Smart Home-based Technology to Promote Functional Mobility Among Individuals With Parkinson's Disease
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
People with Parkinson's disease (PwP) may experience severe difficulties in mobility that negatively affect their function and Quality of life. Freezing of gait, (FOG) is a brief and sudden inability to initiate walking or move forward, despite an intention to walk. Such episodes are often observed when PwP attempt to turn, cross a narrow space or negotiate obstacles. Rehabilitation interventions for FOG represent the most effective non-pharmacological approach to maintain functional independence and reduce the risk of falls. A key approach is the provision of external cues, defined as sensory stimuli, which facilitate gait initiation and continuation. These external cues are suggested to bypass the dysfunctional movement pathways in the basal ganglia and therefore, are considered effective in alleviating FOG. Cueing can be applied by different modalities; the most common are visual (e.g. spaced lines on the floor) and auditory (e.g. rhythmic metronome beats).
The term smart-home refers to a range of technologies that are designed for and deployed in individual residences, and are equipped with non-invasive, environmental, and physiological sensors. The concept of a "health smart-home" is a variation of smart-home with a focus on assistive technologies to enable the independence and wellness of residents, including the elderly and patients in supervised residences.
In this study, the investigators will be testing the first phase of developing a smart-home technology designed for patients coping with PD to use in their homes and aims to improve gait and assist in prevention of FOG. The aims of this exploratory study are to evaluate the 1) practical feasibility of the technology, 2) patient satisfaction and 3) the effect of the technology on gait. The device was developed by Selfit medical© and included application of light stripes (visual cues) and metronome beats (auditory cues) that are individually adjusted to the participant walking parameters.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Galit Yogev-Seligmann, PhD
- Número de teléfono: +972-4-8288390
- Correo electrónico: galit.yogev@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Naomi Josman, PhD
- Correo electrónico: njosman@univ.haifa.ac.il
Ubicaciones de estudio
-
-
Please Select...
-
Haifa, Please Select..., Israel, 3498838
- Reclutamiento
- Galit Yogev-Seligmann
-
Contacto:
- Galit Yogev-Seligmann
- Número de teléfono: +972-48288390
- Correo electrónico: galit.yogev@gmail.com
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Patient is able to walk independently
- The patient report on daily episodes of FOG as indicated by question #2 in the new FOG questionnaire ("How frequently do you experience freezing episodes?").
- Score>18 on the Telephone Version of the Mini-Mental State Examination (TMMSE)
- Intact hearing and vision by self-declaration
Exclusion criteria
• The patient suffer of any neurological condition other than Parkinson's disease.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Effect of smart-home technology on step length (cm)
Periodo de tiempo: through study completion, an average of 1 year
|
Step length (cm) is assessed during the three walking conditions in order to evaluate the effect of the cueing (visual and auditory) applied on gait. Data is collected by the Kinect sensor. |
through study completion, an average of 1 year
|
|
Effect of smart-home technology on step time (sec) are
Periodo de tiempo: Through study completion, an average of 1 year
|
Step time (sec) is assessed during the three walking conditions in order to evaluate the effect of the cueing (visual and auditory) applied on gait. Data is collected by the Kinect sensor. |
Through study completion, an average of 1 year
|
|
Feasibility and participants' satisfaction semi-structured interview
Periodo de tiempo: through study completion, an average of 1 year
|
Following the walking session, participants answered questions in a semi-structured interview:
|
through study completion, an average of 1 year
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Galit Yogev-Seligmann, PhD, University of Haifa
Publicaciones y enlaces útiles
Publicaciones Generales
- Nieuwboer A, Rochester L, Herman T, Vandenberghe W, Emil GE, Thomaes T, Giladi N. Reliability of the new freezing of gait questionnaire: agreement between patients with Parkinson's disease and their carers. Gait Posture. 2009 Nov;30(4):459-63. doi: 10.1016/j.gaitpost.2009.07.108. Epub 2009 Aug 5.
- Keus HSJ, Munneke M, G. M. et al. European Physiotherapy Guidline for Parkinson's Disease. (2014).
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GALITYS
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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. .