Minimizing Fall-Related Injury in Older Adults: a Motor Learning Approach

November 4, 2024 updated by: University of Kansas Medical Center
Falls are the leading cause of accidental injury and injury-related death among older adults. Despite evidence that falls can be prevented, fall related injuries have not declined over time. Current fall injury prevention techniques targeting mobility and bone strength have merit yet their effectiveness is limited. Indeed, a recent Patient Centered Outcomes Research Institute/National Institute on Aging funded pragmatic trial of individualized multifactorial strategy to prevent serious fall injuries in over 5500 seniors revealed no difference in fall injuries between the intervention and standard care arm. The inconclusive results of the investigation may be due in part to focusing on fall prevention rather than mitigation of fall-related impact acceleration and forces - the "fundamental variables" for injury prevention. A fall-related injury occurs when the body hits the ground with force that is greater than tissue strength. Development of innovative approaches that focus on fundamental variables of injury prevention is needed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Impact forces and body accelerations can be mitigated by performing specific movement patterns during the impact phase of a fall. The investigators, along with others have postulated and provided preliminary evidence that older adults can learn specific movement patterns (enacted during the impact phase of a fall), such as the tuck and roll that significantly reduce impact forces and minimize the risk of injury. The investigators' recent Randomized Clinical Trial (RCT) that examined the FAlling Safely Training (FAST) program in 17 older adults with low fall risk found that following 2 hours of training, the FAST group reduced their hip impact force by 33% and head acceleration by 59% and demonstrated retention. The procedures were feasible and safe in relatively healthy older adults with low fall risk. Despite the promise of this approach, perhaps the most important issue for real world translation is whether at-fall risk older adults with known balance impairment, a key target group who would most benefit from this training, can safely learn to fall with reduced impact forces and thus potentially fewer injuries using this paradigm. The immediate goal of this investigation is to determine the safety and feasibility of FAST training in an at-fall risk older adult group, the key measurable stages of FAST mastery, and, most importantly, the effect size, compared to modified Otago Exercise Program (an evidence-based fall risk reduction program) controls, to inform a larger future trial. To maximize safety, participants will utilize a protective helmet, and hip protector while landing on a cushioned pad. In addition, using a motor learning approach, the investigators will determine and measure key stages of the technique that can be mastered and measured as intermediate measures to document training progression.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66103
        • Emma Eells

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have balance impairment as indicated by <10s on unipedal stance
  • History of fall injury in the last year; or, two more falls in the last year; or, afraid of falling because of problems with balance or walking
  • Have no history of tumbling, gymnastic or martial art experience or currently engagement of 150+ minutes/week of vigorour aerobic activity
  • No clinical osteoporosis
  • DEXA (dual energy X-ray absorptiometry) determined bone mineral density of the hip of t is greater than or equal to -2.3

Exclusion Criteria:

  • Outside of age range
  • Unable to speak or comprehend written/spoken English
  • Cognitive impairment as indicated by Saint Louis University Memory Scale (<25)
  • Unable to ambulate household distances
  • Intact standing balance as indicated by >10s of unipedal stance
  • Currently receiving physical therapy
  • Presence of clinical osteoporosis
  • Uncorrected vision or hearing or vestibular dysfunction
  • Major neurological conditions, such as stroke, Parkinson's Disease, vertigo that affect the ability to ambulate or perform daily tasks
  • Currently taking medications, including, coumadin, dual oral anticoagulants (apixaban, rivaroxaban), lovenox
  • Conditions may lead to (internal) bleeding, such as thrombocytopenia, hemorrhagic diathesis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Otago Group
The control group will receive balance exercises adapted from the evidenced-based Otago Exercise program. Briefly, all eight sessions (~30 min) will involve balance exercises and strength exercises using ankle weights, and will progressively increase as performance improves by increasing resistance or the difficulty of the balance exercises (e.g., reducing base of support).
Other: Otago Exercise Program
The Otago Exercise Program (OEP) was chosen, rather than no control intervention, to increase the level of evidence required to demonstrate efficacy, and because, similar to the safe fall training used here, it was designed to be performed individually or in small groups.
Experimental: FAST Group
Participants randomized to the intervention arm will undergo the FAST program, a progressive safe-falling training based on the tuck and roll strategy. As part of the FAST program, participants will train 30 minutes twice a week for a period of four weeks under the supervision of a trained researcher. Participants will wear protective gear (knee, hip, head) and they will complete a 10-minute stretching exercise routine to minimize the risk of injury.
Other: FAST Program
This program aims to teach how to effectively reduce impact forces during a sideways fall by 1) changing the trunk/knee angles during descent to decrease body acceleration, 2) using a rolling movement to allow for an optimal distribution of impact forces applied to any site along the contact path; and 3) tucking the chin to protect the head.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Physical discomfort related to the intervention
Time Frame: The physical discomfort scale will be utilized through the participant's involvement in the study, approximately five months.
The hypothesis is that there will be minimally greater musculoskeletal discomfort in the FAST group that than in the Otago Exercise Program group, but no difference in adverse events. Physical discomfort will be recorded by an 11-point numerical rating scale (ranging from 0, no discomfort to 10, worst imaginable discomfort). Participants will self-report their discomfort, including the physical location and severity on a standardized body map.
The physical discomfort scale will be utilized through the participant's involvement in the study, approximately five months.
Participant ability to master the intervention
Time Frame: Feasibility will be measured during the intervention, which will last four weeks.
The investigators hypothesize that at least 2/3 of FAST participants will pass through a series of technique mastery and eventually progress to the final stage of the training. Mastery of technique will be measured by scoring the participants' technique based on predetermined, standardized competency criteria.
Feasibility will be measured during the intervention, which will last four weeks.
Determining FAST efficacy in reducing hip impact force, versus Otago Exercise Program (OEP).
Time Frame: The outcome will measured at the baseline, one-week post-intervention, and three-months post-intervention.
The first part of the hypothesis postulates that when compared to baseline, FAST participants will show greater reduction in hip impact force than OEP participants immediately post-training. The second part of the hypothesis postulates that compared to baseline, FAST participants will show greater reduction in hip impact force than OEP participants at three months post-training. The impact velocity and impact acceleration of the hip will be computed based on the hip trajectory recorded by motion capture system.
The outcome will measured at the baseline, one-week post-intervention, and three-months post-intervention.
Determining FAST efficacy in reducing head acceleration, versus Otago Exercise Program (OEP).
Time Frame: The outcome will be measured during the baseline, one-week post-intervention, and three-months post-intervention.
The first part of the hypothesis postulates that when compared to baseline, FAST participants will show greater reduction in head acceleration than OEP participants immediately post-training. The second part of the hypothesis postulates that compared to baseline, FAST participants will show greater reduction in head acceleration than OEP participants at three months post-training. Information will be collected on upper limb impact by utilizing conformal sensors during falls.
The outcome will be measured during the baseline, one-week post-intervention, and three-months post-intervention.
Number of adverse events
Time Frame: AEs and SAEs will be monitored through participant involvement of the study, approximately five months.
Any adverse events (AEs) and serious adverse events (SAEs) will be recorded on the Council for International Organizations of Medical Sciences' CIOMS-E2A form by the researchers. The definition of adverse event and serious adverse events will follow that of the International Council for Harmonization.
AEs and SAEs will be monitored through participant involvement of the study, approximately five months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The number of head impacts
Time Frame: The outcome will be measured during the baseline, one-week post-intervention, and three-months post-intervention.
The number of times that the head makes contact with the ground will be recorded at each assessment.
The outcome will be measured during the baseline, one-week post-intervention, and three-months post-intervention.
The movement strategy of falls
Time Frame: The trunk angle, knee angle and trunk rotation of each fall will be assessed at all assessments (baseline, one-week post-intervention, and 3-month follow-up).
The trunk angle, knee angle and trunk rotation at impact will be calculated based on the motion capture data, which will measure the body's angles and rotation during the fall. Each assessment will have the right and left side falls for 2 trials each and 2 backward falls, in a total.
The trunk angle, knee angle and trunk rotation of each fall will be assessed at all assessments (baseline, one-week post-intervention, and 3-month follow-up).

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Balance
Time Frame: BBS will be assessed at all assessments (baseline, one-week post-intervention, and 3-month follow-up). Each assessment will last about 1.5 hours.
Balance will be quantified by the Berg Balance Scale (BBS). This is a 14-item object measure of static balance and fall risk in older adults. The 14 items range from quiet standing, to sit to stand, to tandem standing. Each item is scored 0-4 (unable to complete to successful completion) and the item scores are summed with a total of 56 for maximal performance.
BBS will be assessed at all assessments (baseline, one-week post-intervention, and 3-month follow-up). Each assessment will last about 1.5 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Kansas Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jacob Sosnoff, PhD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 18, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 5, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 5, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00147362
  • R21AG073892 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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