The Effect of Activity Feedback Enabled by Smart Watches During In-patient Stroke Rehabilitation
20 de abril de 2017 actualizado por: Dr Derick Wade, The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine
An International Randomized Clinical Trial of Activity Feedback During In-patient Stroke Rehabilitation Enabled by Smart Watches
The amount of activity completed by individuals within rehabilitation programs, even when units are well staffed, is often far below that required for optimal stroke rehabilitation, and is not individually adapted on a day-to-day basis.
Daily feedback on their activity levels may motivate stroke survivors to engage in greater skills practice and thus outcome after stroke.
To date only a few trials suggests that augmented feedback may be effective.
There is a need for a large pragmatic trial to explore the impact of augmented activity feedback on top of their standard care.
The purpose of this study is to determine the effect of augmented activity feedback by smart watches to support in-patient stroke rehabilitation.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
This study had a feasibility and pilot development phase from September 2015 to April 2016, and then moved into the main study with some changes in design and execution occurring in the light of experience. Its execution has also been constrained by external factors beyond control.
It is in essence asking whether wearing a Smart Watch which gives feedback on activity every two hours, with a specific target tailored to the patient's performance 24 hours earlier will be associated with a higher rate of physical activity than seen in people wearing the same watch without and feedback been given.
The intervention only lasts unto 21 days, but earlier discharge will terminate that patient's participation sooner. A telephone interview at 12 weeks after entry collect data on mobility.
Outcome measures will assess mobility, activity, and health status.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
200
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
-
-
Anhui
-
Hefei, Anhui, Porcelana
- Reclutamiento
- The 2nd Affiliated Hospital to Anhui University of Tranditional Chinese Medicine
-
Contacto:
- Yun Dong, Dr
- Número de teléfono: +86 551 6266 5048
- Correo electrónico: dongyun1003@126.com
-
-
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
18 años a 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Admission for acute/sub-acute in-patient neurorehabilitation of a first stroke at the 2nd affiliated hospital of Anhui University of Traditional Medicine and Acupuncture, Hefei, China.
- Time from onset of stroke to admission for rehabilitation <16 weeks.
- Ability to follow a two stage command; pick up an object, put object on table.
- Independent in mobility prior to admission. Subjects can use any type of assistive device and brace needed.
- Able to understand and repeat information related to the Informed Consent.
Exclusion Criteria:
- Admission for second stroke.
- Subjects who are unable to provide consent due to a cognitive impairment.
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: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Feedback against tailored target
For each two hour epoch, the watch calculate the level of activity for the same epoch the day before, and adds 5% as the new target to be achieved.
|
Participants will wear a smart watch every weekday for nine hours during in-patient rehabilitation to monitor activity levels while receiving their usual care.
In the active group, the watch will summate activity movement in two hour epochs and the target for the day for that epoch is the activity in the same epoch 24 hours earlier, plus 5%.
During an epoch the patient is shown progress towards the target at at the end of an epoch, they will see their final process towards target for that epoch.
|
|
Comparador falso: No Feedback
For participants assigned to the control group, the smart watch will not provide any activity feedback against a target; it simply shows which two hour epoch a person is in.
|
Participants will wear a smart watch every weekday for nine hours during in-patient rehabilitation to monitor activity levels while receiving their usual care.
However the watch face will simply show which epoch a person is in.
The watch will collect the activity in exactly the same way over the day.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Change in activity counts as measured by a triaxial accelerometer from a smart watch from admission to 3 weeks or discharge from rehabilitation
Periodo de tiempo: Baseline, Three weeks or at discharge from in-patient rehabilitation if sooner
|
Baseline, Three weeks or at discharge from in-patient rehabilitation if sooner
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Activity goal attainment as measured and provided by the smart watch
Periodo de tiempo: At three weeks, or discharge if sooner
|
Participants in feedback group receive a preset activity goal based on their previous activity levels at baseline.
The smart watch will then provide graduated encouragement by increasing their activity goal by about 5%.
Every 10-15 minutes the screen lights up and participants can see their activity progress expressed by activity bars (representing 0-100%).
