Spinal Cord Injury
Conditions
Keywords
Spinal Cord Injury, Nerve Stimulation, Standing, Pelvic Floor
Brief summary
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.
Interventions
BEHAVIORALStanding + Tibial Nerve Stimulation
Standing (with the support of a standing frame) combined with transcutaneous tibial nerve stimulation 3x/week for 12 weeks.
Sponsors
University of British Columbia
The Craig H. Neilsen Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 19 years of age * Have a SCI between C7 - T10 that occurred at least 12 months previously * Have a motor-complete or incomplete SCI (AIS A, B, C, or D) * Have symptoms of neurogenic LUT dysfunction * Meet the manufacture requirements for standing frame use (will be evaluated by the research team) * Are able to speak and understand English.
Exclusion criteria
* Have changed their bladder management program in the past month * Have received an injection of Botulinum toxin-A in any LUT structure in the past 2 weeks, or intend to receive an injection while participating in the trial * Have a non-stable SCI (e.g. spinal tumor) * Have signs of a lower motoneuron injury (e.g. cauda equina syndrome) * Have other neurological injury besides SCI * Have an implanted metallic or electronic device (e.g. pace maker, nerve stimulator) * Have a condition for which exercise or transcutaneous stimulation is contraindicated * Have a severe acute medical issue that in the investigator's judgement would adversely affect the participant's participation in the study. Examples include, but are not limited to acute urinary tract infections, pressure sores, musculoskeletal injury, or unmanage blood pressure. * Are currently pregnant or have given birth within the past 12 months * Use walking as your primary means of movement around your home and the community.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic Floor Muscle Reflex Excitability | At baseline to within 2 weeks of completing the study intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - Recruitment Rate | Through study completion, an average of 8 months | Recruitment rate will be evaluated by number of participants approached, screened for eligibility, as well as reasons for exclusions. |
| Feasibility - Adherence | Through study completion, an average of 8 months | Adherence will be tracked by the compliance of participants to the intervention, with reasons for missed sessions or drop-outs noted. |
| Feasibility - Adverse Events | Through study completion, an average of 8 months | Any adverse events to study protocols will be recorded. |
| Acceptability | Through study completion, an average of 3 months | 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. |
| Neurogenic Bladder Symptoms Score (NBSS) | Through study completion, an average of 8 months | 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. |
| Incontinence Quality of Life Questionnaire (I-QoL) | Through study completion, an average of 8 months | 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. |
Countries
Canada
Contacts
CONTACTYao Sun, PhD
Outcome results
None listed