Evaluation of a Tele-Rehabilitation Service Program
31 de mayo de 2018 actualizado por: Allen Brown, Mayo Clinic
Joint Gertner ReAbility Online and Mayo Clinic Feasibility Study: Evaluation of a Tele-Rehabilitation Service Program
Is a unique tele-rehabilitation service directed at treating upper limb weakness due to stroke feasible to provide at Mayo Clinic and are the individuals with stroke and the clinicians providing the care satisfied with the process?
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
Participants will be identified from Mayo Clinic Division of Brain Rehabilitation's existing clinical practice and recruited either in person or by using a phone script.
Eligible participants will have 2 in-person clinical assessments, one before the intervention and one concluding the protocol. The first clinical assessment will involve introducing and familiarizing the participant with the study procedure, demonstrating and practicing with the system, and obtaining baseline clinical measures. During this first session the participant's technical skills and home equipment capabilities will be assessed and any assistance needed for establishing the technology in their home will be determined and provided. The second clinical assessment will include acquiring post-intervention clinical and outcome measures. Intervention duration will be 3 months. During the study period, each participant will receive online treatment for up to 45 minutes (in order to have net 30 min clinical time) twice per week. During these sessions, the clinician will teach system interaction including integrating feedback, instruct in system intervention activities and assure participant competence in system use, and adjust the level of difficulty in each activity according to the participant's abilities and needs. After the first month of intervention, the participant may be given permission by the therapist to train with the system for no more than 40 minutes per day. Such self-training opportunities are in addition to the twice weekly online sessions with the therapist.
Tipo de estudio
Intervencionista
Inscripción (Actual)
10
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic in Rochester
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
21 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion
- >12 months after stroke
- Age 21-80 years
- A minimum of 45 degrees of flexion in the affected shoulder
- Active extension of the affected elbow to 150 degrees
- Independent sitting balance
- Able to understand simple instructions
- Lives within a 100 mile radius and able to attend two clinical assessments at Mayo Clinic
- Able to install the tele-rehabilitation software with minimal remote technical support
- Available caregiver as needed who has basic technical understanding of computer operation
- i3 processor based PC; 26" monitor; Windows 7 or 8 operating system; Internet connection of at least 10Mbps.
Exclusion
- Medical conditions that may limit physical activity at the level of low intensity cardio-vascular exercise
- Any contraindication related to the integrity of the musculoskeletal system
- Active malignancy
- Uncontrolled epilepsy
- Global aphasia
- Severe apraxia
- Severe ataxia
- Unilateral spatial neglect
- Chronic pain
- Pregnancy
- Adults lacking capacity
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿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: Tele-motion rehabilitation system
Clinicians remotely monitor subjects' motor performance using Microsoft Kinect 3D sensor tracking system in their home to record their upper limb and trunk movements as they participate in a variety of functional tasks and motor activities, which are directed by their interaction with a monitor screen in their home using uniquely adapted software to integrate key rehabilitation intervention principles.
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Tele-motion rehabilitation system: Interventions include functional therapeutic exercise and real-time feedback.
Clinicians remotely monitor subjects' motor performance using Microsoft Kinect 3D sensor tracking system in their home to record their upper limb and trunk movements as they participate in a variety of functional tasks and motor activities, which are directed by their interaction with a monitor screen in their home using uniquely adapted software to integrate key rehabilitation intervention principles.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Satisfaction Questionnaire
Periodo de tiempo: 3 months
|
Clinician and participant satisfaction questionnaire
|
3 months
|
|
System Usability Scale
Periodo de tiempo: 3 months
|
Clinician and participant usability questionnaire
|
3 months
|
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Qualitative measure of technology/communications problems
Periodo de tiempo: 3 months
|
Self report text of problems and difficulty with experimental technology and communication from participants and clinicians
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3 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Upper limb (shoulder, elbow) range of motion
Periodo de tiempo: Baseline and at 3 months
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Upper limb (shoulder, elbow) range of motion of the participant as measured by a goniometer
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Baseline and at 3 months
|
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Fugl- Meyer Scale
Periodo de tiempo: Baseline and at 3 months
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Fugl- Meyer Assessment for the participant's upper limb
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Baseline and at 3 months
|
|
Motor Activity Log (MAL)
Periodo de tiempo: Baseline and at 3 months
|
Individuals are asked to rate Quality of Movement (QOM) and Amount of Movement (AOM) during 30 daily functional tasks (original MAL), 28 functional tasks (MAL 28) or 14 tasks (MAL 14).
Target tasks include object manipulation (e.g.
pen, fork, comb, and cup) as well as the use of the arm during gross motor activities (e.g.
transferring to a car, steadying oneself during standing, pulling a chair into a table while sitting).
Items scored on a 6-point ordinal scale.
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Baseline and at 3 months
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Measures from the ReAbility Online system of participant and clinician activity
Periodo de tiempo: Weekly through 3-month study period
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Time of practice by participant as measured by the ReAbility Online system
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Weekly through 3-month study period
|
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Task performance scores
Periodo de tiempo: Weekly through 3-month study period
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Participant task performance scores as measured by the ReAbility Online system
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Weekly through 3-month study period
|
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Upper limb range of motion
Periodo de tiempo: Weekly through 3-month study period
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Upper limb range of motion of participant as measured by the ReAbility Online system
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Weekly through 3-month study period
|
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Number of compensatory movements
Periodo de tiempo: Weekly through 3-month study period
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Number of compensatory movements as measured by the ReAbility Online system
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Weekly through 3-month study period
|
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Time online
Periodo de tiempo: Weekly through 3-month study period
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Time online of participant and clinician as measured by the ReAbility Online system
|
Weekly through 3-month study period
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Allen Brown, MD, Mayo Clinic
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
6 de noviembre de 2016
Finalización primaria (Actual)
1 de abril de 2018
Finalización del estudio (Actual)
1 de abril de 2018
Fechas de registro del estudio
Enviado por primera vez
12 de octubre de 2015
Primero enviado que cumplió con los criterios de control de calidad
14 de octubre de 2015
Publicado por primera vez (Estimar)
16 de octubre de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de junio de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
31 de mayo de 2018
Última verificación
1 de mayo de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 15-006308
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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. .
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