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Multiple Sclerosis Pelvic Floor Telerehabilitation

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Telerehabilitation
Sponsored by
University of Trieste
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Pelvic Floor, Telerehabilitation, Exercise

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • CdL in FisioterapiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

SELF

REMOTE

Arm 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.

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.

Outcomes

Primary Outcome Measures

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
Depression symptoms
Evaluation of depression symptoms with the Beck Depression Inventory Scale (BDI, 0-63, higher the score worse the depression)
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)
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)
Urinary incontinence symptoms
Evaluation of urinary incontinence symptoms with the International Consultation on Incontinence Questionnaire (ICIQ, 0-21, higher the score worse the symptoms)

Secondary Outcome Measures

Full Information

First Posted
August 1, 2023
Last Updated
October 18, 2023
Sponsor
University of Trieste
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1. Study Identification

Unique Protocol Identification Number
NCT05984095
Brief Title
Multiple Sclerosis Pelvic Floor Telerehabilitation
Official Title
Pelvic Floor Rehabilitation in Females With Multiple Sclerosis: Comparison of Two Telerehabilitation Protocols
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2023 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
November 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Trieste

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Pelvic Floor, Telerehabilitation, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The investigator in charge of reviewing the questionnaires and calculating the scores was not informed about the group of the participant.
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SELF
Arm Type
Active Comparator
Arm 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.
Arm Title
REMOTE
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Telerehabilitation
Intervention Description
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 Outcome Measure Information:
Title
Pain perception
Description
Quantification of the perceived pain with a numeric rating scale (NRS, score 0-10 where 10 means unbearable plain), and a body chart
Time Frame
At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)
Title
Depression symptoms
Description
Evaluation of depression symptoms with the Beck Depression Inventory Scale (BDI, 0-63, higher the score worse the depression)
Time Frame
At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)
Title
Perceived quality of life
Description
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)
Time Frame
At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)
Title
Sexual health
Description
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)
Time Frame
At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)
Title
Urinary incontinence symptoms
Description
Evaluation of urinary incontinence symptoms with the International Consultation on Incontinence Questionnaire (ICIQ, 0-21, higher the score worse the symptoms)
Time Frame
At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manuela Deodato, PT PhD
Phone
040/3996584
Email
mdeodato@units.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Manganotti, MD PhD
Organizational Affiliation
University of Trieste
Official's Role
Study Chair
Facility Information:
Facility Name
CdL in Fisioterapia
City
Trieste
ZIP/Postal Code
34100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuela Deodato, PT PhD
Phone
040/3996584
Email
mdeodato@units.it
First Name & Middle Initial & Last Name & Degree
Manuela Deodato, PT PhD
First Name & Middle Initial & Last Name & Degree
Paolo Manganotti, MD PhD
First Name & Middle Initial & Last Name & Degree
Arianna Sartori, MD
First Name & Middle Initial & Last Name & Degree
Mia Fornasaro, PT student

12. IPD Sharing Statement

Plan to Share IPD
No

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Multiple Sclerosis Pelvic Floor Telerehabilitation

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