- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07923799
Protocol in Musician's Focal Dystonia (MISA) (MISA)
Effectiveness of the MISA (Mirror Integrated Sensorimotor Approach) Rehabilitation Protocol for Musicians With Focal Dystonia: A Retrospective Observational Study
Musician's Focal Dystonia (MFD) is a task-specific movement disorder that impairs fine motor control during musical performance and may severely affect professional and amateur musicians. The Modified Integrated Sensorimotor Approach (MISA) is a standardized home-based rehabilitation program that combines mirror therapy, sensory reorganization exercises, graded motor training, and motor awareness strategies to promote sensorimotor retraining.
This retrospective observational study aims to evaluate the association between participation in the MISA rehabilitation program and changes in musical performance among musicians with focal hand dystonia. Musical performance is assessed using the Technical Ability and Performing Scale (TAPS), a patient-reported outcome measure specifically developed for musicians with focal dystonia. Secondary objectives include the investigation of clinical and individual factors potentially associated with treatment response.
The study consists of a review of clinical records of patients who completed the MISA program as part of routine clinical care at the Sol Diesis Outpatient Clinic, IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Musician's Focal Dystonia (MFD) is a task-specific movement disorder characterized by loss of fine motor control, involuntary muscle contractions, and abnormal movement patterns that emerge during musical performance. The condition is thought to result from maladaptive neuroplasticity, impaired sensorimotor integration, and abnormalities in cortical inhibitory mechanisms. These alterations interfere with highly trained motor skills and may profoundly affect professional and amateur musicians.
Although pharmacological treatments, including botulinum toxin injections and oral medications, may provide symptomatic benefit, rehabilitation interventions have become an increasingly important component of MFD management. Previous studies have suggested that sensorimotor retraining approaches, including mirror therapy, sensory reorganization, graded motor training, and motor control exercises, may improve musical performance and reduce dystonic symptoms.
The Modified Integrated Sensorimotor Approach (MISA) is a structured home-based rehabilitation protocol developed at the Sol Diesis Outpatient Clinic of IRCCS Fondazione Don Carlo Gnocchi. The protocol integrates mirror therapy, sensory reorganization exercises, graded motor training, and motor awareness strategies within a progressive framework of increasing task complexity. The intervention aims to promote adaptive sensorimotor reorganization, improve movement selectivity, reduce maladaptive co-contraction patterns, and facilitate transfer of acquired motor skills to musical performance.
This retrospective observational study involves the review of medical records of adult musicians with instrument-specific focal dystonia who underwent the MISA rehabilitation program as part of routine clinical care between July 2017 and May 2026. Data collected include demographic and professional characteristics, clinical features of dystonia, treatment characteristics, and musical performance outcomes.
Musical performance was assessed using the Technical Ability and Performing Scale (TAPS), a patient-reported outcome measure specifically developed for musicians with focal dystonia. Assessments performed before treatment initiation (T0) and at completion of the rehabilitation program (T1) were used to evaluate treatment-related changes.
The primary objective of the study is to explore the association between participation in the MISA rehabilitation program and changes in musical performance measured by TAPS scores. Secondary objectives include the investigation of associations between treatment-related changes and individual or clinical characteristics of participants, including age, sex, instrument played, disease duration, dystonia pattern, and affected body segments.
The study is conducted in accordance with the Declaration of Helsinki and was approved by the Ethics Committee CET Lombardia 4 (Approval No. CET 90-26).
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Florence, Italien
- IRCCS Fondazione Don Carlo Gnocchi - Centro IRCCS Don Carlo Gnocchi Firenze
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Italy
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Milan, Italy, Italien, 20148
- IRCCS Fondazione Don Carlo Gnocchi - Santa Maria Nascente
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Adult professional and amateur musicians with instrument-specific focal hand dystonia who initiated the Modified Integrated Sensorimotor Approach (MISA) rehabilitation program at the Sol Diesis Outpatient Clinic, IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy. Participants were identified through retrospective review of medical records collected between July 2017 and May 2026. Both program completers and participants who discontinued treatment were included in the study.
Beschreibung
Inclusion Criteria:
- Age ≥18 years.
- Professional or amateur musician.
- Clinical diagnosis of instrument-specific focal dystonia.
- Participation in the Modified Integrated Sensorimotor Approach (MISA) rehabilitation program.
- Availability of baseline Technical Ability and Performing Scale (TAPS) assessment.
- Availability of post-treatment TAPS assessment, when available.
- Availability of informed consent or absence of documented opposition to the processing of personal data for research purposes.
Exclusion Criteria:
- Neurological disorders or clinical conditions potentially mimicking or confounding the diagnosis of focal dystonia.
- Forms of dystonia other than instrument-specific focal dystonia.
- Insufficient baseline clinical documentation.
- Botulinum toxin treatment within 3 months prior to initiation of the MISA program.
