Status:
COMPLETED
Amplify Gait to Improve Locomotor Engagement in Spinal Cord Injury
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
Northwestern University
Conditions:
Incomplete Spinal Cord Injury
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 SC...
Detailed Description
Background: Among ambulatory individuals with incomplete spinal cord injury (iSCI), residual balance deficits are common and are a primary factor limiting participation in walking activities. There i...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
October 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2024
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04340063
Start Date
October 15 2020
End Date
March 31 2024
Last Update
May 29 2025
Active Locations (1)
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1
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States, 60141-3030