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BALCAPHead-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

BALCAP prosthesis

Dispositivo
Quiénes están siendo reclutados

Mareo+6

+ Enfermedades del oído

+ Enfermedades del Laberinto

De 21 a 89 años
+7 Criterios de eligibilidad
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Otro tipo de estudio

Intervencional
Inicio del estudio: octubre de 2017
Ver detalles del protocolo

Resumen

Patrocinador PrincipalBarron Associates, Inc.
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de octubre de 2017

Fecha en la que se inscribió al primer participante.

The goal of this study is to evaluate a tactile prosthesis that provide individuals who have demonstrated chronic imbalance with help to maintain a correct sense of orientation with respect to the gravity and improve posture control. Chronic imbalance leads to significant problems. This study is designed to evaluate a device which can potentially improve the balance of these patients. The participant will be asked to come to Washington University on three occasions for approximately 2 hours. Between visits, they will be asked to use the device daily (intervention condition) or to not use the device (control condition) for a prescribed period of time doing different activities. They will be provided written instructions from a physical therapist that will be determined by their individual ability. The activities will be typical exercises that are given to people with balance disorders. After 6 weeks of home use, participants will return for the second visit, and will repeat the evaluation. They will then return home and complete the either the control or intervention condition (which was not done the first time) in a crossover design. On their first visit (week 0; baseline) participants will be asked to complete the same kind of tests that evaluated the function of their balance system at the time of their diagnosis. They will have their eye movements recorded using goggles and an infra-red camera while the prosthesis is in place and providing vibration feedback. Computerized Dynamic Posturography (CDP) testing will require them to stand on a platform and perform tests (20 seconds each) with their eyes open or closed, with the platform moving or still, and/or with the visual surround either stable or moving. They will be fitted with a safety harness that will keep them from falling. Next the investigators will evaluate their ability to perform movement tasks while walking (walking down the hall, walking down the hall avoiding objects, changing speeds while walking, going up and down stairs etc). They will walk a 25-foot distance at a comfortable gait speed, and again at a maximum gait speed. Lastly, they will be asked to fill out questionnaires. On their second and last visit, they will repeat the evaluations that were performed during the first visit.

Título OficialHead-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability
Patrocinador PrincipalBarron Associates, Inc.
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 13 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Otro Tipo de Estudio

Algunos estudios exploran temas que no encajan en una categoría específica. Pueden incluir investigaciones innovadoras, nuevas tecnologías o áreas emergentes en el ámbito de la salud.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

De 21 a 89 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

MareoEnfermedades del oídoEnfermedades del LaberintoManifestaciones NeurológicasEnfermedades OtorrinolaringológicasTrastornos de la SensaciónSignos y SíntomasCondiciones Patológicas, Signos y SíntomasEnfermedades Vestibulares

Criterios

5 criterios de inclusión requeridos para participar
Ambulatory

Chronic imbalance for at least 1 year

Have reached a functional performance plateau with respect to balance performance

Have a DGI score of <19

Mostrar Más Criterios

2 criterios de exclusión impiden participar
Subjects who are unwilling or unable to adhere to all study requirements, including completion of the training period, evaluation tests, and return to clinic for a follow-up visit.

Women who are pregnant (women will self-report possible pregnancy).

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

2 grupos de intervención están designados en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
Participants performed exercises daily at home wearing the BALCAP prosthesis for 6 weeks. After 6 weeks, participants performed the control condition (the same exercises without the BALCAP). Tests were performed before and after each 6-week period. Exercises included: (1) standing on a firm surface with feet apart, eyes open and closed; (2) standing on a firm surface with feet together, eyes open and closed; (3) standing on thick footing (e.g., multiple pairs of socks) with feet apart, eyes open and closed; (4) standing on thick footing with feet together, eyes open and closed; (5) standing in a modified Romberg position on a firm surface, eyes open and closed; (6) standing in a Romberg position on a firm surface, eyes open and closed; (7) walking on a firm surface eyes open; (8) walking with thick footing, eyes open; (9) walking with head turns and tilts, eyes open; and (10) walking around a room, with turns and movements other than straight forward walking, eyes open.

Grupo II

Experimental
Participants performed exercises daily at home for 6 weeks without wearing the BALCAP prosthesis (control), followed by another 6 weeks of the same exercises with the BALCAP prosthesis (intervention). Tests were performed before and after each 6 week period. Exercises included: (1) standing on a firm surface with feet apart, eyes open and closed; (2) standing on a firm surface with feet together, eyes open and closed; (3) standing on thick footing (e.g., multiple pairs of socks) with feet apart, eyes open and closed; (4) standing on thick footing with feet together, eyes open and closed; (5) standing in a modified Romberg position on a firm surface, eyes open and closed; (6) standing in a Romberg position on a firm surface, eyes open and closed; (7) walking on a firm surface eyes open; (8) walking with thick footing, eyes open; (9) walking with head turns and tilts, eyes open; and (10) walking around a room, with turns and movements other than straight forward walking, eyes open.

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene una ubicación

Suspendido

Washington University School of Medicine

St Louis, United StatesAbrir Washington University School of Medicine en Google Maps
Completado1 Centros de Estudio