- Botulinum toxin treatment administered during the MISA rehabilitation program.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: CASE_ONLY
- Zeitperspektiven: RETROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
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Musicians With Focal Hand Dystonia Treated With MISA
Adult professional and amateur musicians with instrument-specific focal hand dystonia who completed the Modified Integrated Sensorimotor Approach (MISA) rehabilitation program as part of routine clinical care. Participants were evaluated at baseline and after completion of the rehabilitation program using the Technical Ability and Performing Scale (TAPS). |
The Modified Integrated Sensorimotor Approach (MISA) is a standardized home-based rehabilitation program for musicians with focal hand dystonia. The intervention combines mirror therapy, sensory reorganization exercises, graded motor training, motor awareness strategies, and progressive task-oriented practice. The program consists of six modules delivered across approximately 12 weeks, with individualized instruction provided by a physiotherapist and independent home exercises performed four days per week. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in Technical Ability (TA) score of the Technical Ability and Performing Scale (TAPS)
Zeitfenster: From baseline (T0) through end of treatment (T1), up to 24 weeks.
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Change from baseline (T0) to post-treatment assessment (T1) in musical performance measured using the Technical Ability (TA) score of the Technical Ability and Performing Scale (TAPS). The TA score ranges from 0 to 10 points, with 0 indicating the poorest technical performance and 10 indicating the best technical performance. Higher scores indicate better technical performance. |
From baseline (T0) through end of treatment (T1), up to 24 weeks.
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Change in Performimg Scale (PS) score of the Technical Ability and Performing Scale (TAPS)
Zeitfenster: From baseline (T0) through end of treatment (T1), up to 24 weeks.
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Change from baseline (T0) to post-treatment assessment (T1) in musical performance measured using the Performance Scale (PS) score of the Technical Ability and Performing Scale (TAPS). The PS score ranges from 0 to 10 points, with 0 indicating the poorest musical performance and 10 indicating the best musical performance. Higher scores indicate better musical performance. |
From baseline (T0) through end of treatment (T1), up to 24 weeks.
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Predictors of change in Technical Ability (TA) score
Zeitfenster: From baseline (T0) through end of treatment (T1), up to 24 weeks.
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Exploratory analyses will assess the association between change in TA score (points) and participant characteristics, including age (years), sex, musical instrument, professional status, age at dystonia onset (years), disease duration (years), affected body side, affected body segments, number of affected segments, and dystonia pattern. |
From baseline (T0) through end of treatment (T1), up to 24 weeks.
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Predictors of change in Performing Scale (PS) score
Zeitfenster: From baseline (T0) through end of treatment (T1), up to 24 weeks.
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Exploratory analyses will assess the association between change in PS score (points) and participant characteristics, including age (years), sex, musical instrument, professional status, age at dystonia onset (years), disease duration (years), affected body side, affected body segments, number of affected segments, and dystonia pattern. |
From baseline (T0) through end of treatment (T1), up to 24 weeks.
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Predictors of treatment dropout
Zeitfenster: From baseline (T0) through end of treatment (T1), up to 24 weeks.
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Exploratory analysis of baseline predictors of treatment dropout. The outcome will be dropout status (dropout vs. treatment completion). Potential predictors assessed at baseline (T0) will include Technical Ability (TA) score of the Technical Ability and Performing Scale (TAPS) (points), Performance Scale (PS) score of the Technical Ability and Performing Scale (TAPS) (points), age (years), sex, musical instrument, professional status, age at dystonia onset (years), disease duration (years), affected body side, affected body segments, number of affected segments, and dystonia pattern. |
From baseline (T0) through end of treatment (T1), up to 24 weeks.
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Marina Ramella, MD, IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Prudente CN, Zetterberg L, Bring A, Bradnam L, Kimberley TJ. Systematic Review of Rehabilitation in Focal Dystonias: Classification and Recommendations. Mov Disord Clin Pract. 2018 Mar 13;5(3):237-245. doi: 10.1002/mdc3.12574. eCollection 2018 May-Jun.
- Ramella M, Converti RM, Giacobbi G, Castagna A, Saibene E, Borgnis F, Baglio F. The Technical Ability and Performing Scale (TAPS): A newly developed patient-reported functional rating scale for Musician's focal dystonia. Parkinsonism Relat Disord. 2022 Jun;99:79-83. doi: 10.1016/j.parkreldis.2022.05.015. Epub 2022 May 20.
- Ramella M, Borgnis F, Giacobbi G, Castagna A, Baglio F, Cortesi M, Converti RM. Modified Graded Motor Imagery for Musicians' Focal Dystonia: A Case Series. Med Probl Perform Art. 2021 Mar;36(1):10-17. doi: 10.21091/mppa.2021.1002.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
- Motorsteuerung
- Fokale Handdystonie
- Motorisches Lernen
- Neurorehabilitation
- Musiker
- Sensomotorische Integration
- Spiegeltherapie
- HÄHNE
- Motorische Rehabilitation
- Dystonie der Hand
- Musikaufführung
- Musician's Focal Dystonia
- Task-Specific Dystonia
- Sensorimotor Retraining
- Graded Motor Training
- Technical Ability and Performing Scale
- Modified Integrated Sensorimotor Approach
- MISA
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- MISA
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
Individual participant data will not be made publicly available due to the retrospective nature of the study and the need to protect participant confidentiality and privacy.
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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