Status:
UNKNOWN
A Novel System for Quasi Real-Time Tracking of Neuromuscular Responses During NMES
Lead Sponsor:
Kessler Foundation
Collaborating Sponsors:
New Jersey Commission on Spinal Cord Research
Conditions:
Spinal Cord Injuries
Incomplete Spinal Cord Injury
Eligibility:
All Genders
18-60 years
Brief Summary
Neuromuscular electrical stimulation (NMES) remains as one of the effective rehabilitation modalities for addressing recovery of neuromuscular function after a spinal cord injury (SCI). To achieve opt...
Eligibility Criteria
Inclusion
- SCI generic criteria - 1) Be able to tolerate electrical stimulation; 2) Be able and willing to comply with study requirements, procedures and verbal instructions; 3) Have been diagnosed with a spinal cord injury by a physician.
- Individuals with complete SCI. 1) Be chronic (≥ 1-year post injury); 2) AIS classified as A or B motor-complete;
- Individuals with incomplete SCI. 1) Be motor incomplete; 2) Be AIS classified as C or D; 3) have a neurological level of injury from C6 - T6; 4) Have LEMS score \> 10; 5) Have Modified Ashworth Scale ≤ 3 for spasticity.
- Inclusion criteria for the able-bodied group. 1) Be able and willing to tolerate electrical stimulation; 2) Be able and willing to comply with study requirements, procedures and verbal instructions.
Exclusion
- Exclusion criteria for all participants. 1) Pregnancy at time of study; 2) History of femur or tibia fracture; 3) Diagnosis with any major cardiovascular or pulmonary disease; 4) Diagnosis with obesity; 5) Diagnosis of lower extremity deep vein thrombosis; 6) Presence of skin lesions or breakdown; 7) Use of electronic implants; 8) Any history of major gastrointestinal problems; 9) difficulty following or responding to commands that would limit the study participation; 10) Currently enrolled in another research study or therapy (from a licensed physical therapist) that is likely to affect participation in this research study.
Key Trial Info
Start Date :
December 9 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05243576
Start Date
December 9 2019
End Date
December 1 2022
Last Update
February 17 2022
Active Locations (1)
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1
Kessler Foundation
West Orange, New Jersey, United States, 07052