Multiple Sclerosis Pelvic Floor Telerehabilitation

University of Trieste

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Other: Telerehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT05984095

Fisioterapia1907

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups

SELF

Active Comparator group

Description:

All the participants in the SELF group were asked to participate in 10 sessions of 45 minutes of pelvic floor training and exercises, once every 5 days. The exercises were available in pre-recorded videos and the participants were allowed to access it when and where they preferred, respecting the requested frequency. No supervision was provided during the trainings.

Treatment:

Other: Telerehabilitation

REMOTE

Experimental group

Description:

All the participants in the REMOTE group were asked to participate in 10 sessions of 45 minutes of pelvic floor training and exercises, once every 5 days. The exercises were shown and monitored remotely during a one-to-one videocall with a physiotherapist.

Treatment:

Other: Telerehabilitation