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The Effect of Activity Feedback Enabled by Smart Watches During In-patient Stroke Rehabilitation

20 aprile 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Anticipato)

200

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Cina
    • Anhui
      • Hefei, Anhui, Cina
        • Reclutamento
        • The 2nd Affiliated Hospital to Anhui University of Tranditional Chinese Medicine
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: Feedback against tailored target
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.
Comparatore fittizio: 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.
Comportamentale: No feedback
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Change in activity counts as measured by a triaxial accelerometer from a smart watch from admission to 3 weeks or discharge from rehabilitation
Lasso di tempo: Baseline, Three weeks or at discharge from in-patient rehabilitation if sooner
Baseline, Three weeks or at discharge from in-patient rehabilitation if sooner

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Activity goal attainment as measured and provided by the smart watch
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Collaboratori

Oxford Brookes University
University of Warwick
Oxford International Rehabilitation Foundation and Innovation

Investigatori

  • Investigatore principale: Derick T Wade, MD, Oxford Brookes University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 settembre 2015

Completamento primario (Anticipato)

1 gennaio 2018

Completamento dello studio (Anticipato)

1 agosto 2018

Date di iscrizione allo studio

Primo inviato

30 settembre 2015

Primo inviato che soddisfa i criteri di controllo qualità

23 ottobre 2015

Primo Inserito (Stima)

27 ottobre 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

21 aprile 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 aprile 2017

Ultimo verificato

1 marzo 2017

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ChiECRCT-20150034

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

In the unlikely event that someone asks, it will probably be shared but so far (March 2017) there is no plan

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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