The Effect of Activity Feedback Enabled by Smart Watches During In-patient Stroke Rehabilitation
2017년 4월 20일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (예상)
200
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Anhui
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Hefei, Anhui, 중국
- 모병
- The 2nd Affiliated Hospital to Anhui University of Tranditional Chinese Medicine
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연락하다:
- Yun Dong, Dr
- 전화번호: +86 551 6266 5048
- 이메일: dongyun1003@126.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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가짜 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Activity goal attainment as measured and provided by the smart watch
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Derick T Wade, MD, Oxford Brookes University
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2015년 9월 1일
기본 완료 (예상)
2018년 1월 1일
연구 완료 (예상)
2018년 8월 1일
연구 등록 날짜
최초 제출
2015년 9월 30일
QC 기준을 충족하는 최초 제출
2015년 10월 23일
처음 게시됨 (추정)
2015년 10월 27일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 4월 21일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 4월 20일
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2017년 3월 1일
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