The Effect of Activity Feedback Enabled by Smart Watches During In-patient Stroke Rehabilitation
20 april 2017 uppdaterad 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.
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
200
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Anhui
-
Hefei, Anhui, Kina
- Rekrytering
- The 2nd Affiliated Hospital to Anhui University of Tranditional Chinese Medicine
-
Kontakt:
- Yun Dong, Dr
- Telefonnummer: +86 551 6266 5048
- E-post: dongyun1003@126.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Sham Comparator: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Change in activity counts as measured by a triaxial accelerometer from a smart watch from admission to 3 weeks or discharge from rehabilitation
Tidsram: Baseline, Three weeks or at discharge from in-patient rehabilitation if sooner
|
Baseline, Three weeks or at discharge from in-patient rehabilitation if sooner
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Activity goal attainment as measured and provided by the smart watch
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Derick T Wade, MD, Oxford Brookes University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 september 2015
Primärt slutförande (Förväntat)
1 januari 2018
Avslutad studie (Förväntat)
1 augusti 2018
Studieregistreringsdatum
Först inskickad
30 september 2015
Först inskickad som uppfyllde QC-kriterierna
23 oktober 2015
Första postat (Uppskatta)
27 oktober 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
21 april 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 april 2017
Senast verifierad
1 mars 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ChiECRCT-20150034
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
OBESLUTSAM
IPD-planbeskrivning
In the unlikely event that someone asks, it will probably be shared but so far (March 2017) there is no plan
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .