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Protocol in Musician's Focal Dystonia (MISA) (MISA)

3 novembre 2026 aggiornato da: Fondazione Don Carlo Gnocchi ETS

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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).

Tipo di studio

Osservativo

Iscrizione (Effettivo)

70

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Florence, Italia
        • IRCCS Fondazione Don Carlo Gnocchi - Centro IRCCS Don Carlo Gnocchi Firenze
    • Italy
      • Milan, Italy, Italia, 20148
        • IRCCS Fondazione Don Carlo Gnocchi - Santa Maria Nascente

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: CASE_ONLY
  • Prospettive temporali: RETROSPECTIVE

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Technical Ability (TA) score of the Technical Ability and Performing Scale (TAPS)
Lasso di tempo: From baseline (T0) through end of treatment (T1), up to 24 weeks.

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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Performimg Scale (PS) score of the Technical Ability and Performing Scale (TAPS)
Lasso di tempo: From baseline (T0) through end of treatment (T1), up to 24 weeks.

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.
Predictors of change in Technical Ability (TA) score
Lasso di tempo: From baseline (T0) through end of treatment (T1), up to 24 weeks.

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.
Predictors of change in Performing Scale (PS) score
Lasso di tempo: From baseline (T0) through end of treatment (T1), up to 24 weeks.

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.
Predictors of treatment dropout
Lasso di tempo: From baseline (T0) through end of treatment (T1), up to 24 weeks.

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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Collaboratori

Investigatori

  • Investigatore principale: Marina Ramella, MD, IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 luglio 2017

Completamento primario (Effettivo)

1 maggio 2026

Completamento dello studio (Effettivo)

1 maggio 2026

Date di iscrizione allo studio

Primo inviato

31 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 novembre 2026

Primo Inserito (Effettivo)

6 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 novembre 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • MISA

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .