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: 1. What is the modulatory role of load and posture on reflex activation of the pelvic floor muscles in participants with SCI? 2. What is the feasibility of combining tibial neuromodulation with standing therapy in participants with SCI? 3. What are the potential effects of combined tibial neuromodulation and standing therapy on reflex excitability and urogential symptoms and quality of life in people with SCI? 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Standing (with the support of a standing frame) combined with transcutaneous tibial nerve stimulation 3x/week for 12 weeks.
ICORD
Vancouver, British Columbia, Canada
RECRUITINGPelvic 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.
Time frame: At baseline to within 2 weeks of completing the study intervention
Feasibility - Recruitment Rate
Recruitment rate will be evaluated by number of participants approached, screened for eligibility, as well as reasons for exclusions.
Time frame: Through study completion, an average of 8 months
Feasibility - Adherence
Adherence will be tracked by the compliance of participants to the intervention, with reasons for missed sessions or drop-outs noted.
Time frame: Through study completion, an average of 8 months
Feasibility - Adverse Events
Any adverse events to study protocols will be recorded.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, an average of 8 months
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