Efficacy of the Multidisciplinary Treatment to the Quality of Life of With Functional Movement Disorders
NCT ID: NCT05634486
Last Updated: 2024-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2022-06-15
2023-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Multidisciplinary therapeutic approach
* Diagnosis of Functional Movement Disorders by one of the PI (Movement Disorders Specialist).
* 12 physiotherapy sessions during one month (three 60-minute sessions per week) administered by a physiotherapist with experience in functional neurological disorders.
* 4 cognitive-behavioral therapy sessions during one month (one 60-minute intervention per week) administered by a psychologist with experience in cognitive-behavioral therapy.
Multidisciplinary therapeutic approach (physiotherapy plus cognitive-behavioral therapy)
Patients randomly allocated to this arm of intervention will receive an ambulatory therapy regime of twelve 60-minute physiotherapy sessions plus four 60-minute psychotherapy sessions throughout one month of treatment
Psychoeducation
* Diagnosis of Functional Movement Disorders by one of the PI (Movement Disorders Specialist).
* 4 psychoeducational sessions (one 60-minute intervention per week) administered by a psychologist with experience in cognitive-behavioral therapy.
Psychoeducation (Sham intervention)
Patients randomly allocated to this arm of intervention will receive an ambulatory regime of four 60-minute non-organized psychoeducational sessions throughout one month of treatment.
Interventions
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Multidisciplinary therapeutic approach (physiotherapy plus cognitive-behavioral therapy)
Patients randomly allocated to this arm of intervention will receive an ambulatory therapy regime of twelve 60-minute physiotherapy sessions plus four 60-minute psychotherapy sessions throughout one month of treatment
Psychoeducation (Sham intervention)
Patients randomly allocated to this arm of intervention will receive an ambulatory regime of four 60-minute non-organized psychoeducational sessions throughout one month of treatment.
Eligibility Criteria
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Inclusion Criteria
* Patients should be 18 years old or older and capable of giving consent to freely and willingly participate in the study.
* Patients should be able to attend the one-month ambulatory regime and follow-up visits.
Exclusion Criteria
* Any non-controlled psychiatric disorders
18 Years
ALL
No
Sponsors
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Fundación Caser
UNKNOWN
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
OTHER
Responsible Party
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Principal Investigators
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Pablo Mir, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Virgen del Rocío / Instituto de Biomedicina de Sevilla (IBiS)
Locations
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Hospital Universitario Virgen del Rocío / Instituto de Biomedicina de Sevilla (IBiS)
Seville, , Spain
Countries
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References
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Macias-Garcia D, Mendez-Del Barrio M, Canal-Rivero M, Munoz-Delgado L, Adarmes-Gomez A, Jesus S, Ojeda-Lepe E, Carrillo-Garcia F, Palomar FJ, Gomez-Campos FJ, Martin-Rodriguez JF, Crespo-Facorro B, Ruiz-Veguilla M, Mir P. Combined Physiotherapy and Cognitive Behavioral Therapy for Functional Movement Disorders: A Randomized Clinical Trial. JAMA Neurol. 2024 Sep 1;81(9):966-976. doi: 10.1001/jamaneurol.2024.2393.
Related Links
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Sponsor official statement of financial support
Other Identifiers
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1633-N-21
Identifier Type: -
Identifier Source: org_study_id
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