Clinical trial NCT05634486: 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
Overall status: COMPLETED
Phase: NA
Conditions: Functional Neurological Disorder
Functional Movement Disorder
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
Collaborators: name: Fundación Caser
First posted: 2022-12-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Quality of Life in patients with functional movement disorders measured by The 5-level EQ-5D version (EQ-5D-5L) - EQ visual analogue scale
timeFrame: 3th-month and 5th-month follow-ups
measure: Quality of Life in patients with functional movement disorders measured by The 5-level EQ-5D version (EQ-5D-5L) - EQ-5D descriptive system.
timeFrame: 3th-month and 5th-month follow-ups
measure: Quality of Life in patients with functional movement disorders measured by the 36-Item Short Form Health Survey (SF-36)
timeFrame: 3th-month and 5th-month follow-ups
Secondary outcomes:
measure: Quality of Life in caregivers of patients with functional movement disorders
timeFrame: 3th-month and 5th-month follow-ups
measure: Severity of functional neurological symptoms of patients with functional movement disorders measured by Clinical Global Impressions (CGI) Scale
timeFrame: 3th-month and 5th-month follow-ups
measure: Improvement of functional neurological symptoms of patients with functional movement disorders
timeFrame: 3th-month and 5th-month follow-ups
measure: Severity of functional neurological symptoms of patients with functional movement disorders
timeFrame: 3th-month and 5th-month follow-ups
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío / Instituto de Biomedicina de Sevilla (IBiS)
Study officials:
affiliation: Hospital Universitario Virgen del Rocío / Instituto de Biomedicina de Sevilla (IBiS)
name: Pablo Mir, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: