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Amplify Gait to Improve Locomotor Engagement in Spinal Cord Injury

NCT04340063 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-05-29

Study results available
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Summary

Spinal cord injury (SCI) affects \~42,000 Veterans. The VA provides the single largest network of SCI care in the nation. The lifetime financial burden of SCI can exceed $3 million. A major cost of SCI is impaired mobility. Limited mobility contributes to decreased ability to work, increased care requirements, secondary injury, depression, bone mineral density loss, diabetes, and decreased cardiovascular health. Among ambulatory individuals with iSCI, residual balance deficits are common and are strongly correlated with both functional walking ability and participation in walking activities. The development of effective rehabilitation tools to improve dynamic balance would substantially improve quality of life for Veterans living with iSCI. Improving mobility through interventions that enhance dynamic balance would positively impact health, independence, and the ability to integrate into social, intellectual, and occupational environments.

Conditions

  • Incomplete Spinal Cord Injury

Interventions

DEVICE

Gait training performed on a treadmill

Participants randomized to the Control group will complete high intensity gait training on a treadmill.

DEVICE

Gait training performed in a Movement Amplification Environment

The Experimental group will perform all gait training within the movement amplification environment. To create the movement amplification environment, the investigators have constructed a cable-driven robot, the Agility Trainer. The Agility Trainer applies small forces to the pelvis that increase the difficulty to maintain forward walking

Sponsors & Collaborators

Principal Investigators

  • Keith E Gordon, PhD · Edward Hines Jr. VA Hospital, Hines, IL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-15
Primary Completion
2024-03-31
Completion
2024-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04340063 on ClinicalTrials.gov