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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-15

Study Completion Date

2023-10-31

Brief Summary

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Randomized-clinical trial of multidisciplinary approach versus psychoeducation in patients with functional movement disorders: impact to their quality of life and their caregivers' quality of life. Patients with functional movement disorders are randomized in two arms of a one-month treatment (physiotherapy + cognitive-behavioral therapy versus psychoeducational as sham intervention) with a 3-month and 5-month follow-up where the investigators will measure the change in the patients' and caregivers' quality of life. Movement disorders specialists will review the severity of symptoms as blinded raters in the 3th-month and 5th-month follow-up.

Detailed Description

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Conditions

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Functional Neurological Disorder Functional Movement Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

40 patients with functional movement disorders will be randomized into two arms of treatments: a one-month multidisciplinary treatment (physiotherapy + cognitive-behavioral therapy) versus a one-month psychoeducation sham intervention (control group).
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
Movement disorders specialists will review the severity of symptoms as blinded raters in the 3th-month and 5th-month follow-up.

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.

Group Type EXPERIMENTAL

Multidisciplinary therapeutic approach (physiotherapy plus cognitive-behavioral therapy)

Intervention Type BEHAVIORAL

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.

Group Type SHAM_COMPARATOR

Psychoeducation (Sham intervention)

Intervention Type OTHER

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

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Functional Movement Disorders (Espay and Lang, 2015)
* 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 condition that avoid the patient from giving free consent to participate in the study.
* Any non-controlled psychiatric disorders
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación Caser

UNKNOWN

Sponsor Role collaborator

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Spain

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.

Reference Type DERIVED
PMID: 39102249 (View on PubMed)

Related Links

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Other Identifiers

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1633-N-21

Identifier Type: -

Identifier Source: org_study_id

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