Improving Walking After Spinal Cord Injury
ConditionSpinal Cord Injury
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShirley Ryan AbilityLab
About this trial
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 living with paralysis due to SCI. Although studies have shown that locomotor training improves locomotor function in people with chronic SCI, the benefits remain limited. Our overall hypothesis is that we can engage additional descending motor pathways, such as the reticulospinal tract (RST), to improve locomotor function in humans with chronic incomplete SCI.
In this study we propose to test the effects of a novel intervention that uses repeated paired loud auditory and electrical stimulation of muscle afferents combined with locomotor training on walking speed and voluntary muscle strength.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Paired Associative Stimulation
- Locomotor Training
- Sham stimulation
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Shirley Ryan AbilityLab
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov