Exoskeleton and Spinal Cord Stimulation for SCI
Kessler Foundation
Summary
The overall aim of this project is to assess the effect of combining transcutaneous lumbosacral stimulation (TLS) during Exoskeleton Assisted Walking (EAW) compared to EAW alone without stimulation on walking recovery.
Description
In this study, a total of 24 participants with an incomplete spinal cord injury (iSCI) will be randomly assigned to an EAW+TLS group or an EAW alone intervention group. Each group of subacute to chronic sensory and motor iSCI will be composed of 12 participants. On the average five participants will be trained per year. Each group will receive 60 minutes of robotic intervention training per session, for a total of 80 sessions (3 times a week, for 28 weeks). Group 1: The EAW + TLS group will receive 60 minutes of exoskeleton-assisted walking overground with simultaneous TLS followed by 15 minut…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: In order to be eligible to participate in this study a participant must: * be a non-walker with an SCI greater than 6 years post injury; * have a lower extremity motor score greater or equal to 16 as measured by the International Standards for Neurological Classification of SCI exam; * be between the ages of 18-65 years old; * have a spinal cord injury at a neurological level of injury as determined by study staff between C5-T-10; * be wheelchair reliant 100% of the time; * have knee bone mineral density great than .5755gm/cm2 as determined by study staff; Exclusion Crit…
Interventions
- DeviceExoskeleton-Assisted Walking
Exoskeleton-Assisted Walking (EAW) is an activity based therapy. Each group will receive 60 minutes of robotic intervention training per session, for a total of 80 sessions.
- DeviceTranscutaneous Lumbosacral Stimulation (TLS)
EAW+TLS. This group will receive 60 minutes of exoskeleton assisted overground walking with simultaneous Transcutaneous Lumbosacral Stimulation (TLS) followed by 15 minutes of overground training without exoskeleton.
Location
- Kessler FoundationWest Orange, New Jersey