Upper Limb Loss Perturbation Response

NCT04274218 | Completed Results

• 2 other identifiers: A3290-P1I21RX003290-01A1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Recent investigations have suggested that persons with upper limb loss experience a high prevalence of falls with a quarter of reported falls resulting from a trip. Moreover, studies indicate that missing part of an arm may negatively impact balance and that use of a prosthesis exacerbates this problem. While the investigators are beginning to understand the effects of upper limb loss on balance, the understanding of how Veterans with upper limb loss respond to walking disturbances is incomplete. Therefore, the aims of this study are to observe the effects of upper limb loss and wearing a prosthesis on the preparation and recovery of Veterans who trip during walking. The investigators plan to use unique treadmill technology to deliver controlled, yet unexpected, perturbations to Veterans with upper limb loss and non-amputee controls, and assess walking stability through body dynamics. Results from this study will help us understand why Veterans with upper limb loss fall as a critical first step to addressing this problem through balance-targeted interventions that are integrated into patient care.

Conditions

Amputation

Keywords

Stability; Locomotion; Motor Control; Trip; Falls; Upper Limb Loss; Prosthesis; Arm

Outcome Measures

Primary Outcomes (1)

• Whole-body Angular Momentum in Sagittal-plane; Momentum of the Body in the Sagittal Plane of Walking Progression

  Whole-body angular momentum is the momentum of all limb segments about the Body Center of Mass (BCoM) summed. Whole-body angular momentum is estimated in the sagittal plane, which is the plane of walking progression, and the range of this value is normalized to a person's body mass, height, and walking speed. Whole body angular momentum is minimized by the central nervous system to facilitate postural control. For this study, whole body angular momentum range was averaged across the 12 perturbation trials and then across all participants. To note, the reported whole body angular momentum values are the relative increase from baseline to perturbation recovery that are all measured in the same session. There are no additional sessions as the baseline whole body angular momentum reflects those values before the perturbation trials.

  1 hour

Secondary Outcomes (3)

• Shoulder Angle Flexion-extension Range

  1 hour

• Trunk Flexion Angle

  1 hour

• Trunk Flexion Velocity

  1 hour

Study Arms (2)

Walking perturbation - Free

EXPERIMENTAL

Healthy controls without limb loss and individuals with upper limb loss between the wrist and elbow will receive a treadmill belt disturbance while walking. Able-bodied individuals will walk with both arms free and individuals with amputation will walk with their prosthesis.

Other: Perturbation

Walking perturbation - Limited

EXPERIMENTAL

Healthy controls without limb loss and individuals with upper limb loss between the wrist and elbow will receive a treadmill belt disturbance while walking. Able-bodied individuals will walk with one arm bound to their side with straps and individuals with amputation will walk without their prosthesis.

Other: Perturbation

Interventions

Perturbation OTHER

Participants from both cohorts will experience a simulated trip while walking on the treadmill. The trip is induced through a rapid acceleration and deceleration of the treadmill belt speed.

Walking perturbation - Free; Walking perturbation - Limited

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 18 and 65 years
• normal or corrected vision
• able to walk unassisted for 20 minutes without undue fatigue or health risks
• unilateral ULL at the transradial level
• most recent major upper limb amputation occurred at least one year prior to study
• residuum and amputated side in good condition (no scars, infections, pain, etc.)
• habitual experience using an upper limb prosthesis for at least one year
• a self-reported comfortable prosthetic suspension

You may not qualify if:

• self-reported additional neurological, vascular, or musculoskeletal pathologies (other than ULL when applicable) that may affect proprioception/balance
• self-reported medication that may affect proprioception/balance, e.g.:
• drugs that are ototoxic, such as certain Aminoglycosides and pain killers
• cognitive deficits that preclude understanding of the study instructions
• presence of osteoporosis
• presence of pacemakers or stents that may be irritated by the chest harness

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, 60612, United States

Location

Results Point of Contact

• Title: Matthew Major
• Organization: US Department of Veterans Affairs

matthew.major2@va.gov

3125035731

Study Officials

• Matthew J. Major, PhD

  Jesse Brown VA Medical Center, Chicago, IL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants will receive a small treadmill belt disturbance while walking.

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 18, 2020
• Study Start: December 11, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: November 14, 2024
• Results First Posted: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)