- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT06588673
Arteterapia en la parálisis supranuclear progresiva
Arteterapia en la parálisis supranuclear progresiva: estudio del efecto sobre la calidad de la atención
Our aim is to study the effect of art therapy for people with PSP, with a focus on alleviating the symptoms associated with PSP, enhancing the overall quality of life for patients, and reducing caregiver stress. Overall, through our collaborative efforts on this study, we hope to unlock the benefits of art therapy for this vulnerable patient population, ultimately improving their overall well-being and enhancing their quality of life.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Progressive Supranuclear Palsy (PSP) is typically manifested by a multitude of distressing symptoms, including bradyphrenia and bradykinesia, speech dyspraxia, visual problems, and postural instability with high risk of falls. These symptoms not only inflict physical hardships on patients but also have profound emotional and psychological implications. Thus, a decline in self-esteem, a reduction in the quality of life, and heightened stress for caregivers is remarkable. In recent years, art therapy has garnered attention as a potentially effective intervention for individuals grappling with neurodegenerative disorders. Art therapy encompasses a wide array of activities that promote cognitive and motor skills, including shape recognition, motion perception, sensory-motor integration, abstraction, and eye-hand coordination. As a result, it holds promise as a therapeutic tool for addressing the intricate challenges faced by PSP people. Although art therapy has demonstrated positive outcomes in enhancing visual cognitive skills, refining visual exploration strategies, and bolstering general motor function in Parkinson's disease, its potential in the context of PSP remains largely unexplored. Given the unique symptomatology and emotional toll of PSP, patients suffering from this condition stand to benefit significantly from the healing and therapeutic effects of art therapy. In light of these considerations, our proposal aims to bridge this knowledge gap by implementing and rigorously studying the impact of art therapy on PSP patients. Our aim is to investigate the effect of art therapy for people with PSP, with a focus on alleviating the symptoms associated with PSP, enhancing the overall quality of life for patients, and reducing caregiver stress. Overall, through our collaborative efforts on this study, we hope to unlock the benefits of art therapy for this vulnerable patient population, ultimately improving their overall well-being and enhancing their quality of life.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Tennessee
-
Nashville, Tennessee, Estados Unidos, 37232
- Vanderbilt University Medical Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Diagnosis of progressive supranuclear palsy
- Have the cognitive ability to provide informed consent
Exclusion Criteria:
- Primary neurological diagnosis other than progressive supranuclear palsy
- Cognition too impaired to provide informed consent
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: Art Therapy
psp patients enrolled into study. |
Art therapy at Art Therapy Studio, a well-established recommended art therapy leader since 1967 with extensive experience in virtual therapy for patients with medical needs. Cheryl Pete, MA ATR-BC, a board-certified art therapist and the Clinical Director will complete the art therapy sessions. The art therapy will be a 1-hour sessions, once a week for a total of 8 weeks (or 8 sessions). Cheryl Pete's role will solely involve providing a service. Chery will complete the Art Therapy according to her standard practices. Cheryl's Art Therapy will not be altered in any way as a part of this research study. Cheryl will not collect any research data. As research participants are referred to Cheryl for the Art Therapy, the research participant's name and contact information will be shared. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
PSP-QoL (Progressive Supranuclear Palsy Qualify of Life Scale)
Periodo de tiempo: 8-10 weeks
|
Self-reported quality of life rating scale comprising of 28 items in six categories: daily activities (by history), behavior, bulbar, ocular motor, limb motor and gait/midline. Scores range from 0 to 100, each item graded 0-2 (six items) or 0-4 (22 items). The lower the total score the better the quality of life. |
8-10 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
PHQ-9 (Patient Health Questionnaire-9)
Periodo de tiempo: 8-10 weeks
|
Self-reported depression rating scale comprising of 9 items. The lower the total score means that depression is absent or minimal. |
8-10 weeks
|
|
NPI (Neuropsychiatric Inventory)
Periodo de tiempo: 8-10 weeks
|
Scale that is completed by the caregiver. The scale is comprised of 12 items and will evaluate behavioral areas commonly affected in patients with dementia. The lower the total score means that behavior is intact |
8-10 weeks
|
|
Zarit Caregiver Burden Scale
Periodo de tiempo: 8-10 weeks
|
Scale that is completed by the caregiver. The scale is comprised of 22 items and will evaluate the caregiver's level of burden. The lower the total score means that the burden is absent. |
8-10 weeks
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Cucca A, Acosta I, Berberian M, Lemen AC, Rizzo JR, Ghilardi MF, Quartarone A, Feigin AS, Di Rocco A, Biagioni MC. Visuospatial exploration and art therapy intervention in patients with Parkinson's disease: an exploratory therapeutic protocol. Complement Ther Med. 2018 Oct;40:70-76. doi: 10.1016/j.ctim.2018.07.011. Epub 2018 Jul 27.
- Yu J, Rawtaer I, Goh LG, Kumar AP, Feng L, Kua EH, Mahendran R. The Art of Remediating Age-Related Cognitive Decline: Art Therapy Enhances Cognition and Increases Cortical Thickness in Mild Cognitive Impairment. J Int Neuropsychol Soc. 2021 Jan;27(1):79-88. doi: 10.1017/S1355617720000697. Epub 2020 Aug 7.
- Cucca A, Di Rocco A, Acosta I, Beheshti M, Berberian M, Bertisch HC, Droby A, Ettinger T, Hudson TE, Inglese M, Jung YJ, Mania DF, Quartarone A, Rizzo JR, Sharma K, Feigin A, Biagioni MC, Ghilardi MF. Art therapy for Parkinson's disease. Parkinsonism Relat Disord. 2021 Mar;84:148-154. doi: 10.1016/j.parkreldis.2021.01.013. Epub 2021 Jan 23.
- Perez Matos JA, Richard A, Spee BT, Pelowski M. Neurodegenerative diseases, art and creativity: therapeutic implications. Neurodegener Dis Manag. 2021 Jun;11(3):187-192. doi: 10.2217/nmt-2021-0012. Epub 2021 Jun 3. No abstract available.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades de los ojos
- Tauopatías
- Enfermedades neurodegenerativas
- Trastornos del movimiento
- Enfermedades de los ganglios basales
- Enfermedades de los nervios craneales
- Oftalmoplejía
- Trastornos de la motilidad ocular
- Parálisis
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Parálisis Supranuclear Progresiva
Otros números de identificación del estudio
- 240791
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
All data for the project will be coded. All coded IPD with be shared between Baylor and Vanderbilt will also be coded. Baylor University Neurology department is conducting their own PSP art therapy study in conjunction with VUMC. Each site will obtain their own local IRB approval.
Marco de tiempo para compartir IPD
Within 1 week of enrolling our first participant IPD will be shared. No expiration of this data.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .