Falls in Older Persons With Limb Loss (FOPLL)

April 6, 2022 updated by: VA Office of Research and Development

Sensory-Motor Mechanisms Underlying Fall Risk in Transtibial Amputees

Lower limb prosthesis users are known to be at a substantially increased fall risk compared to able-bodied individuals. The interaction between increased fall risk, reduced balance confidence and high prevalence of a fear of falling often leads to restricted mobility and loss of independence. Critically, the cause of these falls and the role that inherent balance plays in fall risk is poorly understood. This study proposes to identify key differences in balance and mobility between older below-knee prosthesis users and able-bodied individuals. By further understanding the differences between these groups and relationships between fall risk and various outcome measures, intervention techniques can be developed to improve functional balance. An improvement in upright balance will reduce the occurrence of falls and fall related injuries in this veteran population, as well as increase their participation in daily activities and improve their quality of life.

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.

Detailed Description

Previous studies have shown that persons with transtibial amputations (TTA) are at a substantially increased risk of falling as compared to able-bodied age-matched controls and have reduced confidence in their balance, both contributing to their restricted mobility and daily activity. This risk increases with progressing age, as aging affects musculoskeletal and somatosensory systems that are vital to controlling upright balance (i.e., maintaining the body center-of-mass (BCoM) within the limits of the base-of-support) and are already compromised in persons with TTA. An important consequence of elevated fall incidence is an increased risk of fall-related injuries that may lead to lost participation and independence. The effects of reduced sensory-motor function on upright balance in older adults has been extensively studied and led to development of effective assessment tools and intervention strategies to minimize fall risk. However, the dearth of similar studies and relatively poor understanding of the effects of additional complications from TTA on upright balance have significantly hampered progress towards addressing this important concern for Veterans with TTA. Consequently, this limits knowledge of predictive factors of falls among these prosthesis users and for informing therapeutic interventions that enhance functional balance. Therefore, the primary objective of this research is to develop an improved understanding of the sensory-motor mechanisms underlying upright balance and fall risk in older Veterans with TTA. The proposed study will compare differences between two age- and gender-matched groups: 1) older unilateral prosthesis users and 2) able-bodied controls.

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.
Observational

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.
23

Contacts and Locations

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

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Jesse Brown VA Medical Center, Chicago, IL

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 to 85 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Older ambulatory individuals with or without unilateral below-knee amputation

Description

Inclusion Criteria:

Inclusion criteria for the recruitment of subjects with below knee amputation include:

  • Transtibial amputation
  • Daily use of their clinically-prescribed prosthesis for ambulation without an assistive device
  • Classified as Medicare Functional Classification Level K2- defined as a patient who "has the ability or potential for ambulation with the ability to traverse low-level environmental barriers such as curbs, stairs, or uneven surfaces - a typical community ambulator"
  • Experience walking with a prosthesis for at least one year
  • Residuum and amputated side in good condition (e.g., no adherent scars, lesions, ulcers, infections)
  • Normal or corrected vision
  • Able to walk a 10 m distance and stand quietly for 40 seconds without undue fatigue or health risk

Inclusion criteria for the recruitment of able-bodied controls include:

  • Normal or corrected vision
  • Able to walk a 10 m distance and stand quietly for 40 seconds without undue fatigue or health risk
  • Suffered one or no falls in the previous 12 months

Exclusion Criteria:

Exclusion criteria for all recruited subjects (i.e., limb loss and control) include:

  • Musculoskeletal (apart from amputation in the case of amputee subjects) and/or vestibular pathologies that would affect balance and/or stability
  • Currently on medication that might affect proprioception and/or balance (e.g., drugs that are ototoxic, such as certain Aminoglycosides and pain killers)
  • Cognitive deficits that preclude understanding of the instructions required to conduct the test

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Unilateral Below Knee Amputation
Individuals who walk with a below knee prosthesis
Non-Impaired
Able-bodied controls

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
Foot's Height During the Swing Phase of Walking (i.e., Foot Clearance) Measured in Centimeter
Time Frame: 1 month
Foot clearance of self-selected normal and fast speed walking, calculated as the distance (cm) between the toe and ground as measured with an optical motion capture system.
1 month
Center of Pressure Sway Area During Eyes Open or Closed as Measured Through a Force Plate During Standing and Calculated as Centimeters Squared
Time Frame: 1 month
Center of pressure sway area during eyes open or closed, calculated as the area (cm*cm) covered by the center of pressure position during standing as measured with a force plate.
1 month
Gait Muscle Activation Effort as Measured by Sensors and Integrating Measured Voltage With Respect to Time as to be Calculated as Millivolts Times Seconds
Time Frame: 1 month
Integrated Electromyography patterns of leg muscles during self-selected normal and fast speed walking as a proxy measure of muscle effort, calculated from integrating the muscle activity measured by sensors as voltage over time (mv*sec)
1 month

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
Falls
Time Frame: 1 year
Number of falls during 12 months prospectively
1 year

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.
VA Office of Research and Development

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: Matthew J. Major, PhD, Jesse Brown VA Medical Center, Chicago, IL

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.
February 2, 2017

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.
October 31, 2020

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.
October 31, 2020

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).
September 11, 2018

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.
September 11, 2018

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.
September 13, 2018

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 7, 2022

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.
April 6, 2022

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.
April 1, 2022

More Information

Terms related to this study

Keywords

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.
  • C1322-W
  • IK2RX001322 (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

product manufactured in and exported from the U.S.

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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