Effect of an Internet-Based Pilates Telerehabilitation Intervention in People With Multiple Sclerosis: Protocol for a Randomized Controlled Trial

BackgroundPhysical activity (PA) has been recommended in multiple sclerosis (MS) to maintain good physical fitness and mental health, reduce the severity of symptoms and risk of relapse, and improve quality of life. Pilates has been suggested as an ideal PA to manage physical...

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Main Authors: Andrea Tacchino, Michela Ponzio, Paolo Confalonieri, Letizia Leocani, Matilde Inglese, Diego Centonze, Eleonora Cocco, Paolo Gallo, Damiano Paolicelli, Marco Rovaris, Loredana Sabattini, Gioacchino Tedeschi, Luca Prosperini, Francesco Patti, Edoardo Sessa, Elisabetta Pedrazzoli, Mario Alberto Battaglia, Giampaolo Brichetto
Format: Article
Language:English
Published: JMIR Publications 2025-02-01
Series:JMIR Research Protocols
Online Access:https://www.researchprotocols.org/2025/1/e58026
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author Andrea Tacchino
Michela Ponzio
Paolo Confalonieri
Letizia Leocani
Matilde Inglese
Diego Centonze
Eleonora Cocco
Paolo Gallo
Damiano Paolicelli
Marco Rovaris
Loredana Sabattini
Gioacchino Tedeschi
Luca Prosperini
Francesco Patti
Edoardo Sessa
Elisabetta Pedrazzoli
Mario Alberto Battaglia
Giampaolo Brichetto
author_facet Andrea Tacchino
Michela Ponzio
Paolo Confalonieri
Letizia Leocani
Matilde Inglese
Diego Centonze
Eleonora Cocco
Paolo Gallo
Damiano Paolicelli
Marco Rovaris
Loredana Sabattini
Gioacchino Tedeschi
Luca Prosperini
Francesco Patti
Edoardo Sessa
Elisabetta Pedrazzoli
Mario Alberto Battaglia
Giampaolo Brichetto
author_sort Andrea Tacchino
collection DOAJ
description BackgroundPhysical activity (PA) has been recommended in multiple sclerosis (MS) to maintain good physical fitness and mental health, reduce the severity of symptoms and risk of relapse, and improve quality of life. Pilates has been suggested as an ideal PA to manage physical, cognitive, and psychological symptoms of MS and a useful method to maintain and improve balance and gait. ObjectiveThis paper presents the protocol for a study that aims to evaluate the efficacy on the physical domain (specifically balance and gait) of a home-based, self-managed PA intervention delivered through the MS-FIT exergame (HELAGLOBE Società a responsabilità limitata). In addition, measures of cognitive performance, quality of life, and well-being will be considered. MethodsThis is a 2-arm, multicenter, randomized controlled trial with 3 assessment points (baseline, 12 weeks postintervention, and 6 weeks follow-up). People with MS with mild disability, low risk of falling, preserved cognitive functions, and low anxiety and depression are potential eligible participants. The experimental group (MS-FIT) will self-administer the MS-FIT exergame at home in addition to their leisure-time physical activities. MS-FIT is an internet- and Pilates-based tool that uses the Microsoft Kinect Sensor V2. Participants in the control group will only have access to their leisure-time physical activities. Participants in the MS-FIT group will train at home with MS-FIT for 12 weeks and will be required to perform the exercises for a total of 30 minutes/day for at least 3 days/week. The primary outcome is the Timed Up and Go, a test designed to assess walking. We will also administer additional tests for motor function (visual analog scale 0-10, Timed 25-Foot Walk, Ambulation Index, 2-minute walk test, Twelve Item Multiple Sclerosis Walking Scale, Nine-Hole Peg Test), cognition (Brief International Cognitive Assessment for Multiple Sclerosis), fatigue (Modified Fatigue Impact Scale), quality of life (Multiple Sclerosis Quality of Life-54), well-being (Psychological Well-Being Scales), and PA (International Physical Activity Questionnaire and Minnesota Leisure Time Physical Activity Questionnaire). Acceptance and satisfaction with the intervention received (Client Satisfaction Questionnaire and an adapted version of the Tele-healthcare Satisfaction Questionnaire – Wearable Technology) and subjective impressions of changes in performance (Patients’ Global Impression of Change) will also be assessed. ResultsRecruitment for the trial started on March 16, 2022, and the first participant was randomized the same day. Data analysis and results are expected to be published in 2025. ConclusionsPilates has proven beneficial in several neurological diseases such as MS. With this study, we will provide evidence for the use in clinical practice of a digital tool for self-administered Pilates exercises at home as a complement to rehabilitation and for the continuity of care in MS. Trial RegistrationClinicalTrials.gov NCT04011579; https://tinyurl.com/2p9n4d2t International Registered Report Identifier (IRRID)DERR1-10.2196/58026
