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Efficacy of the Multidisciplinary Treatment to the Quality of Life of With Functional Movement Disorders

NCT05634486 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-02-22

No results posted yet for this study

Summary

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.

Conditions

  • Functional Neurological Disorder
  • Functional Movement Disorder

Interventions

BEHAVIORAL

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

OTHER

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.

Sponsors & Collaborators

  • Fundación Caser

    collaborator UNKNOWN

  • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

    lead OTHER

Principal Investigators

  • Pablo Mir, MD, PhD · Hospital Universitario Virgen del Rocío / Instituto de Biomedicina de Sevilla (IBiS)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-15
Primary Completion
2023-08-31
Completion
2023-10-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05634486 on ClinicalTrials.gov