Multiple Sclerosis Pelvic Floor Telerehabilitation
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Pain perception [At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)]
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 [At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)]
Evaluation of depression symptoms with the Beck Depression Inventory Scale (BDI, 0-63, higher the score worse the depression)
- Perceived quality of life [At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)]
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 [At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)]
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 [At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)]
Evaluation of urinary incontinence symptoms with the International Consultation on Incontinence Questionnaire (ICIQ, 0-21, higher the score worse the symptoms)
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CdL in Fisioterapia | Trieste | Italy | 34100 |
Sponsors and Collaborators
- University of Trieste
Investigators
- Study Chair: Paolo Manganotti, MD PhD, University of Trieste
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Fisioterapia1907