NCT05984095

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 9, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

September 15, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2023

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2023

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

August 1, 2023

Last Update Submit

November 26, 2023

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisPelvic FloorTelerehabilitationExercise

Outcome Measures

Primary Outcomes (5)

  • 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

    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)

    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)

    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)

    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)

    At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)

Study Arms (2)

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.

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.

Other: Telerehabilitation

Interventions

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.

REMOTESELF

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CdL in Fisioterapia

Trieste, 34100, Italy

Location

Related Publications (1)

  • 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.

    PMID: 39223424DERIVED

MeSH Terms

Conditions

Multiple SclerosisMotor Activity

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Paolo Manganotti, MD PhD

    University of Trieste

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The investigator in charge of reviewing the questionnaires and calculating the scores was not informed about the group of the participant.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research fellow

Study Record Dates

First Submitted

August 1, 2023

First Posted

August 9, 2023

Study Start

September 15, 2023

Primary Completion

November 15, 2023

Study Completion

November 25, 2023

Last Updated

November 28, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)