Effectiveness of Kinesio Taping on Neurogenic Bowel Dysfunction in Individuals With Spinal Cord Injury: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Defecation Frequency
研究概览
简要总结
Neurogenic bowel dysfunction is a common complication of spinal cord injury and may cause constipation, difficulty with defecation, prolonged bowel care, incomplete evacuation, fecal incontinence, and reduced quality of life. This randomized controlled trial aims to evaluate the effectiveness of Kinesio Taping added to a routine bowel management program in adults with spinal cord injury and upper motor neuron-type neurogenic bowel dysfunction.
Thirty participants will be randomly assigned to one of two parallel groups. The control group will receive a routine bowel management program, while the intervention group will receive Kinesio Taping in addition to the routine bowel management program. Kinesio Taping will be applied to the lower abdominal and lumbosacral regions three times per week for 4 weeks.
The primary outcome will be defecation frequency recorded using a 7-day bowel diary. Secondary outcomes will include stool consistency, defecation duration, perceived constipation severity, neurogenic bowel dysfunction severity, and health-related quality of life. Assessments will be performed before and after the 4-week intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessments will be performed by an investigator who is blinded to group allocation. Participants will be instructed not to disclose their treatment allocation to the outcome assessor.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older with traumatic or nontraumatic spinal cord injury
- •Neurological level of injury at T12 or above
- •Upper motor neuron-type neurogenic bowel dysfunction
- •Duration of spinal cord injury longer than 6 months
- •Ability and willingness to provide written informed consent
排除标准
- •Age younger than 18 years
- •Neurological level of injury below T12
- •Gastrointestinal disease diagnosed before the spinal cord injury, including irritable bowel syndrome or inflammatory bowel disease
- •History of conservative treatment for neurogenic bowel dysfunction within the previous 6 months
- •Colostomy or history of bowel surgery
- •Neurological disease other than spinal cord injury that may cause gastrointestinal or anal sphincter dysfunction
- •Cognitive impairment that may interfere with participation in the study
结局指标
主要结局
Change in Defecation Frequency
时间窗: Baseline and at the end of the 4-week intervention
Defecation frequency will be recorded using a 7-day bowel diary and expressed as the total number of defecations during a 7-day period. Higher values indicate more frequent bowel movements.
次要结局
- Change in Bristol Stool Form Scale Score(Baseline and at the end of the 4-week intervention)
- Change in Perceived Constipation Severity(Baseline and at the end of the 4-week intervention)
- Change in Neurogenic Bowel Dysfunction Score(Baseline and at the end of the 4-week intervention)
- Change in Short Form-36 Health Survey Scores(Baseline and at the end of the 4-week intervention)
- Change in Defecation Duration(Baseline and at the end of the 4-week intervention)
- Change in the Feeling of Complete Evacuation(Baseline and at the end of the 4-week intervention)
- Change in Straining During Defecation(Baseline and at the end of the 4-week intervention)
- Change in Painful Defecation(Baseline and at the end of the 4-week intervention)
研究者
Meltem Gunes Akinci
Assistant Professor
Pamukkale University