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spelling doaj-art-e15dc998edbc40399ef8f4c53cbc4cdd2025-02-03T21:30:51ZengJMIR PublicationsJMIR Research Protocols1929-07482025-02-0114e5802610.2196/58026Effect of an Internet-Based Pilates Telerehabilitation Intervention in People With Multiple Sclerosis: Protocol for a Randomized Controlled TrialAndrea Tacchinohttps://orcid.org/0000-0002-2263-7315Michela Ponziohttps://orcid.org/0000-0001-5245-0474Paolo Confalonierihttps://orcid.org/0000-0001-8030-5725Letizia Leocanihttps://orcid.org/0000-0001-9326-6753Matilde Inglesehttps://orcid.org/0000-0002-9610-0297Diego Centonzehttps://orcid.org/0000-0002-8390-8545Eleonora Coccohttps://orcid.org/0000-0002-3878-8820Paolo Gallohttps://orcid.org/0000-0003-3886-4181Damiano Paolicellihttps://orcid.org/0000-0002-8645-1763Marco Rovarishttps://orcid.org/0000-0001-9691-1957Loredana Sabattinihttps://orcid.org/0000-0002-6196-6672Gioacchino Tedeschihttps://orcid.org/0000-0002-3321-1125Luca Prosperinihttps://orcid.org/0000-0003-3237-6267Francesco Pattihttps://orcid.org/0000-0002-6923-0846Edoardo Sessahttps://orcid.org/0000-0001-7352-4911Elisabetta Pedrazzolihttps://orcid.org/0000-0002-1337-068XMario Alberto Battagliahttps://orcid.org/0000-0002-8106-8239Giampaolo Brichettohttps://orcid.org/0000-0003-2026-3572 BackgroundPhysical activity (PA) has been recommended in multiple sclerosis (MS) to maintain good physical fitness and mental health, reduce the severity of symptoms and risk of relapse, and improve quality of life. Pilates has been suggested as an ideal PA to manage physical, cognitive, and psychological symptoms of MS and a useful method to maintain and improve balance and gait. ObjectiveThis paper presents the protocol for a study that aims to evaluate the efficacy on the physical domain (specifically balance and gait) of a home-based, self-managed PA intervention delivered through the MS-FIT exergame (HELAGLOBE Società a responsabilità limitata). In addition, measures of cognitive performance, quality of life, and well-being will be considered. MethodsThis is a 2-arm, multicenter, randomized controlled trial with 3 assessment points (baseline, 12 weeks postintervention, and 6 weeks follow-up). People with MS with mild disability, low risk of falling, preserved cognitive functions, and low anxiety and depression are potential eligible participants. The experimental group (MS-FIT) will self-administer the MS-FIT exergame at home in addition to their leisure-time physical activities. MS-FIT is an internet- and Pilates-based tool that uses the Microsoft Kinect Sensor V2. Participants in the control group will only have access to their leisure-time physical activities. Participants in the MS-FIT group will train at home with MS-FIT for 12 weeks and will be required to perform the exercises for a total of 30 minutes/day for at least 3 days/week. The primary outcome is the Timed Up and Go, a test designed to assess walking. We will also administer additional tests for motor function (visual analog scale 0-10, Timed 25-Foot Walk, Ambulation Index, 2-minute walk test, Twelve Item Multiple Sclerosis Walking Scale, Nine-Hole Peg Test), cognition (Brief International Cognitive Assessment for Multiple Sclerosis), fatigue (Modified Fatigue Impact Scale), quality of life (Multiple Sclerosis Quality of Life-54), well-being (Psychological Well-Being Scales), and PA (International Physical Activity Questionnaire and Minnesota Leisure Time Physical Activity Questionnaire). Acceptance and satisfaction with the intervention received (Client Satisfaction Questionnaire and an adapted version of the Tele-healthcare Satisfaction Questionnaire – Wearable Technology) and subjective impressions of changes in performance (Patients’ Global Impression of Change) will also be assessed. ResultsRecruitment for the trial started on March 16, 2022, and the first participant was randomized the same day. Data analysis and results are expected to be published in 2025. ConclusionsPilates has proven beneficial in several neurological diseases such as MS. With this study, we will provide evidence for the use in clinical practice of a digital tool for self-administered Pilates exercises at home as a complement to rehabilitation and for the continuity of care in MS. Trial RegistrationClinicalTrials.gov NCT04011579; https://tinyurl.com/2p9n4d2t International Registered Report Identifier (IRRID)DERR1-10.2196/58026https://www.researchprotocols.org/2025/1/e58026
spellingShingle Andrea Tacchino
Michela Ponzio
Paolo Confalonieri
Letizia Leocani
Matilde Inglese
Diego Centonze
Eleonora Cocco
Paolo Gallo
Damiano Paolicelli
Marco Rovaris
Loredana Sabattini
Gioacchino Tedeschi
Luca Prosperini
Francesco Patti
Edoardo Sessa
Elisabetta Pedrazzoli
Mario Alberto Battaglia
Giampaolo Brichetto
Effect of an Internet-Based Pilates Telerehabilitation Intervention in People With Multiple Sclerosis: Protocol for a Randomized Controlled Trial
JMIR Research Protocols
title Effect of an Internet-Based Pilates Telerehabilitation Intervention in People With Multiple Sclerosis: Protocol for a Randomized Controlled Trial
title_full Effect of an Internet-Based Pilates Telerehabilitation Intervention in People With Multiple Sclerosis: Protocol for a Randomized Controlled Trial
title_fullStr Effect of an Internet-Based Pilates Telerehabilitation Intervention in People With Multiple Sclerosis: Protocol for a Randomized Controlled Trial
title_full_unstemmed Effect of an Internet-Based Pilates Telerehabilitation Intervention in People With Multiple Sclerosis: Protocol for a Randomized Controlled Trial
title_short Effect of an Internet-Based Pilates Telerehabilitation Intervention in People With Multiple Sclerosis: Protocol for a Randomized Controlled Trial
title_sort effect of an internet based pilates telerehabilitation intervention in people with multiple sclerosis protocol for a randomized controlled trial
url https://www.researchprotocols.org/2025/1/e58026
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