- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07923201
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Evaluating Functional Outcomes and Clinical Feasibility of the Zeen Mobility Device in Outpatient Rehabilitation
The goal of this clinical trial is to learn whether the Zeen Mobility Device can improve mobility and function during outpatient rehabilitation for adults with mobility impairments. The study will also evaluate the safety of the device and how easy it is for participants and therapists to use during routine therapy.
The main questions it aims to answer are:
- Does using the Zeen Mobility Device improve walking, standing, transfers, and daily function compared with a participant's usual mobility device?
- Can the Zeen Mobility Device be safely incorporated into outpatient rehabilitation?
- How satisfied are participants and therapists with using the device during therapy?
Researchers will compare participants' performance using the Zeen Mobility Device with their performance using their usual mobility device, such as a walker or wheelchair. Participants will serve as their own comparison group.
Participants will:
- Complete a baseline assessment before starting the study, a midpoint assessment after 4 treatment sessions, and a final assessment after 8 treatment sessions.
- Attend 8 outpatient physical therapy sessions that include use of the Zeen Mobility Device.
- Use the Zeen Mobility Device for at least 15 minutes during each study visit for balance, mobility, walking, transfer, or standing activities selected by their therapist.
- Complete mobility and functional tests using both the Zeen Mobility Device and their usual mobility device at each assessment visit.
- Provide feedback about their experience using the device while researchers monitor safety and any device-related problems.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: George Kopiloff
- Número de teléfono: 3500 909-596-7733
- Correo electrónico: GKopiloff@casacolina.org
Ubicaciones de estudio
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-
California
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Pomona, California, Estados Unidos, 91767
- Casa Colina Hospital and Centers for Healthcare
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Contacto:
- George Kopiloff
- Número de teléfono: 3500 909-596-7733
- Correo electrónico: gkopiloff@casacolina.org
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
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Be 18 years of age or older
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Be enrolled in outpatient PT and/or OT
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Demonstrate mobility limitations appropriate for Zeen use
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Meet the following functional thresholds:
- 6MWT: 800-1800 feet
- 10MWT: 0.4-1.3 m/s
- Grip strength ≥1 pound in at least one hand
- Knee extension strength ≥ MMT grade 3/5
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Be capable of providing informed consent
Exclusion Criteria:
- Severe cognitive impairment
- Medical instability that would preclude participation
- Inability to safely participate in mobility assessments
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Zeen Intervention Group
|
Participants will:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Timed Up and Go
Periodo de tiempo: Baseline, 2 weeks, and 4 weeks
|
The Timed Up and Go Test is a clinical tool used to evaluate functional mobility, balance, walking ability, and fall risk in older adults and individuals with neurological or musculoskeletal conditions. Scoring is measured in seconds to complete the task. Higher scores indicate worse mobility, balance, and walking ability. |
Baseline, 2 weeks, and 4 weeks
|
|
10 Meter Walk Test
Periodo de tiempo: Baseline, 2 weeks, and 4 weeks
|
The 10 Meter Walk Test is an assessment of a person's walking speed as they walk 10 meters, measured in seconds. A higher score indicates worsening balance and walking capacity, and is associated with poorer home and community access and increased fall risk |
Baseline, 2 weeks, and 4 weeks
|
|
6 Minute Walk Test
Periodo de tiempo: Baseline, 2 weeks, and 4 weeks
|
The 6 Minute Walk Test is an assessment of a person's walking endurance as they walk during a 6-minute period, measured in total distance walked in meters. A higher score is associated with better walking endurance and capacity, and is associated with better home and community access and decreased fall risk |
Baseline, 2 weeks, and 4 weeks
|
|
Barthel Index
Periodo de tiempo: Baseline, 2 weeks, and 4 weeks
|
The Barthel Index is an ordinal clinical scale that measures a patient's level of functional independence in 10 basic activities of daily living and mobility. The scale calculates 10 items into a point total, from 0 to 100, with a higher score indicating a greater level of independence and decreased need for nursing and caregiver support. |
Baseline, 2 weeks, and 4 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Patient Satisfaction and Exertion Survey
Periodo de tiempo: Baseline, 2 weeks, and 4 weeks
|
Participants will report satisfaction with the device on a 5-point Likert Scale, or a 10-point scale, including:
Total scores range from 9 to 50, with a higher score indicating more difficulty with the device, and decreased satisfaction. |
Baseline, 2 weeks, and 4 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Emily Rosario, PhD, Casa Colina Hospital and Centers for Healthcare
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
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
- Sinucleinopatías
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Heridas y Lesiones
- Enfermedades autoinmunes
- Enfermedades del sistema inmunológico
- Enfermedades Autoinmunes Desmielinizantes, SNC
- Enfermedades Autoinmunes del Sistema Nervioso
- Enfermedades desmielinizantes
- Enfermedades neurodegenerativas
- Trastornos del movimiento
- Trauma, Sistema Nervioso
- Trastornos Parkinsonianos
- Enfermedades de los ganglios basales
- Enfermedades de la médula espinal
- Carrera
- Esclerosis múltiple
- Enfermedad de Parkinson
- Lesiones de la médula espinal
Otros números de identificación del estudio
- ZeenMobility
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.
producto fabricado y exportado desde los EE. UU.
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