The Impact of Unilateral Lower Limb Amputation on Spinal Loads

NCT ID: NCT02897973

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 173 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2015-10-31

Brief Summary

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.

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.

Conditions

Low Back Pain

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Activity of daily living

Intervention Type: OTHER

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.

Activity of daily living

Intervention Type: OTHER

walking, sitting-to-standing and standing-to-sitting, stairs ascending and descending

Controls

Able-bodied individuals without amputation

Activity of daily living

Intervention Type: OTHER

walking, sitting-to-standing and standing-to-sitting, stairs ascending and descending

Interventions

Activity of daily living

walking, sitting-to-standing and standing-to-sitting, stairs ascending and descending

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Henry M. Jackson Foundation for the Advancement of Military Medicine

OTHER

Sponsor Role: collaborator

University of Kentucky

OTHER

Sponsor Role: lead

Responsible Party

Babak Bazrgari, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Babak Bazrgari, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Other Identifiers

R03HD086512-01A1

Identifier Type: NIH

Identifier Source: org_study_id

View Link