Post-Acute-Stroke RehabilitationNCT04997408
Effectiveness of a Wearable Device-based Assisted Post-stroke Rehabilitation System
A study testing Customized exercise app and In-person therapist-supervised rehabilitation in people with Post-Acute-Stroke Rehabilitation, run by Landseed Hospital.
Trial summary
Multidisciplinary rehabilitation facilitates functional recovery after stroke, and adherence to rehabilitation guidelines is associated with improved outcomes. We assessed the efficacy of a wearable device-assisted rehabilitation system in addition to conventional therapy compared to conventional therapy alone. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Post-Acute-Stroke Rehabilitation
- What is being tested?
- Customized exercise app and In-person therapist-supervised rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide signed informed consent prior to study entry and understand the nature of this study and agree to adhere to all study protocol requirements.
- Males and females 20-75 years of age at the time of signing the informed consent
- Patients with first-ever acute ischemic or hemorrhagic stroke diagnosed by a neurologist or neurosurgeon within 4-12 weeks of onset,
- A baseline modified Rankin Scale score 2-4 on enrollment,
- A designated caregiver for each patient willing to assist the patient to be engaged in WEAR using the mobile embedded with APP.
Who cannot join
- Planning to have further rehabilitation in other hospital and could be followed up in the participating hospital.
- The caregiver of patients not willing to assist patients to be engaged in WEAR.
About this study
Official title: The Cost-effectiveness Analysis of a Wearable Device-based Assisted Rehabilitation System for Discharged Patient With Stroke
Multidisciplinary rehabilitation facilitates functional recovery after stroke, and adherence to rehabilitation guidelines is associated with improved outcomes. We assessed the efficacy of a wearable device-assisted rehabilitation system in addition to conventional therapy compared to conventional therapy alone.
A total of 127 eligible acute stroke inpatients were enrolled. There were 76 males (59.8%). The mean age of the participants was 57.45 years; 63 and 64 participants were randomized to the WG and CG, respectively. Both groups showed significant improvements in mRS scores at 90 days (WG: -0.68 [95% confidence interval (CI), -0.94 to -0.42]; CG: -0.56 [95% CI, -0.74 to -0.38]; P<0.0001), but only the WG had significant improvements between 30 and 90 days (-0.36; 95% CI, -0.72, -0.007; P=0.049). Both groups had significant improvements in secondary outcomes at 90 days, but there was no difference between groups.
Read the detailed description
Stroke remains the leading cause of chronic physical disability worldwide and the second most common cause of acute mortality despite great progress in acute stroke treatment during the past decades. Adherence to rehabilitation guidelines after acute stroke is associated with improved outcomes. Current stroke guidelines recommend early and continuous rehabilitation to facilitate functional recovery and a good prognosis, and more than two-thirds of stroke patients are encouraged to participate in outpatient rehabilitation programs after hospital discharge. The efficacy of rehabilitation might be enhanced by increasing the rehabilitation time using mobile communication devices (telerehabilitation). Moreover, the use of telerehabilitation should be emphasized during the era of coronavirus disease 2019 (COVID-19), when medical resources are limited and in-person contact is restricted.
During the Wearable-Assisted Rehabilitation (WEAR) for Stroke (WEAR-Stroke) trial, we aimed to investigate the efficacy of adding a 30-minute smartphone-assisted or smartwatch-assisted session to conventional in-person rehabilitation.
Several innovative interventions have been introduced beside the conventional rehabilitation because of increasing awareness of the brain's regenerative potential and advances of technology by utilizing visual feedback, transcranial magnetic stimulation and robotics. An alternative way of delivering post-stroke rehabilitation, telerehabilitation, has been proposed by information and communication technologies. The devices could detect, store and upload their physical activity recorded in the sensor-embedded mobile devices of smart watches and smartphones, with connection to the internet and get real-time feedback by the computation. The market penetration of smart mobile devices is rapidly rising in every industrial sector and professional field. The smartphone software applications (apps) are becoming increasingly popular for both health care consumers and providers. The investigators designed a customizable, sensor-driven, internet-based rehabilitation system consisting of a sensing watch, smartphone, a web server and database and users' interface for medical staff. The primary outcome was the mRS scores from baseline (D0) to 30 days (D30), from D0 to 90 days (D90), and from D30 to D90. Acute stroke therapies often use the mRS to assess the functional outcomes and activity limitations.
The secondary outcomes included changes in the following measures at D30 and D90: Barthel index (BI) score for functional recovery of activities of daily living; static and dynamic balance ability (Berg Balance Scale, BBS) scores for 14 functional tasks with varying difficulty, including sitting, standing, transferring, reaching, stepping, and turning, rated using a 5-point scale (range, 0-4) based on the performance of the subject when completing the activity; the scores of the Functional Independence Measure (FIM), which is an 18-item tool that assesses motor domains, such as self-care, continence, transfers, and locomotion, and cognitive domains, such as communication and social cognition (each item was graded from 1 to 7 according to the level of assistance required, with 1 indicating total assistance and 7 indicating complete independence); and scores of the Stream Wolf Motor Function Test (SWMFT), which assesses the ability to perform simple and complex grasp tasks and global arm movements (range, 0-5 points, with 0 indicating unable and 5 indicating normal).
The investigators successfully implement the system developed in the project into three hospitals.
- Conditions
- Post-Acute-Stroke Rehabilitation
- Being tested
- Customized exercise app, In-person therapist-supervised rehabilitation
- Keywords
- Rehabilitation, Stroke, Mobile devices, Telemedicine
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Customized exercise appDevice
A Wearable Device-Based Assisted Post-Stroke Rehabilitation system
In-person therapist-supervised rehabilitationOther
In-person therapist-supervised rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Active comparator | Mobile device-assisted rehabilitation Receives: Device: Customized exercise app; Other: In-person therapist-supervised rehabilitation |
| Control Arm | Active comparator | In-person therapist-supervised rehabilitation Receives: Other: In-person therapist-supervised rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure was changed in mRS, which was defined by scores of 0 to 4 on the modified Rankin scale
The primary outcome measure was changed in mRS, which was defined by scores of 0 to 4 on the modified Rankin scale, a global seven-level measure of functioning in which scores of 0 or 1 indicate a good outcome with no or minimal neurologic symptoms, scores of 2 to 5 indicate a poor outcome with increasing degree of disability, and 6 indicates death.
Measured: Baseline, 30 days and 90 days
Secondary outcomes (4)
Change in Barthel Index (BI) at 30 days, 90 days
Change in Barthel Index (BI) (measure performance in activities of daily living)
Measured: Baseline, 30 days and 90 days
Change in upper limb (UL) function (Stream Wolf Motor Function Test)
Change in upper limb (UL) function (Stream Wolf Motor Function Test: assesses the ability to perform simple and complex grasp tasks and global arm movements. from 0 to 5 points. 0, unable; 5, normal.)
Measured: Baseline, 30 days and 90 days
Change in functional status (Functional Independence Measure)
Change in functional status (Functional Independence Measure-an 18-item tool that assesses function in self-care, continence, mobility, transfers, communication, and cognition. Each item is graded from 1 to 7 according to the level of assistance required. 1, total assistance; 7, complete independence.)
Measured: Baseline, 30 days and 90 days
Change in static and dynamic balance ability (Berg balance scale)
Change in static and dynamic balance ability (Berg balance scale 15- based on 14 functional tasks with varying difficulty, including sitting, standing, transfer, reaching, stepping, and turning. Each task was rated on a five-point scale, ranging from 0 to 4 based on the performance of the subject in completing the activity).
Measured: Baseline, 30 days and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study startNov 2015
- Primary completionNov 2017
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Acute-Stroke RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized study
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Landseed Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Central University, Taiwan, Antai Medical Care Corperation Antai Tian-Sheng Memorial Hospital, Taiwan, Ministry of Health and Welfare, Taiwan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997408
- Sponsor's protocol ID
- MOHW105-TDU-M-212-122008
- Status last verified
- May 2022
- First submitted
- 31 Jul 2021
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ho HJ, Wu LC, Wu EH, Lee SF, Lee TH, Chiang SH, Chen CH, Chen HY, Pan SJ, Chen YW; WEAR-Stroke Study Group. Improving patient outcomes in acute and subacute stroke using a wearable device-assisted rehabilitation system: a randomized controlled trial. J Int Med Res. 2024 Oct;52(10):3000605241281425. doi: 10.1177/03000605241281425.
PubMed 39387211
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cost-effectiveness Analysis of a Wearable Device-based Assisted Rehabilitation System for Discharged Patient With Stroke
- ClinicalTrials.gov ID
- NCT04997408
- Acronym / sponsor ID
- MOHW105-TDU-M-212-122008
- Conditions
- Post-Acute-Stroke Rehabilitation
- Keywords
- Rehabilitation, Stroke, Mobile devices, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Landseed HospitalUniversity, hospital or other
- Collaborators
- National Central University, Taiwan, Antai Medical Care Corperation Antai Tian-Sheng Memorial Hospital, Taiwan, Ministry of Health and Welfare, Taiwan
- Study start
- Nov 2015 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multidisciplinary rehabilitation facilitates functional recovery after stroke, and adherence to rehabilitation guidelines is associated with improved outcomes. We assessed the efficacy of a wearable device-assisted rehabilitation system in addition to conventional therapy compared to conventional therapy alone.
A total of 127 eligible acute stroke inpatients were enrolled. There were 76 males (59.8%). The mean age of the participants was 57.45 years; 63 and 64 participants were randomized to the WG and CG, respectively. Both groups showed significant improvements in mRS scores at 90 days (WG: -0.68 [95% confidence interval (CI), -0.94 to -0.42]; CG: -0.56 [95% CI, -0.74 to -0.38]; P<0.0001), but only the WG had significant improvements between 30 and 90 days (-0.36; 95% CI, -0.72, -0.007; P=0.049). Both groups had significant improvements in secondary outcomes at 90 days, but there was no difference between groups.
Detailed description
Stroke remains the leading cause of chronic physical disability worldwide and the second most common cause of acute mortality despite great progress in acute stroke treatment during the past decades. Adherence to rehabilitation guidelines after acute stroke is associated with improved outcomes. Current stroke guidelines recommend early and continuous rehabilitation to facilitate functional recovery and a good prognosis, and more than two-thirds of stroke patients are encouraged to participate in outpatient rehabilitation programs after hospital discharge. The efficacy of rehabilitation might be enhanced by increasing the rehabilitation time using mobile communication devices (telerehabilitation). Moreover, the use of telerehabilitation should be emphasized during the era of coronavirus disease 2019 (COVID-19), when medical resources are limited and in-person contact is restricted.
During the Wearable-Assisted Rehabilitation (WEAR) for Stroke (WEAR-Stroke) trial, we aimed to investigate the efficacy of adding a 30-minute smartphone-assisted or smartwatch-assisted session to conventional in-person rehabilitation.
Several innovative interventions have been introduced beside the conventional rehabilitation because of increasing awareness of the brain's regenerative potential and advances of technology by utilizing visual feedback, transcranial magnetic stimulation and robotics. An alternative way of delivering post-stroke rehabilitation, telerehabilitation, has been proposed by information and communication technologies. The devices could detect, store and upload their physical activity recorded in the sensor-embedded mobile devices of smart watches and smartphones, with connection to the internet and get real-time feedback by the computation. The market penetration of smart mobile devices is rapidly rising in every industrial sector and professional field. The smartphone software applications (apps) are becoming increasingly popular for both health care consumers and providers. The investigators designed a customizable, sensor-driven, internet-based rehabilitation system consisting of a sensing watch, smartphone, a web server and database and users' interface for medical staff. The primary outcome was the mRS scores from baseline (D0) to 30 days (D30), from D0 to 90 days (D90), and from D30 to D90. Acute stroke therapies often use the mRS to assess the functional outcomes and activity limitations.
The secondary outcomes included changes in the following measures at D30 and D90: Barthel index (BI) score for functional recovery of activities of daily living; static and dynamic balance ability (Berg Balance Scale, BBS) scores for 14 functional tasks with varying difficulty, including sitting, standing, transferring, reaching, stepping, and turning, rated using a 5-point scale (range, 0-4) based on the performance of the subject when completing the activity; the scores of the Functional Independence Measure (FIM), which is an 18-item tool that assesses motor domains, such as self-care, continence, transfers, and locomotion, and cognitive domains, such as communication and social cognition (each item was graded from 1 to 7 according to the level of assistance required, with 1 indicating total assistance and 7 indicating complete independence); and scores of the Stream Wolf Motor Function Test (SWMFT), which assesses the ability to perform simple and complex grasp tasks and global arm movements (range, 0-5 points, with 0 indicating unable and 5 indicating normal).
The investigators successfully implement the system developed in the project into three hospitals.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomized study
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Active comparator | Device: Customized exercise app, Other: In-person therapist-supervised rehabilitationMobile device-assisted rehabilitation |
| Control Arm | Active comparator | Other: In-person therapist-supervised rehabilitationIn-person therapist-supervised rehabilitation |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to provide signed informed consent prior to study entry and understand the nature of this study and agree to adhere to all study protocol requirements.
- Males and females 20-75 years of age at the time of signing the informed consent
- Patients with first-ever acute ischemic or hemorrhagic stroke diagnosed by a neurologist or neurosurgeon within 4-12 weeks of onset,
- A baseline modified Rankin Scale score 2-4 on enrollment,
- A designated caregiver for each patient willing to assist the patient to be engaged in WEAR using the mobile embedded with APP.
Key exclusion criteria (2 listed)
- Planning to have further rehabilitation in other hospital and could be followed up in the participating hospital.
- The caregiver of patients not willing to assist patients to be engaged in WEAR.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Customized exercise appA Wearable Device-Based Assisted Post-Stroke Rehabilitation system | Device | Study Arm |
| In-person therapist-supervised rehabilitationIn-person therapist-supervised rehabilitation | Other | Control Arm, Study Arm |
Primary outcome
The primary outcome measure was changed in mRS, which was defined by scores of 0 to 4 on the modified Rankin scale
Time frame: Baseline, 30 days and 90 days
The primary outcome measure was changed in mRS, which was defined by scores of 0 to 4 on the modified Rankin scale, a global seven-level measure of functioning in which scores of 0 or 1 indicate a good outcome with no or minimal neurologic symptoms, scores of 2 to 5 indicate a poor outcome with increasing degree of disability, and 6 indicates death.
4 secondary outcomes
Change in Barthel Index (BI) at 30 days, 90 days
Time frame: Baseline, 30 days and 90 days
Change in upper limb (UL) function (Stream Wolf Motor Function Test)
Time frame: Baseline, 30 days and 90 days
Change in functional status (Functional Independence Measure)
Time frame: Baseline, 30 days and 90 days
Change in static and dynamic balance ability (Berg balance scale)
Time frame: Baseline, 30 days and 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Derived from this study: PubMed 39387211Ho HJ, Wu LC, Wu EH, Lee SF, Lee TH, Chiang SH, Chen CH, Chen HY, Pan SJ, Chen YW; WEAR-Stroke Study Group. Improving patient outcomes in acute and subacute stroke using a wearable device-assisted rehabilitation system: a randomized controlled trial. J Int Med Res. 2024 Oct;52(10):3000605241281425. doi: 10.1177/03000605241281425.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Customized exercise app and In-person therapist-supervised rehabilitation in people with Post-Acute-Stroke Rehabilitation, run by Landseed Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure was changed in mRS, which was defined by scores of 0 to 4 on the modified Rankin scale (time frame: Baseline, 30 days and 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04997408, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.