Amplify Gait to Improve Locomotor Engagement in Spinal Cord Injury

Completed · Not applicable

Conditions studied: Incomplete Spinal Cord Injury

In brief

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.

Key facts

Study ID

NCT04340063

Run by

VA Office of Research and Development

People needed

38

Starts

2020-10-15

Expected to finish

2024-03-31

Last updated by the study team

2025-05-29

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Medically stable with medical clearance from a physician to participate
• Neurologic level of the SCI between C1-T10 with American Spinal Injury Association (ASIA) Impairment Scale (AIS) C or D
• > 6 months since initial injury
• Passive range of motion of the legs within functional limits and not restricting the ability to engage in locomotor training
• Able to ambulatory 10m with no physical assistance, use of assistive devices (e.g. single cane, rolling walker), and/or braces that do not cross the knee joint (e.g. ankle foot orthosis) are permitted
• Able to provide transportation to and from the testing location.

You may not qualify if…

• Excessive spasticity in the lower limbs as measured by a score of > 3 on the Modified Ashworth Scale
• Inability to tolerate 30 minutes of standing
• Severe cardiovascular and pulmonary disease
• History of recurrent fractures or known orthopedic problems in the lower extremities (i.e. heterotopic ossification)
• Concomitant central or peripheral neurological injury (i.e. traumatic head injury or peripheral nerve damage in lower limbs)
• Inability to provide informed consent due to cognitive impairments
• Presence of unhealed decubiti or other skin compromise
• Enrollment in concurrent physical therapy or research involving locomotor training
• Use of braces/orthotics crossing the knee joint
• Known pregnancy

Where it is running

• Edward Hines Jr. VA Hospital, Hines, IL — Hines, Illinois, United States

Full record on ClinicalTrials.gov

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