Pelvic Floor Rehabilitation in Females With Multiple Sclerosis: Comparison of Two Telerehabilitation Protocols

CompletedNot a drug-phase studyRelapsing MSNCT05984095

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Telerehabilitation

What it measured

Main measures

  • Pain perception

    At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)

    Pain
  • Depression symptoms

    At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)

    Mood and sleep
  • Perceived quality of life

    At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)

    Quality of life (reported by participants)
  • Sexual health

    At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)

    Bladder, bowel and sexual function
  • Urinary incontinence symptoms

    At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)

    Bladder, bowel and sexual function

Who could take part

Relapsing MS · 18 to 50

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Sept 2023

    2. Main results due

      Nov 2023

    3. Finished

      Nov 2023

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