The Impact of Unilateral Lower Limb Amputation on Spinal Loads

September 25, 2023 updated by: Babak Bazrgari, PhD, University of Kentucky

Spinal Loads During Activities of Daily Living: Influences of Unilateral Lower-limb Amputation

The prevalence of low back pain among persons with unilateral lower limb amputation is significantly higher than the rate experienced by the general public. Chronic pain, including low back pain, limits functional independence and negatively impacts quality of life. As such, this project will investigate the role of a biomechanical casual pathway in the development of low back pain; to do this, the investigators will explore the relationship between the adopted neuromuscular patterns post-amputation to perform activities of daily living and the risk of developing spinal tissue damage.

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

Despite the higher prevalence of low back pain (LBP) among persons with unilateral lower limb amputation (ULLA) compared to able-bodied individuals, relatively little is known about the fundamental mechanisms underlying this condition. This research represents a first step toward investigating lower back biomechanics using advanced computational modeling techniques to inform the future design of effective interventions for LBP. Specifically, the impact of trunk neuromuscular patterns adopted by persons with ULLA while performing activities of daily living on spinal loads and the risk of spinal tissue damage will be investigated. This will be achieved via secondary biomechanical analyses of a large set of high-quality kinematics data obtained from individuals with and without ULLA performing the following tasks: 1) walking at self-selected and controlled speeds, 2) sit-to-stand and stand-to-sit, and 3) stairs-up and stairs-down. The central hypothesis is that, compared to able-bodied individuals, trunk movement strategies adopted by persons with ULLA to cope with physical demands of common daily activities are associated with a complex pattern of internal muscle forces that result in larger loads on the spine and a higher probability for spinal tissue damage. Investigators' dataset draws from the Biomechanics Laboratory at Walter Reed National Military Medical Center (WRNMMC) which has unprecedented access to a large population of service members with ULLA. Using this unique database, investigators will implement their novel finite element modeling approach to estimate the internal muscle forces (i.e., adopted neuromuscular patterns) needed to perform daily physical activities on the basis of satisfying equilibrium and stability across the entire lumbar spine. Completion of this project will enable the investigators to determine differences in muscle recruitment, as well as the resultant effects on spinal loads and the risk of spinal tissue damage, between persons with and without ULLA. Hence, this pilot project is expected to establish the initial groundwork for future research involving the design of highly specific interventions aimed at trunk neuromuscular behaviors during post-amputation rehabilitation to lessen adverse effects on lower back biomechanics and the potential for LBP.

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.
173

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

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

This project involves secondary analyses of existing data and so will not include a subject recruitment process. Kinematics data collected at Walter Reed National Military Medical Center will be used for estimation of internal muscle forces and the resultant spinal loads and the probability of spinal tissue damage during several basic activities of daily living using a computational model of the lower back. Following an initial assessment, the investigators estimate the following available sample sizes for each activity of daily living: (transfemoral-TFA, transtibial-TTA, and Controls-CTL ) 1) level ground walking at four different speeds (nTFA= 57, nTTA= 53, nCTL= 32), 2) sitting-to-standing and standing-to-sitting (nTFA= 29, nTTA= 20, nCTL= 15), and 3) stair ascending and descending tasks (nTFA= 18, nTTA= 20, nCTL= 15).

Description

Inclusion Criteria:

For individuals with amputation

  • unilateral amputation resulting from traumatic injuries (with no upper-extremity amputations)
  • evaluation took place at least 6 months post-injury
  • no assistive device use (e.g., canes, walkers, crutches)

For controls:

  • able-bodied individuals without amputation
  • to be matched with group with ampuation on the basis of anthropometric measure

Exclusion Criteria:

For individuals with amputation:

  • musculoskeletal impairments in the contralateral limb
  • neurologic disorder or traumatic brain injury that would affect gait and movement
  • pain levels greater than 3 out of 10 on a visual analog scale
  • a history of spinal pathologies/LBP prior to injury.

For controls

* a history of spinal pathologies/LBP

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

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.
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.
Transtibial lower limb amputation
unilateral amputation below knee resulting from traumatic injuries (with no upper-extremity amputations), evaluation took place at least 6 months post-injury, no assistive device use (e.g., canes, walkers, crutches), no other documented injuries, such as musculoskeletal impairments in the contralateral limb, neurologic disorder or traumatic brain injury that would affect gait and movement.
Other: Activity of daily living
walking, sitting-to-standing and standing-to-sitting, stairs ascending and descending
Transfemoral lower limb amputation
unilateral amputation above knee resulting from traumatic injuries (with no upper-extremity amputations), evaluation took place at least 6 months post-injury, no assistive device use (e.g., canes, walkers, crutches), no other documented injuries, such as musculoskeletal impairments in the contralateral limb, neurologic disorder or traumatic brain injury that would affect gait and movement.
Other: Activity of daily living
walking, sitting-to-standing and standing-to-sitting, stairs ascending and descending
Controls
Able-bodied individuals without amputation
Other: Activity of daily living
walking, sitting-to-standing and standing-to-sitting, stairs ascending and descending

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
Maximum value of summation of predicted forces in all trunk muscles
Time Frame: At least 6 months post-injury
All outcome measures are obtained from computational simulation of data collected in previous studies.
At least 6 months post-injury
Maximum spinal load at the lowest level of lumbar spine
Time Frame: At least 6 months post-injury
All outcome measures are obtained from computational simulation of data collected in previous studies.
At least 6 months post-injury

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 Kentucky

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.
Henry M. Jackson Foundation for the Advancement of Military Medicine

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: Babak Bazrgari, PhD, University of Kentucky

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

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.
September 1, 2011

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 1, 2015

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 1, 2015

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 2, 2016

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 7, 2016

First Posted (Estimated)

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, 2016

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.
September 28, 2023

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.
September 25, 2023

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.
September 1, 2023

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.
  • R03HD086512-01A1 (U.S. NIH Grant/Contract)

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings