Efficacy of a Face-to-face Versus a Remote Physiotherapy Instruction Session About Pelvic Floor in the Pelvic Floor Muscle Capacity of Incontinent Women: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Change in self-perception of the PFM
研究概览
简要总结
The purpose of this study is to assess and to compare the efficacy of a face to face versus a remote physiotherapy instruction session about pelvic floor muscle (PFM) function, including teaching women how to contract their PFM and how to perceive a correct PFM contraction. Study participants will be randomly assigned to participate in one of the three study groups: Group 1 will receive face to face instructions, Group 2 will receive real time remote instructions and Group 3 will not receive any instruction. The primary outcome measure is PFM function assessed using the modified Oxford Scale.
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)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women who are not able to contract their PFM (≤ 2 of Modified Oxford Scale);
- •Cognitive ability, hearing and visual acuity preserved (through 10-point cognitive screener and Snellen test, respectively);
- •Non-neurogenic UI;
- •No history of neurological disorders;
- •No symptoms of a vaginal or urinary tract infection;
- •Pelvic organ prolapse ≤2 (according to the Baden and Walker scale);
- •Who have not already been instructed on how to perform PFM contraction or who is not already performing PFM training;
- •No suspected or confirmed pregnancy.
排除标准
- •Who have intolerance to physical examination, or latex allergy;
- •Who withdraws from participating in the study.
研究组 & 干预措施
Face to face intervention group
This group will be composed of participants who will receive face to face physiotherapy instruction session.
干预措施: Face to face intervention group (Other)
Remote intervention group
This group will be composed of participants who will receive real time remote physiotherapy instruction session.
干预措施: Remote intervention group (Other)
Control group
This group will be composed of participants who will not receive any type of physiotherapy instruction session during the period of the study.
干预措施: Control group (Other)
结局指标
主要结局
Change in self-perception of the PFM
时间窗: At baseline, immediately after intervention and 20 days after the intervention.
The Modified Oxford Scale will be used to assess change in the participants' self-perception of their contraction after vaginal palpation. The Modified Oxford Scale is a categorical variable with 6 possible answers ranging from 0 to 5. High scores of Modified Oxford Scale mean better PFM function and lower scores mean worse PFM function.
Change in contraction capacity
时间窗: At baseline, immediately after intervention and 20 days after the intervention.
The Modified Oxford Scale will be used to assess change in the capacity to perform a PFM contraction through vaginal palpation. The Modified Oxford Scale is a categorical variable with 6 possible answers ranging from 0 to 5. High scores of Modified Oxford Scale mean better PFM function and lower scores mean worse PFM function.
次要结局
- System usability assessment(Immediately after intervention)
- Satisfaction with the orientations(Immediately after intervention)
- Self-report of UI symptoms(At baseline and 20 days after the intervention.)
- Assessment of the usefulness of teaching resources(Immediately after intervention)
研究者
Caroline Caetano Pena
Principal investigator
University of Sao Paulo