An observational study in Spinal Cord Injuries and Incomplete Spinal Cord Injury, sponsored by Kessler Foundation. Status unknown at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-17.
Sponsored by Kessler Foundation · Observational
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 optimal effects, the NMES interventions that involve or promote voluntary efforts from SCI participants are preferred. However, these interventions are limited by the fact that the active monitoring of voluntary effort, particularly at the stimulated muscle level is unattainable. The objective of the proposed study is to develop SMARTq (Stimulated Muscle Assessment in Real-Time). This novel system will provide a quasi real-time assessment of intrinsic neuromuscular responses of a stimulated muscle during NMES. Specifically, the proposed system will consist of our novel algorithms interfaced with the EMG data acquisition hardware to process the EMG data recorded from a stimulated muscle in real-time during NMES. The term 'quasi' is used to account for the processing delay of approximately 1 to 2 seconds that may potentially occur. The proposed system will be developed and validated using the data collected from the able-bodied (AB) as well as individuals with incomplete SCI (iSCI). The applicability of the system will be evaluated on individuals with complete SCI (cSCI). Our central hypothesis is that the real-time tracking of neuromuscular responses during a train of NMES will provide valuable information on inherent neuromuscular changes, volitional participation, and neuromuscular recovery. The significance of the proposed study is that, if successful, it will deliver a highly novel system which can allow researchers and clinicians to - 1) evaluate the direct electrophysiological effects of varied combination of NMES on a stimulated muscle in real-time; 2) quantify, track and manipulate the levels of voluntary efforts or volitional drive 'on-fly' during NMES for extracting optimal benefits; 3) track the neuromuscular recovery of the stimulated muscle, particularly for cSCI populations, when any functional changes have not been observed yet; and 4) directly observe the neuromuscular fatigue derived from the electrophysiological data at the stimulated muscle. These are highly significant opportunities that can allow the clinicians and researchers to transform the current as well as future NMES interventions into highly effective training modalities as each intervention will be operated at an individual's neuromuscular level.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's planned enrollment of 15 is below the median of 60 across 323 observational studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Kessler Foundation is the lead sponsor of 170 studies on the registry; 58 are open to participants now.
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There will be five participants in each of the three study groups: able-bodied (AB), incomplete spinal cord injury (iSCI), and complete spinal cord injury (cSCI). All participants will be between the ages of 18 and 60 years old. Individuals will be recruited through the Kessler Institute for Rehabilitation System, which includes 3 hospitals and 75 outpatient clinics.
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 Criteria:
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.
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. Additional - 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.
1) Be chronic (≥ 1-year post injury); 2) AIS classified as A or B motor-complete; Additional - 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.
1) Be able and willing to tolerate electrical stimulation; 2) Be able and willing to comply with study requirements, procedures and verbal instructions.
Electromyography (EMG) correlates
EMG RMS amplitude,
Time frame: A single timepoint
Torque
Torque recorded at knee joint using biodex dynamometer
Time frame: A single timepoint
RMSE
RMSE between EMG feedback vs torque feedback
Time frame: single timepoint
Plan to share: Undecided — as per the funding agency guidelines.
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Kessler Foundation