Functional Electrical Stimulation vs Transcutaneous Stimulation in Patients With Subacute Spinal Cord Injury

RTI Xcite

Functional electrical stimulation

ExaStim

Transcutaneous spinal stimulation

A performance measure focused on quantifying upper limb limitations and impairment. The CUE-T assesses 17-19 tasks including reaching, lifting (up to 2kg), wheelchair push up, dynamometer strength testing, and active range of motion. Scoring is scored from 0 (unable) to 4 (no difficulty) with high scores indicating better upper limb function. This measure will be completed by a study staff (licensed physical or occupational therapist) who is blinded to treatment allocation. This instrument typically requires 15-30 minutes to complete. CUE-T evaluation sessions will be video-recorded so that observations of participant activities can be validated for study purposes. These video recordings will be destroyed as soon as the CUE-T assessment score has been finalized (within 2 weeks of completing the CUE-T.)

The UEMS is an upper limb strength assessment of upper limb muscles stratified by spinal nerve level innervation, using traditional manual muscle testing scoring (0-5/5). This requires the participant to demonstrate available movement against gravity, then if full movement is available that motion could be tested against resistance of the tester. If unable to move against gravity the muscles would be tested in gravity eliminated position (ie., horizontal plane) for active range of motion for full/partial range or palpable activity of the targeted muscle group. These tests are consistent with clinical practice to assess spinal cord injury level. This subscale may be performed by the blinded assessor if not completed by clinical staff as part of the ASIA Impairment Scale/International Standards for Neurological Classification of Spinal Cord Injury (AIS/ISNCSCI).

This is an impairment scale to measure muscle spasticity or tone in response to passive lengthening of a muscle. It requires the participant to lay supine while study staff, the blinded assessor/therapist, passively moves a joint to lengthen a muscle over a joint's full range of motion over approximately 1 second, or approximately at the speed of gravity. Each joint/muscle tested may be tested up to three times. The scale rates resistance to passive movement from 0 (no increase in tone) to 4 (joint fixed in flexion or extension). For this study, only the upper limb will be tested as part of the protocol.

The CUE-Q is a 32-item questionnaire that evaluates functional limitations of the hands and arms using a scale of perceived difficulty from 0 (unable) - 4 (no difficulty). Activities inquired about include reaching, lifting objects, pulling/sliding objects, holding small objects like coins, etc. This may take 5-15 minutes to administer.

This assessment is designed solely for use during inpatient rehabilitation; it replaced the previous use of the FIM measure for inpatient rehabilitation. For this outcome, assessments will be completed by VA clinical therapist(s) who will categorize typical function over a 3-day admission period and during the final three days prior to discharge. This assessment categorizes functional level from 01 (dependent) to 6 (independent). For this study, this assessment will be completed as a portion of clinical assessment, and will include observation of specific functional activities as deemed appropriate & safe for clinical assessment including but not limited to: Self-care (upper body dressing, bathing,, toileting, oral hygiene, eating, etc), mobility ((rolling, sit to lying, lying to sitting edge of bed, sit to stand, chair to chair transfer, toilet transfer, walking various distances, stairs, wheeled mobility, etc), bowel and bladder continence, and health history (falls, pain, etc).

Promis Pain Intensity and Interference scales are short form assessments using a Likert scale addressing levels of pain or pain interference from 1 (not at all/never) - 7 (very much/always). These scales would take less than 10 minutes to complete.

This assessment focused on measuring quality of life (QOL) across physical, emotional and global health domains using a Likert scale with ratings from 1 (lowest frequency, or never) to 5 (highest frequency or always). This scale is sometimes called the NeuroQOL, and has been updated to be structured like the PROMIS measures where it can be completed via paper forms, short forms, or a computer adaptive testing on a tool such as REDcap. The adaptive testing can take as little as 10 minutes and provides a T-score across a normalized scoring distribution of 100, where the mean is 50.