Changes in Pelvic Floor Function With Tibial Neuromodulation Combined With Standing Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Pelvic Floor Muscle Reflex Excitability
研究概览
简要总结
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:
- What is the modulatory role of load and posture on reflex activation of the pelvic floor muscles in participants with SCI?
- What is the feasibility of combining tibial neuromodulation with standing therapy in participants with SCI?
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Standing + Tibial Nerve Stimulation
干预措施: Standing + Tibial Nerve Stimulation (Behavioral)
结局指标
主要结局
Pelvic Floor Muscle Reflex Excitability
时间窗: 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.
次要结局
- Feasibility - Recruitment Rate(Through study completion, an average of 8 months)
- Feasibility - Adherence(Through study completion, an average of 8 months)
- Feasibility - Adverse Events(Through study completion, an average of 8 months)
- Acceptability(Through study completion, an average of 3 months)
- Neurogenic Bladder Symptoms Score (NBSS)(Through study completion, an average of 8 months)
- Incontinence Quality of Life Questionnaire (I-QoL)(Through study completion, an average of 8 months)
研究者
Tania Lam
Professor
University of British Columbia