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

NCT05634486 | Completed

• 1 other identifier: 1633-N-21
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Neurological Disorder; Functional Movement Disorder

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (4)

• Quality of Life in caregivers of patients with functional movement disorders

  3th-month and 5th-month follow-ups

• Severity of functional neurological symptoms of patients with functional movement disorders measured by Clinical Global Impressions (CGI) Scale

  3th-month and 5th-month follow-ups

• Improvement of functional neurological symptoms of patients with functional movement disorders

  3th-month and 5th-month follow-ups

• Severity of functional neurological symptoms of patients with functional movement disorders

  3th-month and 5th-month follow-ups

Study Arms (2)

Multidisciplinary therapeutic approach

EXPERIMENTAL

* 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.

Behavioral: Multidisciplinary therapeutic approach (physiotherapy plus cognitive-behavioral therapy)

Psychoeducation

SHAM COMPARATOR

* 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.

Other: Psychoeducation (Sham intervention)

Interventions

Multidisciplinary therapeutic approach (physiotherapy plus cognitive-behavioral therapy) 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

Multidisciplinary therapeutic approach

Psychoeducation (Sham intervention) 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.

Psychoeducation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Any condition that avoid the patient from giving free consent to participate in the study.
• Any non-controlled psychiatric disorders

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead
• Fundación Caser: collaborator

Study Sites (1)

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

Seville, 41013, Spain

Location

Related Publications (1)

• 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.

  PMID: 39102249 DERIVED

Related Links

• Sponsor official statement of financial support

MeSH Terms

Conditions

Conversion Disorder

Interventions

Physical Therapy Modalities; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Pablo Mir, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Movement disorders specialists will review the severity of symptoms as blinded raters in the 3th-month and 5th-month follow-up.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 2, 2022
• Study Start: June 15, 2022
• Primary Completion: August 31, 2023
• Study Completion: October 31, 2023
• Last Updated: February 22, 2024

Record last verified: 2024-02

Locations

ES (1)