The Effect of Activity Feedback Enabled by Smart Watches During In-patient Stroke Rehabilitation
20 de abril de 2017 atualizado 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.
Visão geral do estudo
Status
Desconhecido
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Antecipado)
200
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Anhui
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Hefei, Anhui, China
- Recrutamento
- The 2nd Affiliated Hospital to Anhui University of Tranditional Chinese Medicine
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Contato:
- Yun Dong, Dr
- Número de telefone: +86 551 6266 5048
- E-mail: dongyun1003@126.com
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 75 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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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.
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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.
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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.
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Change in activity counts as measured by a triaxial accelerometer from a smart watch from admission to 3 weeks or discharge from rehabilitation
Prazo: Baseline, Three weeks or at discharge from in-patient rehabilitation if sooner
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Baseline, Three weeks or at discharge from in-patient rehabilitation if sooner
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Activity goal attainment as measured and provided by the smart watch
Prazo: At three weeks, or discharge if sooner
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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.
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At three weeks, or discharge if sooner
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Change in walking mobility
Prazo: Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
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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.
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Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
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Fatigue
Prazo: Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
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Fatigue Severity Index
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Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
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Health status on EQ-5D-5L
Prazo: Baseline, Three weeks or discharge from in-patient rehabilitation if sooner, and 12 weeks (by telephone)
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This scale is used a measure for health status and compromises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression
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Baseline, Three weeks or discharge from in-patient rehabilitation if sooner, and 12 weeks (by telephone)
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Change in functional mobility as measured by Rivermead Mobility Index (RMI)
Prazo: Baseline, Three weeks or discharge from in-patient rehabilitation if sooner, and 12 weeks (by telephone)
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This scale assesses functional mobility in gait, balance and transfers after stroke
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Baseline, Three weeks or discharge from in-patient rehabilitation if sooner, and 12 weeks (by telephone)
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Change in cognitive function as measured by The Montreal Cognitive Assessment (MoCA)
Prazo: Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
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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.
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Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
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Change in arm function recovery
Prazo: Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
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Grip dynamometer
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Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
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Change in performance of activities of daily living as measured by Barthel ADL Index
Prazo: Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
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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.
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Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
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Change in disability as measured by WHO Disability Assessment Scale (12 item version)
Prazo: Baseline, Three weeks or discharge from in-patient rehabilitation if sooner, and 12 weeks
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This scale provides a global measure of disability covering 6 domains: cognition, mobility, self-care, getting along, life activities, and participation
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Baseline, Three weeks or discharge from in-patient rehabilitation if sooner, and 12 weeks
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Adverse events
Prazo: At three weeks, or discharge if sooner and at 12 weeks
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Self-reported adverse events
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At three weeks, or discharge if sooner and at 12 weeks
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Colaboradores
Investigadores
- Investigador principal: Derick T Wade, MD, Oxford Brookes University
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de setembro de 2015
Conclusão Primária (Antecipado)
1 de janeiro de 2018
Conclusão do estudo (Antecipado)
1 de agosto de 2018
Datas de inscrição no estudo
Enviado pela primeira vez
30 de setembro de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
23 de outubro de 2015
Primeira postagem (Estimativa)
27 de outubro de 2015
Atualizações de registro de estudo
Última Atualização Postada (Real)
21 de abril de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
20 de abril de 2017
Última verificação
1 de março de 2017
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ChiECRCT-20150034
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
Descrição do plano IPD
In the unlikely event that someone asks, it will probably be shared but so far (March 2017) there is no plan
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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