Participants reaching their activity goal is used to measure goal attainment.
|
At three weeks, or discharge if sooner
|
|
Change in walking mobility
Periodo de tiempo: Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
|
Change in walking speed and spatio-temporal characteristics of walking as measured by an inertial sensor on the lower trunk during a 10m walk test.
|
Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
|
|
Fatigue
Periodo de tiempo: Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
|
Fatigue Severity Index
|
Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
|
|
Health status on EQ-5D-5L
Periodo de tiempo: Baseline, Three weeks or discharge from in-patient rehabilitation if sooner, and 12 weeks (by telephone)
|
This scale is used a measure for health status and compromises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression
|
Baseline, Three weeks or discharge from in-patient rehabilitation if sooner, and 12 weeks (by telephone)
|
|
Change in functional mobility as measured by Rivermead Mobility Index (RMI)
Periodo de tiempo: Baseline, Three weeks or discharge from in-patient rehabilitation if sooner, and 12 weeks (by telephone)
|
This scale assesses functional mobility in gait, balance and transfers after stroke
|
Baseline, Three weeks or discharge from in-patient rehabilitation if sooner, and 12 weeks (by telephone)
|
|
Change in cognitive function as measured by The Montreal Cognitive Assessment (MoCA)
Periodo de tiempo: Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
|
This is a screening instrument for to measure mild cognitive dysfunction.
It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.
|
Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
|
|
Change in arm function recovery
Periodo de tiempo: Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
|
Grip dynamometer
|
Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
|
|
Change in performance of activities of daily living as measured by Barthel ADL Index
Periodo de tiempo: Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
|
This scale is used to record what the participant undertakes in personal activities, to establish a degree of independence from any help, physical or verbal.
|
Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
|
|
Change in disability as measured by WHO Disability Assessment Scale (12 item version)
Periodo de tiempo: Baseline, Three weeks or discharge from in-patient rehabilitation if sooner, and 12 weeks
|
This scale provides a global measure of disability covering 6 domains: cognition, mobility, self-care, getting along, life activities, and participation
|
Baseline, Three weeks or discharge from in-patient rehabilitation if sooner, and 12 weeks
|
|
Adverse events
Periodo de tiempo: At three weeks, or discharge if sooner and at 12 weeks
|
Self-reported adverse events
|
At three weeks, or discharge if sooner and at 12 weeks
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Colaboradores
Investigadores
- Investigador principal: Derick T Wade, MD, Oxford Brookes University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Lawrie S, Dong Y, Steins D, Xia Z, Esser P, Sun S, Li F, Amor JD, James C, Izadi H, Cao Y, Wade D, Mayo N, Dawes H; Smart Watch Activity Feedback Trial Committee (SWAFT). Evaluation of a smartwatch-based intervention providing feedback of daily activity within a research-naive stroke ward: a pilot randomised controlled trial. Pilot Feasibility Stud. 2018 Oct 6;4:157. doi: 10.1186/s40814-018-0345-x. eCollection 2018.
- Dong Y, Steins D, Sun S, Li F, Amor JD, James CJ, Xia Z, Dawes H, Izadi H, Cao Y, Wade DT; Smart watch activity feedback trial committee (SWAFT). Does feedback on daily activity level from a Smart watch during inpatient stroke rehabilitation increase physical activity levels? Study protocol for a randomized controlled trial. Trials. 2018 Mar 9;19(1):177. doi: 10.1186/s13063-018-2476-z.
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
1 de septiembre de 2015
Finalización primaria (Anticipado)
1 de enero de 2018
Finalización del estudio (Anticipado)
1 de agosto de 2018
Fechas de registro del estudio
Enviado por primera vez
30 de septiembre de 2015
Primero enviado que cumplió con los criterios de control de calidad
23 de octubre de 2015
Publicado por primera vez (Estimar)
27 de octubre de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
21 de abril de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
20 de abril de 2017
Última verificación
1 de marzo de 2017
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ChiECRCT-20150034
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan IPD
In the unlikely event that someone asks, it will probably be shared but so far (March 2017) there is no plan
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. .