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| Name | Class |
|---|---|
| Fundación Caser | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multidisciplinary therapeutic approach | Experimental |
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| Psychoeducation | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Severity of functional neurological symptoms of patients with functional movement disorders measured by Clinical Global Impressions (CGI) Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pablo Mir, MD, PhD | Hospital Universitario Virgen del RocÃo / Instituto de Biomedicina de Sevilla (IBiS) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen del RocÃo / Instituto de Biomedicina de Sevilla (IBiS) | Seville | 41013 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39102249 | Derived | 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. |
| Label | URL |
|---|---|
| Sponsor official statement of financial support | View source |
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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).
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Movement disorders specialists will review the severity of symptoms as blinded raters in the 3th-month and 5th-month follow-up.
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| 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. |
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Change in the patients' symptoms severity measured by changes in the Clinical Global Impressions (CGI) Scale - Severity |
| 3th-month and 5th-month follow-ups |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D003291 | Conversion Disorder |
| ID | Term |
|---|---|
| D013001 | Somatoform Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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