Status:
NOT_YET_RECRUITING
Improving Walking After Spinal Cord Injury
Lead Sponsor:
Shirley Ryan AbilityLab
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Spinal Cord Injury
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
Locomotor recovery is one of the most important goals of individuals with spinal cord injury (SCI). Ambulatory deficits severely impact daily functions resulting in lower quality of life for people li...
Detailed Description
Individuals with chronic incomplete SCI will be randomly assigned to a group that will receive 10 sessions of a startle stimulus (a very brief, loud sound) and electrical stimulation combined with loc...
Eligibility Criteria
Inclusion
- History of traumatic or non-traumatic SCI ≥ 6 months
- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) level at and above T10.
- American Spinal Injury Association AIS Grade C, or D
- Weakness in ankle dorsiflexors (LEMS\<=3) with the ability to perform a small voluntary ankle dorsiflexion (as detected by presence of voluntary EMG activity in the tibialis anterior) with at least one leg.
- Ability to tolerate standing position.
- Ability to walk at a minimum speed of 0.1 mile/hour on a treadmill with less than 70% body weight support.
- Requires use of assistive devices (KAFO, AFO, cane, walker) or body weight support for ambulation.
- Ability to complete the 10-Meter Walk Test.
Exclusion
- Preceding uncontrolled medical conditions including pulmonary, cardiovascular or orthopedic disease that interfere with physical performance.
- Intolerance to physical activity.
- Severe cognitive impairment that precludes the ability to participate in any of the study procedures or give verbal consent.
- Any illness or condition that based on the research team's assessment, will compromise with the patient's ability to comply with the protocol, patient safety, or the validity of the data collected during the study.
- History of stroke resulting in sensory motor deficits.
- Pregnant women.
- Participation in a high-intensity locomotor training program in the last 6 months.
- Inability to detect somatosensory evoked potentials
- Metal implant in the head
- History of epilepsy
Key Trial Info
Start Date :
November 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07223710
Start Date
November 15 2025
End Date
July 30 2026
Last Update
November 3 2025
Active Locations (1)
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1
Shirley Ryan AbilityLab
Chicago, Illinois, United States, 60611