FOPLL: Falls in Older Persons With Limb Loss

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT03670004
Collaborator
(none)
12
1
44.9
0.3

Study Details

Study Description

Brief Summary

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 who have fallen twice or more in the past 12 months and those who have fallen once or less, and compare both groups to data from 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.

Condition or Disease Intervention/Treatment Phase

    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 three age- and gender-matched groups: 1) amputees who reported two or more falls in the past 12 months, 2) amputee controls (one fall or less in the past 12 months), and 3) able-bodied controls.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    12 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Sensory-Motor Mechanisms Underlying Fall Risk in Transtibial Amputees
    Actual Study Start Date :
    Feb 2, 2017
    Actual Primary Completion Date :
    Oct 31, 2020
    Actual Study Completion Date :
    Oct 31, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Unilateral Below Knee Amputation

    Individuals who walk with a below knee prosthesis

    Non-Impaired

    Able-bodied controls

    Outcome Measures

    Primary Outcome Measures

    1. Gait Biomechanics [1 month]

      Kinetics and Kinematics of self-selected normal and fast speed walking

    2. Standing Balance Biomechanics [1 month]

      Center of pressure sway and velocity

    3. Gait Muscle Activation [1 month]

      Electromyographic patterns of lower limb muscles during self-selected normal and fast speed walking

    Secondary Outcome Measures

    1. Falls [1 year]

      Number of falls during 12 months

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jesse Brown VA Medical Center, Chicago, IL Chicago Illinois United States 60612

    Sponsors and Collaborators

    • VA Office of Research and Development

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    VA Office of Research and Development
    ClinicalTrials.gov Identifier:
    NCT03670004
    Other Study ID Numbers:
    • C1322-W
    • IK2RX001322
    First Posted:
    Sep 13, 2018
    Last Update Posted:
    Nov 18, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by VA Office of Research and Development

    Study Results

    No Results Posted as of Nov 18, 2020