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

Primary Purpose

Functional Neurological Disorder, Functional Movement Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Multidisciplinary therapeutic approach (physiotherapy plus cognitive-behavioral therapy)
Psychoeducation (Sham intervention)
Sponsored by
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Neurological Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitario Virgen del Rocío / Instituto de Biomedicina de Sevilla (IBiS)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Multidisciplinary therapeutic approach

Psychoeducation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Quality of Life in patients with functional movement disorders measured by The 5-level EQ-5D version (EQ-5D-5L) - EQ visual analogue scale
Change in the patients' quality of life measured by changes in EQ-5D-5L - the EQ visual analogue scale (EQ VAS).
Quality of Life in patients with functional movement disorders measured by The 5-level EQ-5D version (EQ-5D-5L) - EQ-5D descriptive system.
Change in the patients' quality of life measured by changes in EQ-5D-5L - EQ-5D descriptive system. The digits for the five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) can be combined into a 5-digit number that describes the patient's health state.
Quality of Life in patients with functional movement disorders measured by the 36-Item Short Form Health Survey (SF-36)
Change in the patients' quality of life measured by changes in SF-36

Secondary Outcome Measures

Quality of Life in caregivers of patients with functional movement disorders
Change in the caregivers' quality of life measured by changes in the Zarit Caregiver Burden Interview
Severity of functional neurological symptoms of patients with functional movement disorders measured by Clinical Global Impressions (CGI) Scale
Change in the patients' symptoms severity measured by changes in the Clinical Global Impressions (CGI) Scale - Severity
Improvement of functional neurological symptoms of patients with functional movement disorders
Improvement of the patients' symptoms severity measured by the Clinical Global Impressions (CGI) Scale - Improvement
Severity of functional neurological symptoms of patients with functional movement disorders
Change in the patients' symptoms severity measured by changes in the simplified-Functional Movement Disorders Rating Scale

Full Information

First Posted
November 21, 2022
Last Updated
November 30, 2022
Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Collaborators
Fundación Caser
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1. Study Identification

Unique Protocol Identification Number
NCT05634486
Brief Title
Efficacy of the Multidisciplinary Treatment to the Quality of Life of With Functional Movement Disorders
Official Title
Efficacy Study of the Multidisciplinary Therapeutic Approach to the Quality of Life of Patients With Functional Movement Disorders and Their Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Collaborators
Fundación Caser

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Neurological Disorder, Functional Movement Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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).
Masking
Investigator
Masking Description
Movement disorders specialists will review the severity of symptoms as blinded raters in the 3th-month and 5th-month follow-up.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multidisciplinary therapeutic approach
Arm Type
Experimental
Arm Description
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.
Arm Title
Psychoeducation
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Multidisciplinary therapeutic approach (physiotherapy plus cognitive-behavioral therapy)
Intervention Description
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
Other
Intervention Name(s)
Psychoeducation (Sham intervention)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of Life in patients with functional movement disorders measured by The 5-level EQ-5D version (EQ-5D-5L) - EQ visual analogue scale
Description
Change in the patients' quality of life measured by changes in EQ-5D-5L - the EQ visual analogue scale (EQ VAS).
Time Frame
3th-month and 5th-month follow-ups
Title
Quality of Life in patients with functional movement disorders measured by The 5-level EQ-5D version (EQ-5D-5L) - EQ-5D descriptive system.
Description
Change in the patients' quality of life measured by changes in EQ-5D-5L - EQ-5D descriptive system. The digits for the five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) can be combined into a 5-digit number that describes the patient's health state.
Time Frame
3th-month and 5th-month follow-ups
Title
Quality of Life in patients with functional movement disorders measured by the 36-Item Short Form Health Survey (SF-36)
Description
Change in the patients' quality of life measured by changes in SF-36
Time Frame
3th-month and 5th-month follow-ups
Secondary Outcome Measure Information:
Title
Quality of Life in caregivers of patients with functional movement disorders
Description
Change in the caregivers' quality of life measured by changes in the Zarit Caregiver Burden Interview
Time Frame
3th-month and 5th-month follow-ups
Title
Severity of functional neurological symptoms of patients with functional movement disorders measured by Clinical Global Impressions (CGI) Scale
Description
Change in the patients' symptoms severity measured by changes in the Clinical Global Impressions (CGI) Scale - Severity
Time Frame
3th-month and 5th-month follow-ups
Title
Improvement of functional neurological symptoms of patients with functional movement disorders
Description
Improvement of the patients' symptoms severity measured by the Clinical Global Impressions (CGI) Scale - Improvement
Time Frame
3th-month and 5th-month follow-ups
Title
Severity of functional neurological symptoms of patients with functional movement disorders
Description
Change in the patients' symptoms severity measured by changes in the simplified-Functional Movement Disorders Rating Scale
Time Frame
3th-month and 5th-month follow-ups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Macías García, MD, PhD
Phone
955923039
Email
dmacias-ibis@us.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pablo Mir, MD, PhD
Organizational Affiliation
Hospital Universitario Virgen del Rocío / Instituto de Biomedicina de Sevilla (IBiS)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Virgen del Rocío / Instituto de Biomedicina de Sevilla (IBiS)
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Gómez Rapela, Study Coordinator
Phone
955
Email
cgomez-ibis@us.es
First Name & Middle Initial & Last Name & Degree
Pablo Mir, MD, PhD
First Name & Middle Initial & Last Name & Degree
Daniel Macías García, MD, PhD

12. IPD Sharing Statement

Links:
URL
https://www.fundacioncaser.org/actividades/ayudas-investigacion-sociosanitaria/ayudas-la-investigacion-sociosanitaria-2021
Description
Sponsor official statement of financial support

Learn more about this trial

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

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