Multiple Sclerosis Pelvic Floor Telerehabilitation

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Telerehabilitation

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Trieste, Italy, 34100
    • CdL in Fisioterapia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SELF; 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.	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.
Experimental: REMOTE; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: University of Trieste
• Investigators: Study Chair: Paolo Manganotti, MD PhD, University of Trieste

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Actual): November 15, 2023
• Study Completion (Actual): November 25, 2023

Study Registration Dates

• First Submitted: August 1, 2023
• First Submitted That Met QC Criteria: August 1, 2023
• First Posted (Actual): August 9, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 26, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Exercise; Telerehabilitation; Pelvic Floor
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: Fisioterapia1907

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No