Pelvic Floor Rehabilitation in Females With Multiple Sclerosis: Comparison of Two Telerehabilitation Protocols
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Perceived quality of life
研究概览
简要总结
The goal of this clinical trial is to compare the effects of two different pelvic floor telerehabilitation protocols on selected measures of quality of life and health in females with relapsing-remitting Multiple Sclerosis (rrMS). The main questions it aims to answer are:
- Is telerehabilitation sufficient to improve quality of life and health in females with rrMS, in particular dedicated to pelvic floor training?
- Are self-administered training protocols or remotely-supervised training protocols equally effective?
Participants will be randomized to two intervention groups: a self-administered training protocol (SELF) and a remotely-supervised (REMOTE) training protocol. Both protocols will consist in 10 sessions of pelvic floor training lasting 45 min each, once every 5 days.
At the start and at the end of the protocol, all participants will complete 6 questionnaires regarding pain, quality of life and health.
详细描述
In this study, the authors aim to evaluate the efficacy of two telerehabilitation protocols dedicated to pelvic floor and urogynecological health in females with relapsing-remitting Multiple Sclerosis (rrMS).
In particular, the included participants will be randomized to:
- SELF protocol: 10 sessions of pelvic floor exercises, self-administered with a set of videos where a physiotherapist showed the different exercises in order to complete a 45 minutes session.
- REMOTE protocol: 10 sessions of pelvic floor exercises, remotely conducted and supervised by a physiotherapist with a one-to-one videocall, showing and monitoring the exercises in order to complete a 45 minutes session.
One week before the first session and one week after the last session, all the participants will be asked to complete a set of surveys and questionnaires to investigate participants' pain perception, reported quality of life and health-related parameters.
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
The investigator in charge of reviewing the questionnaires and calculating the scores was not informed about the group of the participant.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •diagnosis of relapsing remitting Multiple Sclerosis confirmed by a neurologist and based on the McDonald criteria from not less than 1 y
- •EDSS <4.5
- •self reported symptoms of urinary incontinency
排除标准
- •females in menopause
- •previous history of bladder or urogynaecological surgery
- •previous history of major abdominal surgery
- •females with a delivery < 6 months from the start of the study
- •BMI > 30
结局指标
主要结局
Perceived quality of life
时间窗: At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)
Evaluation of the perceived quality of life with the Short Form Health Survey 36 (SF-36, 0-100 for each domain, higher the score better the quality of life)
Pain perception
时间窗: At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)
Quantification of the perceived pain with a numeric rating scale (NRS, score 0-10 where 10 means unbearable plain), and a body chart
Depression symptoms
时间窗: At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)
Evaluation of depression symptoms with the Beck Depression Inventory Scale (BDI, 0-63, higher the score worse the depression)
Sexual health
时间窗: At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)
Evaluation of the perceived sexual health with the female sexual function index (FSFI, 1-5 for each item, greater score indicating greater levels of sexual functioning)
Urinary incontinence symptoms
时间窗: At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)
Evaluation of urinary incontinence symptoms with the International Consultation on Incontinence Questionnaire (ICIQ, 0-21, higher the score worse the symptoms)
次要结局
未报告次要终点
研究者
Alex Buoite Stella
Research fellow
University of Trieste