Clinical trial NCT05984095: Multiple Sclerosis Pelvic Floor Telerehabilitation
Official title: Pelvic Floor Rehabilitation in Females With Multiple Sclerosis: Comparison of Two Telerehabilitation Protocols
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Pelvic Floor
Telerehabilitation
Exercise
Lead sponsor: University of Trieste
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pain perception
timeFrame: At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)
measure: Depression symptoms
timeFrame: At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)
measure: Perceived quality of life
timeFrame: At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)
measure: Sexual health
timeFrame: At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)
measure: Urinary incontinence symptoms
timeFrame: At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)
Secondary outcomes:
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: CdL in Fisioterapia
Study officials:
affiliation: University of Trieste
name: Paolo Manganotti, MD PhD
role: STUDY_CHAIR
References: