Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2025-12-24 @ 2:15 PM
Study NCT ID:
NCT05984095
Status:
COMPLETED
Last Update Posted:
2023-11-28
First Post:
2023-08-01
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multiple Sclerosis Pelvic Floor Telerehabilitation
Sponsor:
University of Trieste
Organization:
Study Overview
Official Title:
Pelvic Floor Rehabilitation in Females With Multiple Sclerosis: Comparison of Two Telerehabilitation Protocols
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: