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NCT Number: NCT05984095

Multiple Sclerosis Pelvic Floor Telerehabilitation

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Motor Activity Nervous System Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CdL in Fisioterapia

Trieste, 34100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

telerehabilitation

Other

The intervention was administered in a telerehabilitation fashion through a videocall on the phone or tablet, by a physiotherapist, in a one-to-one session.

Primary outcomes

  1. Pain perception

    Time frame: 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

  2. Depression symptoms

    Time frame: 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)

  3. Perceived quality of life

    Time frame: 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)

  4. Sexual health

    Time frame: 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)

  5. Urinary incontinence symptoms

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Trieste

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 9, 2023
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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