The purpose of the current study is to evaluate whether a home-based, telehealth-supported intervention combining Blood Flow Restricted Exercise (BES) and Transspinal Stimulation (TS) will improve motor and functional abilities greater than BES+sham TS in persons with chronic, incomplete tetraplegia.
Cervical spinal cord injury (cSCI) results in physical impairment and limited mobility, with the most severe cSCI necessitating wheelchair use for ambulation and impaired upper extremity function resulting in subsequent chronic comorbidities. These comorbidities may include psychosocial, cardiovascular, metabolic and respiratory consequences, as well as a significant socioeconomic burden. The economic burdens for persons with cSCI, their families, and society are increasing at an alarming rate, especially with decreasing mortality due to advances in medical interventions. Restoring some degree of upper extremity and hand function would improve overall functional ability and quality of life. Through physical rehabilitation, upper extremity function can improve, but gains are limited for people with the most severe, motor-complete cSCI. Attempts have been made to restore and improve upper extremity and hand function using implanted epidural stimulation of the cervical spinal cord, but alternatives to this invasive therapy are warranted to maximize the amount of people who may benefit from enhanced motor activation. The total study duration is 30 weeks. The first 4 weeks will start and end with baseline assessments (Baseline 1 \&2). The rest of this 4-week period will consist of 2 sessions/week of education and optimization provided to the participant and a caregiver, to instruct them to use the TS device and blood pressure machine and carry out massed practice training for both groups. The first two weeks of this 4-week phase will occur onsite in the laboratory, and the second two weeks of this 4-week phase will occur at home via telehealth to familiarize participants and companions with the telehealth platform - however, if the participant and companion desire more on-site instruction, they may come into the lab to do this during this time as well. Following the first 4-week phase, 16 weeks of 3 sessions/week of BES+TS or BES+sham TS training at home with supervision from the research team via telehealth will occur. In the week following completion of the intervention, post-intervention outcome measures assessments will take place. There will then be an 8-week washout period where participants will receive no training. Following the 8-week washout, participants will be asked to come back to the lab for one more follow-up assessment of outcome measures to test any long-term effects of the intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
44
Blood Flow Restriction Enhanced Neuromuscular Electrical Stimulation (BES) treatment plus transspinal stimulation (TS) plus repetitive practice of task-specific activities, also known as massed practice (MP)
Blood Flow Restriction Enhanced Neuromuscular Electrical Stimulation (BES) sham treatment plus transspinal stimulation (TS) plus repetitive practice of task-specific activities, also known as massed practice (MP)
Sheltering Arms Physical Rehabilitation Centers
Richmond, Virginia, United States
RECRUITINGRichmond VA Medical Center
Richmond, Virginia, United States
RECRUITINGVirginia Commonwealth University
Richmond, Virginia, United States
RECRUITINGChange in hand functional activities
The grasp and release test is a standardized test of functional activities depending on hand function in persons with cSCI. Participants will be asked to lift and move a peg, block, can, 1 lb. dumbbell weight and fork from lateral to medial over a 60 cm distance and release at midline.
Time frame: Baseline to 20 weeks
Change in maximum grip strength without TS
Using a standard hand-grip dynamometer, participants will be asked to squeeze the dynamometer with one hand at a time as strongly as possible for up to 3 seconds, to obtain a measure of the maximal voluntary force they can generate when closing their hand
Time frame: Baseline to 20 weeks
Change in maximum grip strength with TS
Using a standard hand-grip dynamometer, participants will be asked to squeeze the dynamometer with one hand at a time as strongly as possible for up to 3 seconds, to obtain a measure of the maximal voluntary force they can generate when closing their hand with the addition of TS over the skin targeting the cervical spinal cord
Time frame: Baseline to 20 weeks
Change in electrical activity activation with TS
During the assessment of maximal grip strength with TS, electromyography (EMG) will be used to measure the amount of neuromuscular electrical activation from the following muscle groups: wrist flexors, wrist extensors, elbow flexors, and elbow extensors.
Time frame: Baseline to 20 weeks
Change in EMG activation without TS
During the assessment of maximal grip strength without TS, electromyography (EMG) will be used to measure the amount of neuromuscular electrical activation: wrist flexors, wrist extensors, elbow flexors, and elbow extensors.
Time frame: Baseline to 20 weeks
Change in tactile perception
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The Semmes-Weinstein Monofilament Exam is used to assess cutaneous tactile perception in individuals with spinal cord injury to provide more precise assessment of sensory function. Semmes-Weinstein Monofilaments are small, thin fibers attached to a handle that bend once a certain amount of force (ranging from 0.07 - 300 grams) is applied. With eyes closed, participants will be asked whether they can feel a light touch from the monofilaments at standard locations on the palm and dorsum of the hand and fingers. Participants are given a score depending on what the thinnest filament and thus, what the smallest amount of force is which needs to be applied for them to perceive a tactile stimulus.
Time frame: Baseline to 20 weeks
Changes in capacity to perform functional activities
Functional activity will be measured using the Spinal Cord Injury-Functional Index Short Form (SCI-FI SF). The SCI-FI SF is a comprehensive measure of functional activity capacity for persons with SCI. It measures three subscales: Basic Mobility (9 items), Self-Care (9 items), and Fine Motor Function (8 items). Participants respond to item prompts using a Likert-type scale with anchors from 1 = "With much difficulty" to 4 = "Without any difficulty." Item scores for each subscale are summed and then converted to standardized T-scores, with higher scores reflecting greater functional capacity. We will use the tetraplegia-specific versions of the Self-Care and Fine Motor Function subscales.
Time frame: Baseline to 20 weeks
Change in vital capacity
Forced vital capacity is an evaluation of how much air a person can forcefully exhale after a maximal inspiratory effort. Tests are conducted using a digital spirometer or respiratory monitor. Participants will be asked to seal their lips around a disposable mouthpiece connected to the respiratory monitor via an anti-viral/anti-bacterial filter, then take a maximal inhalation immediately followed by a forceful exhalation which participants will be encouraged to maintain for as long as possible.
Time frame: Baseline to 20 weeks
Change in ventilatory muscle strength
Maximal inspiratory pressure and maximal expiratory pressure using a digital respiratory pressure meter are measures of ventilatory muscle strength. Participants will be asked to exhale fully, then seal their lips around a disposable mouthpiece and inhale as strongly as possible against an occlusion. They will be asked to inhale maximally and then exhale through a disposable mouthpiece against an occlusion.
Time frame: Baseline to 20 weeks
Change in heart rate variability
Tilt table test for heart rate variability will be used to assess changes in heart rate variability.
Time frame: Baseline to 20 weeks