Multiple SclerosisNCT05984095
Multiple Sclerosis Pelvic Floor Telerehabilitation
A study testing Telerehabilitation in people with Multiple Sclerosis, run by University of Trieste at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Telerehabilitation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteItaly
- Study dates
- 15 Sep 2023to 25 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read more
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Telerehabilitation
- Keywords
- Multiple Sclerosis, Pelvic Floor, Telerehabilitation, Exercise
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| SELF | Active comparator | 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. Receives: Other: Telerehabilitation |
| REMOTE | Experimental | 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. Receives: Other: Telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start15 Sep 2023
- Primary completion15 Nov 2023
- Study completion25 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Trieste
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alex Buoite Stella, University of Trieste
- Investigators
- Paolo Manganotti, MD PhD, Study chair, University of Trieste
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05984095
- Sponsor's protocol ID
- Fisioterapia1907
- Status last verified
- Nov 2023
- First submitted
- 1 Aug 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39223424
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Floor Rehabilitation in Females With Multiple Sclerosis: Comparison of Two Telerehabilitation Protocols
- ClinicalTrials.gov ID
- NCT05984095
- Acronym / sponsor ID
- Fisioterapia1907
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Pelvic Floor, Telerehabilitation, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of TriesteUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 25 Nov 2023 (actual)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SELF | Active comparator | Other: TelerehabilitationAll 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. |
| REMOTE | Experimental | Other: TelerehabilitationAll 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelerehabilitationThe intervention was administered in a telerehabilitation fashion through a videocall on the phone or tablet, by a physiotherapist, in a one-to-one session. | Other | REMOTE, SELF |
Primary outcome
Pain perception
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Derived from this study: PubMed 39223424Deodato 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Manganotti, MD PhD study chair
University of Trieste
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation in people with Multiple Sclerosis, run by University of Trieste at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain perception (time frame: At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05984095, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023; AzTrials last refreshed its copy on 3 Nov 2026.