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| Name | Class |
|---|---|
| The Craig H. Neilsen Foundation | OTHER |
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The goal of this clinical trial is to understand how sensory inputs from the lower leg can influence pelvic floor muscle function and urogential function in adults with chronic spinal cord injury (SCI). The main questions it aims to answer are:
Participants will be asked complete a series of assessments (questionnaires, electrophysiological testing) before and after a 12-week intervention of combined standing and tibial nerve stimulation therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standing + Tibial Nerve Stimulation | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standing + Tibial Nerve Stimulation | Behavioral | Standing (with the support of a standing frame) combined with transcutaneous tibial nerve stimulation 3x/week for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pelvic Floor Muscle Reflex Excitability | We will electrically stimulate the tibial nerve and record reflexes responses from the pelvic floor muscles using perianal surface electromyography. We will examine the amplitude of the reflex response. | At baseline to within 2 weeks of completing the study intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility - Recruitment Rate | Recruitment rate will be evaluated by number of participants approached, screened for eligibility, as well as reasons for exclusions. | Through study completion, an average of 8 months |
| Feasibility - Adherence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yao Sun, PhD | Contact | 604-675-8815 | lamlab@icord.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICORD | Recruiting | Vancouver | British Columbia | V5Z 1M0 | Canada |
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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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| ID | Term |
|---|---|
| D000078783 | Standing Position |
| ID | Term |
|---|---|
| D011187 | Posture |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Adherence will be tracked by the compliance of participants to the intervention, with reasons for missed sessions or drop-outs noted.
| Through study completion, an average of 8 months |
| Feasibility - Adverse Events | Any adverse events to study protocols will be recorded. | Through study completion, an average of 8 months |
| Acceptability | The acceptability of the intervention will be evaluated using a 7-point Likert scale to rate participants' opinions about the intervention (enjoyment and perceived benefits) and the outcome measures (tolerability and appropriateness of the measurement procedures). A higher score indicates a more acceptable intervention. | Through study completion, an average of 3 months |
| Neurogenic Bladder Symptoms Score (NBSS) | Participants will be asked to respond to 24 questions regarding the severity of their bladder symptoms secondary to neurological injury. Questions cover three subdomains: incontinence, storage and voiding, and consequences. The total score on this questionnaire ranges from 0-74, where a lower score represents less severe symptoms. | Through study completion, an average of 8 months |
| Incontinence Quality of Life Questionnaire (I-QoL) | Participants will be asked to respond to 22 questions about how urinary incontinence impacts their quality of life using a 5-point scale with values ranging from 1 (extremely) to 5 (not at all). The questionnaire probes three subdomains of how incontinence may affect quality of life: avoidance and limiting behavior, psychosocial impact, and social embarrassment. Total score on this questionnaire ranges from 0-100, where a higher score represents higher quality of life. | Through study completion, an average of 8 months |
| D014947 | Wounds and Injuries |