Multiple Sclerosis Pelvic Floor Telerehabilitation

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05984095
• Other study ID #: Fisioterapia1907
• Status: Completed
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: November 25, 2023

Study information

• Verified date: November 2023
• Source: University of Trieste
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 25, 2023
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Telerehabilitation
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.

Locations

Country	Name	City	State
Italy	CdL in Fisioterapia	Trieste

Sponsors (1)

Lead Sponsor	Collaborator
University of Trieste

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain perception	Quantification of the perceived pain with a numeric rating scale (NRS, score 0-10 where 10 means unbearable plain), and a body chart	At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)
Primary	Depression symptoms	Evaluation of depression symptoms with the Beck Depression Inventory Scale (BDI, 0-63, higher the score worse the depression)	At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)
Primary	Perceived quality of life	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)	At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)
Primary	Sexual health	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)	At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)
Primary	Urinary incontinence symptoms	Evaluation of urinary incontinence symptoms with the International Consultation on Incontinence Questionnaire (ICIQ, 0-21, higher the score worse the symptoms)	At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)