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

Functional Neurological Disorder Clinical Trial

Official title:

Efficacy Study of the Multidisciplinary Therapeutic Approach to the Quality of Life of Patients With Functional Movement Disorders and Their Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05634486
• Other study ID #: 1633-N-21
• Status: Completed
• Phase: N/A
• Start date: June 15, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: February 2024
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Conversion Disorder
• Functional Movement Disorder
• Functional Neurological Disorder
• Movement Disorders
• Nervous System Diseases

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen del Rocío / Instituto de Biomedicina de Sevilla (IBiS)	Sevilla

Sponsors (2)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla	Fundación Caser

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	3th-month and 5th-month follow-ups
Primary	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.	3th-month and 5th-month follow-ups
Primary	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	3th-month and 5th-month follow-ups
Secondary	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	3th-month and 5th-month follow-ups
Secondary	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	3th-month and 5th-month follow-ups
Secondary	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	3th-month and 5th-month follow-ups
Secondary	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	3th-month and 5th-month follow-ups

External Links

•   Sponsor official statement of financial support