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Spinal cord injury (SCI) can make it hard for the body to self-regulate some of its automatic functions like blood pressure, breathing, and heart rate. This can also make it hard for those living with SCI to exercise or complete their usual daily activities. The goal of this randomized trial is to test combinatory therapy of moderate arm-crank exercise paired with non-invasive transcutaneous spinal cord stimulation (tSCS) for cardiovascular recovery in adults aged 21-65 following chronic motor-complete spinal cord injury (SCI) at or above the thoracic sixth spinal segment (≥T6).
The main questions the study aims to answer are:
Participants will:
Researchers will compare those who receive tSCS and do moderate arm-crank exercise to those who receive a sham stimulation and do moderate arm-crank exercise to see if tSCS is effective at improving cardiovascular and autonomic functioning in those with SCI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tSCS paired with arm-crank exercise | Experimental | Device: Transcutaneous Spinal Stimulation Non-invasive electrical stimulation of the spinal cord over the skin. Other: Arm-crank exercise Exercise using an arm-bike to target cardiovascular functioning. |
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| Sham stimulation paired with arm-crank exercise | Sham Comparator | Device: Sham Stimulation Non-invasive electrical stimulation of a lower extremity muscle group over the skin. Other: Arm-crank exercise Exercise using an arm-bike to target cardiovascular functioning. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Spinal Cord Stimulation | Device | Non-invasive electrical stimulation of the spinal cord over the skin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in systolic Blood Pressure (BP) from baseline. | Continuous beat-by-beat BP will be measured using a finger photoplethysmography. | Baseline |
| Change in systolic Blood Pressure during a sit-up test or head-up tilt test. | Continuous beat-by-beat BP will be measured during a orthostatic challenge. | Repeated measurements before and after each 8 week-intervention block, an average of 6 months |
| Heart rate variability recorded by electrocardiogram (ECG). | Parameters using RR intervals (R-wave peak to R-wave peak in electrocardiogram) processed to assess the activity of autonomic nervous system. | Repeated measurements before and after each 8 week-intervention block, an average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Peak oxygen uptake (VO2peak) | Measured during incremental cardiopulmonary exercise test (CPET) on the arm-crank. | Repeated measurements before and after each 8 week-intervention block, an average of 6 months |
| Autonomic dysfunction following Spinal Cord Injury (ADFSCI) measure |
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Inclusion Criteria:
Are between 21-65 years of age.
Chronic SCI (non-progressive, with complete motor paralysis) at or above the T6 spinal cord segment.
Greater than ten months post injury or diagnosis, at least 6 months from any spinal surgery.
American Spinal Injury Association Impairment Scale (AIS) A, B for SCI.
Have stable medical condition without cardiopulmonary disease that would contraindicate participation in intensive training or testing activities.
Cleared for strenuous exercise with arm bike by a primary physician of the subject (the clearance for intensive training with arm bike is obtained verbally or through a written form by a primary physician.)
Willing and able to comply with all clinic visits and study-related procedures.
Able to understand and complete study-related questionnaires (must be able to understand and speak English or have access to an appropriate interpreter as judged by the investigator).
Have no painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing.
Are with stable management of spinal cord related clinical issues (i.e., spasticity management).
Women of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:
-----Women of childbearing potential must agree to use adequate contraception during the period of the trial and for at least 28 days after completion of treatment. Effective contraception includes abstinence.
Sexually active males with female partners of childbearing potential must agree to use effective contraception during the period of the trial and for at least 28 days after completion of treatment.
Are volunteering to be involved in this study.
Has adequate social support to be able to participate in training and assessment sessions, up to 3 sessions per week, for the duration of up to 6 months within the study period.
Must provide informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Soshi Samejima, DPT, PhD | Contact | 2066160462 | soshis@uw.edu | |
| Katie Singsank | Contact | 2065430110 | singsank@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Soshi Samejima, DPT, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Recruiting | Seattle | Washington | 98195 | United States |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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randomized, single-blind, sham-controlled trial with two arms (tSCS paired with arm-crank exercise compared to sham stimulation with exercise). Participants will be randomized into either the intervention or sham stimulation arm. Those in the sham arm only will initially receive sham stimulation, but then cross over to receive the active treatment arm, such that by the end all participants will have been exposed to the tSCS. tSCS participants will not receive sham stimulation.
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| Arm-crank bike exercise | Behavioral | Exercise using an arm-bike to target cardiovascular functioning. |
|
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| Sham Stimulation | Other | Non-invasive electrical stimulation of a lower extremity muscle group over the skin. |
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The Autonomic Dysfunction following SCI (ADFSCI) measure will be used to assess severity and frequency of autonomic dysreflexia. Greater scores equal greater frequency of autonomic dysfunction, ranging from 0 (never) to 4 (very often) for each item. |
| Repeated measurements before and after each 8 week-intervention block, an average of 6 months |
| International Standards for Neurological Classification of Spinal Cord Injury | level and severity of damage to motor and sensory pathways will be determined by trained clinicians. Pin prick and light touch will be done by researchers on participant's left and right side. Check marks are given for each prick or touch that is felt by the participant, then tallied. Scores range from 0-56 for both the Left and Right side of the body, and 0-112 for the total score. High scores represent greater sensory functioning. | Repeated measurements before and after each 8 week-intervention block, an average of 6 months |
| International Standards to document remaining Autonomic Function after Spinal Cord Injury (ISAFSCI) | Scores for questions on the ISAFSCI range from 0 to 2, with 0 representing complete loss of control and 2 representing normal functioning. Lower scores equal worse health functioning. | Repeated measurements before and after each 8 week-intervention block, an average of 6 months |
| Blood Pressure variability | BP Variability will be assessed using results from continuous beat-by-beat BP measurements obtained throughout the study using Finapres NOVA and a 24 hour BP monitoring assessment. | Repeated measurements before and after each 8 week-intervention block, an average of 6 months |
| Change from baseline- Graded Redefined Assessment of Strength, Sensation, and Prehension version 2 | Measurement of upper limb strength, sensation, qualitative prehension, and quantitative prehension (range 0-188, higher score mean better outcome) | Repeated measurements before and after each 8 week-intervention block, an average of 6 months |
| Change from baseline- Capabilities of Upper Extremity Test | Measures unilateral and bilateral hand and arm function (range 0-128, higher score mean better outcome) | Repeated measurements before and after each 8 week-intervention block, an average of 6 months |
| International Spinal Cord Injury Pain Basic Dataset version 2.0 | Standardized questionnaire for the collection and reporting of pain in the SCI population. Scores range from 0 to 10, with higher scores indicating greater pain interference and worse functioning. | Repeated measurements before and after each 8 week-intervention block, an average of 6 months |
| International Spinal Cord Injury Lower Urinary Tract Function Dataset | The International SCI Lower Urinary Tract Function Dataset is a data collection form for the collection and reporting of lower urinary tract function in the SCI population. Participants are asked to mark either main or supplementary for type of bladder emptying, and then answer yes or no questions regarding type of appliances used to collect urinary incontinence, drugs with possible influence on urinary tract within the past 4 weeks, and any surgical procedures on the urinary tract. This data collection form does not use numbers and instead collects qualitative data only; there is no score range. | Repeated measurements before and after each 8 week-intervention block, an average of 6 months |
| International Spinal Cord Injury Bowel Function Dataset | Standardized data collection form for the collection and reporting of bowel function in the SCI population. The International SCI Bowel Function Dataset is a data collection instrument that asks participants qualitative questions which are assigned a score. Select items are then totaled to compute the Neurogenic Bowel Dysfunction (NBD) score. Scores range from 0 to 14 or more, with higher scores indicating greater neurogenic bowel dysfunction. | Repeated measurements before and after each 8 week-intervention block, an average of 6 months |
| D014947 | Wounds and Injuries |