Spinal Cord Injury Cervical Clinical Trial
Official title:
Effect of Electrode Placement on Controlling Orthostatic Hypotension in People With Cervical Spinal Cord Injury
Verified date | January 2024 |
Source | Quality Living, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A common therapeutic intervention after spinal cord injury (SCI) is prolonged standing in a standing frame. For people with SCI, standing for 40 minutes or more, three to four times weekly improves several health-related issues including well-being, circulation, skin integrity, reflex activity, bowel and bladder function, digestion, sleep, pain, and fatigue. However, a person who experiences orthostatic hypotension (OH)-defined as a decrease of 20mm hg in systolic blood pressure or a decrease of 10mm hg in diastolic pressure within 3 minutes of standing from a sitting or supine position-secondary to SCI may not tolerate positioning in a standing frame, thus resulting in a loss of access to these health benefits. OH is common for people with SCI. It results from central nervous system dysregulation causing pooling of blood in the lower extremities that can lead to dizziness, light-headedness, blurred vision, weakness, fatigue, nausea, palpitations, headache, and/or syncope. Although an array of physical and pharmacologic interventions are available to people in the general population for managing OH, few such interventions have been evaluated for use by people with SCI, especially when the level of injury is C5 or above. One possible intervention that may be effective for people with OH secondary to SCI is functional electrical stimulation (FES) because its application results in a dose-dependent increase in blood pressure. An unanswered question is whether the placement of FES electrodes on various parts of the body has differential effects. Therefore, the purpose of this study is to evaluate blood pressure responses among people with OH secondary to cervical SCI when receiving FES intervention involving the placement of electrodes in three different positions as well as when receiving no FES intervention during tilt table sessions. The selected positions for electrode placement are: (a) the calves, (b) the quads and abdominals, and (c) the quads, abdominals, and calves. The researchers hypothesize that FES intervention, regardless of placement, will result in better control of OH than no FES intervention and that no significant blood pressure difference will occur across the three FES placements.
Status | Enrolling by invitation |
Enrollment | 10 |
Est. completion date | April 30, 2024 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 70 Years |
Eligibility | Inclusion Criteria: - adult resident of Quality Living, Inc. - SCI at the level of C5 or higher - experience OH upon rising from a sitting or supine position - comprehend English sufficiently to understand the consent form as measured by responses to included questions Exclusion Criteria: - any person who has a legally authorized representative responsible for making healthcare decisions because of compromised cognitive or communication status - any person for whom FES is contraindicated as determined by the physiatrist responsible for monitoring the health and rehabilitation programs of Quality Living residents |
Country | Name | City | State |
---|---|---|---|
United States | Quality Living, Inc. | Omaha | Nebraska |
Lead Sponsor | Collaborator |
---|---|
Quality Living, Inc. |
United States,
Chi L, Masani K, Miyatani M, Adam Thrasher T, Wayne Johnston K, Mardimae A, Kessler C, Fisher JA, Popovic MR. Cardiovascular response to functional electrical stimulation and dynamic tilt table therapy to improve orthostatic tolerance. J Electromyogr Kinesiol. 2008 Dec;18(6):900-7. doi: 10.1016/j.jelekin.2008.08.007. Epub 2008 Oct 2. — View Citation
Eng JJ, Levins SM, Townson AF, Mah-Jones D, Bremner J, Huston G. Use of prolonged standing for individuals with spinal cord injuries. Phys Ther. 2001 Aug;81(8):1392-9. doi: 10.1093/ptj/81.8.1392. — View Citation
Sampson EE, Burnham RS, Andrews BJ. Functional electrical stimulation effect on orthostatic hypotension after spinal cord injury. Arch Phys Med Rehabil. 2000 Feb;81(2):139-43. doi: 10.1016/s0003-9993(00)90131-x. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in tilt table angle from 0 degrees to maximum tolerated during session | Maximum tilt table angle, ranging from 0 to 90 degrees, tolerated by participant during each session | Measured over the course of each one hour tilt table session | |
Primary | Change in blood pressure from initial reading at start of each tilt table session | Systolic and diastolic blood pressure values measured in millimeters of mercury | Measured every three minutes throughout the time a participant is positioned on the tilt table |
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