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

20. april 2017 oppdatert av: 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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Forventet)

200

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Kina
    • Anhui
      • Hefei, Anhui, Kina
        • Rekruttering
        • The 2nd Affiliated Hospital to Anhui University of Tranditional Chinese Medicine
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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.
Sham-komparator: 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.
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Change in activity counts as measured by a triaxial accelerometer from a smart watch from admission to 3 weeks or discharge from rehabilitation
Tidsramme: Baseline, Three weeks or at discharge from in-patient rehabilitation if sooner
Baseline, Three weeks or at discharge from in-patient rehabilitation if sooner

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Activity goal attainment as measured and provided by the smart watch
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Samarbeidspartnere

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

Etterforskere

  • Hovedetterforsker: Derick T Wade, MD, Oxford Brookes University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2015

Primær fullføring (Forventet)

1. januar 2018

Studiet fullført (Forventet)

1. august 2018

Datoer for studieregistrering

Først innsendt

30. september 2015

Først innsendt som oppfylte QC-kriteriene

23. oktober 2015

Først lagt ut (Anslag)

27. oktober 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. april 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. april 2017

Sist bekreftet

1. mars 2017

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ChiECRCT-20150034

Plan for individuelle deltakerdata (IPD)

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UBESLUTTE

IPD-planbeskrivelse

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

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Nei

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