Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2023-09-15
2023-11-25
Brief Summary
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* 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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* EDSS \<4.5
* self reported symptoms of urinary incontinency
Exclusion Criteria
* 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
18 Years
50 Years
FEMALE
No
Sponsors
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University of Trieste
OTHER
Responsible Party
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Alex Buoite Stella
Research fellow
Principal Investigators
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Paolo Manganotti, MD PhD
Role: STUDY_CHAIR
University of Trieste
Locations
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CdL in Fisioterapia
Trieste, , Italy
Countries
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References
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Deodato M, Fornasaro M, Martini M, Zelesnich F, Sartori A, Galmonte A, Buoite Stella A, Manganotti P. Comparison of different telerehabilitation protocols for urogenital symptoms in females with multiple sclerosis: a randomized controlled trial. Neurol Sci. 2024 Nov;45(11):5501-5509. doi: 10.1007/s10072-024-07742-y. Epub 2024 Sep 3.
Other Identifiers
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Fisioterapia1907
Identifier Type: -
Identifier Source: org_study_id