Spinal Cord Injury Clinical Trial
Official title:
Exoskeleton and Spinal Cord Stimulation for SCI
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.
Status | Recruiting |
Enrollment | 24 |
Est. completion date | September 2025 |
Est. primary completion date | September 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 58 Years |
Eligibility | 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 21-58 years old; - have a spinal cord injury at a neurological level of injury as determined by study staff between C6-T-10; - be wheelchair reliant 100% of the time; - have knee bone mineral density great than .5755gm/cm2 as determined by study staff; - have a height between 62 inches to 74 inches. Exclusion Criteria: - have a history of broken or fractured bones. - have a history of bone trauma or bone disease. |
Country | Name | City | State |
---|---|---|---|
United States | Kessler Foundation | West Orange | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Kessler Foundation | Kessler Institute for Rehabilitation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | percent change in ariel mineral bone density. | Significant ariel bone mineral density | Baseline and immediately post intervention. | |
Other | percent change in volume metric and bone mineral density. | Significant ariel of volume metric and bone mineral density. | Baseline and immediately post intervention. | |
Other | percent change in bone strength and bone stiffness. | Significant ariel of bone strength and bone stiffness. | Baseline and immediately post intervention. | |
Primary | Percentage change 6-minute walk test (6MWT) | Participants undergoing EAW+TLS intervention will walk significantly further than those receiving EAW alone. | Measurements will be performed during the 28 weeks of training intervention after baseline. Training intervention is 28 weeks, 80 sessions total. Measurements will be performed after 20, 40, 60 and 80 sessions. | |
Primary | Percentage change 10 meter walk test (10MWT) | Participants undergoing EAW+TLS intervention will walk significantly faster than those receiving EAW alone training. | Measurements will be performed during the 28 weeks of training intervention after baseline. Training intervention is 28 weeks, 80 sessions total. Measurements will be performed after 20, 40, 60 and 80 sessions. | |
Secondary | Percentage change in scores on Berg Balance scale (BERG) | Participants undergoing EAW+TLS intervention will exhibit significantly greater improvements in standing balance than those receiving EAW alone training. | Measurements will be performed during the 28 weeks of training intervention after baseline. Training intervention is 28 weeks, 80 sessions total. Measurements will be performed after 20, 40, 60 and 80 sessions. | |
Secondary | Absolute change in the International Standards Examination | Participants undergoing EAW+TLS intervention will exhibit significantly greater improvements in lower extremity motor scores (LEMS) than those receiving EAW alone training. | Baseline and post intervention |
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