab and home-based trainingExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Fall risks

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

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

Secondary outcomes

1

Lower limb muscle strength

The lower limb muscle strength will be measured manually by a researcher using dynamometry

Time frame
The first visit, immediately after the training, and a follow-up evaluation session two-month after the training
2

Ground impact forces captured by forces plates during walking

Subjects' ground impact forces captured by forces plates during multidirectional perturbations during walking.

Time frame
The first visit, immediately after the training, and a follow-up evaluation session two-month after the training
3

Body kinematcis during walking

Subjects' body kinematics measured by wearable IMUs during multidirectional perturbations during walking.

Time frame
The first visit, immediately after the training, and a follow-up evaluation session two-month after the training
4

Body reactions against perturbations

Subjects' body reactions to multidirectional perturbations during walking. Reactions include loss of balance, recovery steps, and falls, which will be identified by videos.

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

Other outcomes

Sponsors and contacts

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