- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Florence, Italy
- IRCCS Fondazione Don Carlo Gnocchi - Centro IRCCS Don Carlo Gnocchi Firenze
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Italy
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Milan, Italy, Italy, 20148
- IRCCS Fondazione Don Carlo Gnocchi - Santa Maria Nascente
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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.
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: CASE_ONLY
- Time Perspectives: RETROSPECTIVE
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Technical Ability (TA) score of the Technical Ability and Performing Scale (TAPS)
Time Frame: 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.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Performimg Scale (PS) score of the Technical Ability and Performing Scale (TAPS)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Marina Ramella, MD, IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Motor Control
- Focal Hand Dystonia
- Motor Learning
- Neurorehabilitation
- Musicians
- Sensorimotor Integration
- Mirror Therapy
- TAPS
- Motor Rehabilitation
- Hand Dystonia
- Music Performance
- Musician's Focal Dystonia
- Task-Specific Dystonia
- Sensorimotor Retraining
- Graded Motor Training
- Technical Ability and Performing Scale
- Modified Integrated Sensorimotor Approach
- MISA
Additional Relevant MeSH Terms
Other Study ID Numbers
- MISA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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