Brain IschemiaTIMENCT03938311
Time Window for Ischemic Stroke First Mobilization Effectiveness
A study testing early rehabilitation in people with Brain Ischemia and Stroke Rehabilitation, run by China Stroke Databank Center at 1 site in China.
Trial summary
Early mobilization was thought to be effective in patients with acute ischemic stroke. As the essential component of stroke unit care, early mobilization has already been part of routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Ischemia, Stroke Rehabilitation
- What is being tested?
- early rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 13 Aug 2019to Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1 diagnosed with ischemic stroke through anamnesis, clinical symptoms, and radiographic assessment;
- 2 aged 18 years or older;
- 3 of ischemic stroke within 12 hours before eligibility check;
- 4 able to verbally respond to the instructions;
- 5 with stable vital signs (systolic blood pressure 120-180 mmHg, heart rate 50-100/min, body temperature <37.5◦C, blood oxygen saturation >92%)
- 6MMSE score > 16;
- 7participation in the TIME Trial and sign the consent form.
Who cannot join
- 1 diagnosed with hemorrhagic stroke;
- 2 NIHSS score < 2;
- 3 pre-morbid modified Ranking Scale (mRS) score of 3-5;
- 4 refusing randomization;
- 5 having severe limb dysfunction or systemic diseases rendering them unable to cooperate in the mobilization intervention;
- 6 having severe cognitive and mental dysfunctions;
- 7 currently enrolled in another trial or having participated in a clinical trial within 6 months before stroke onset.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
Nanjing, Jiangsu, 210029
Yan Chengjie, postgraduate, +8615995610375, jiabailie00@sina.com
Zhang Xintong, Xintong, +8615720802936
About this study
Official title: Time Window for Early Mobilization in Improving Prognostic Outcomes in Patients With Acute Ischemic Stroke: an Investigator-Initiated Prospective Multicenter Randomized 3-Arm Clinical Trial
Early mobilization was thought to be effective in patients with acute ischemic stroke. As the essential component of stroke unit care, early mobilization has already been part of routine clinical practice. However, it is uncertain that which and when medical service focusing on functional recovery should be delivered after the emergency interventions for stroke. Besides, the optimal time window, for delivering early mobilization after acute ischemic stroke, has not been verified with strong evidence.
Read the detailed description
The TIME Trial is a pragmatic, investigator-initiated, multi-center, randomized, 3-arm parallel group, clinical trial. This trial will be conducted in 57 general hospitals in mainland China affiliated with the China Stroke Databank Center and will enroll 6033 eligible patients with acute ischemic stroke. Participants will be randomly allocated to either (1) the very early mobilization group in whichmobilization is initiated within 24 hours from stroke onset, (2) the early mobilization group in which mobilization begins between 24 and 72 hours poststroke, or (3) the late mobilization group in which mobilization is started after 72 hours poststroke. The mobilization protocol is otherwise standardized and identical for each comparison group. Mobilization is titrated by baseline mobility level and progress of patients throughout the intervention period. The primary outcome is death or disability assessed with the modified Rankin scale at 3 months poststroke. Secondary outcomes include impairment score of the National Institutes of Health Stroke Scale, dependence in activities of daily living as measured using the modified Barthel Index, cognitive ability assessed with the Mini-Mental State Examination, incidence of adverse events, hospital length of stay, and total medical costs.
Study design: an Investigator-Initiated Prospective Multicenter Randomized 3-Arm Clinical Trial
Sample size: 1500 cases
- Conditions
- Brain Ischemia, Stroke Rehabilitation
- Being tested
- early rehabilitation
- Keywords
- Acute ischemic stroke, early rehabilitation, early mobilization, time window, multicenter randomized controlled trial
- Medical subject headings
- Brain Ischemia, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early rehabilitationOther
The three study groups share a same intervention protocol in addition to the initiation timing of intervention from the stroke onset. The frequency and intensity of the intervention is titrated according to functional activity baseline and monitored daily and adjusted with recovery. Encourage patients to move out of bed as soon as possible.
Definition of bed movement: Encourage and help patients to perform functional actions, focusing on activities such as sitting, standing, walking out of the bed.
| Study group | Role | What they receive |
|---|---|---|
| very early rehabilitation | Experimental | early mobilization initiates within 24h from the onset of the disease Receives: Other: early rehabilitation |
| relative early rehabilitation | Experimental | early mobilization initiates between 24-72h from the onset of the disease Receives: Other: early rehabilitation |
| late mobilization group | Experimental | early mobilization initiates after 72h from the onset of the disease Receives: Other: early rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin Scale
modified Rankin Scale, to evaluate a subject's disability status. It's a rating data. The degrees range from 0 to 6, higher values represent a worse outcome and severe disability.
Measured: 3 months after the cerebrovascular accident/or the last time appeared normally
Secondary outcomes (7)
Barthel Index
ability of daily living, total scores range from 0 to 100, higher values represent a better outcome and independent living ability.
Measured: the total score of Barthel Index will be recorded 15days、1month、3 months、6months after the cerebrovascular accident/or the last time appeared normally
modified Rankin Scale
modified Rankin Scale, to evaluate a subject's disability status. It's a rating data. The degrees range from 0 to 6, higher values represent a worse outcome and severe disability.
Measured: the total score of mRS will be recorded 15days、1month、6months after the cerebrovascular accident/or the last time appeared normally
MMSE
Mini-mental State Examination. To evaluate a subject's mental state.The total score range from 0 to 30, higher values represent a better outcome.
Measured: the total score of MMSE will be recorded 15days、1month、3 months、6months after the cerebrovascular accident/or the last time appeared normally
NIHSS scores
National Institute of Health stroke scale，total scores range from 0 to 42, higher values represent a better outcome.
Measured: the total score of NIHSS will be recorded15days、1month、6months after the cerebrovascular accident/or the last time appeared normally
Incidence of important medical events
falls, trauma, fracture, syncope, epilepsy, pneumonia, atelectasis, venous thrombosis, pulmonary embolism, pressure sores, death, etc.
Measured: The incidence of important medical events will be recorded 15days、1month、3 months after the cerebrovascular accident/or the last time appeared normally
Hospital LOS
length of stay in the acute hospital and in the rehabilitation hospital, and total hospital length of stay
Measured: Hospital LOS will be recorded 3 months after the cerebrovascular accident/or the last time appeared normally
Total medical cost
addition of the cost of each admission of the acute hospital and the rehabilitation hospital
Measured: medical cost will be recorded 3 months after the cerebrovascular accident/or the last time appeared normally
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start13 Aug 2019
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (estimated)
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 Brain IschemiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with acute ischemic stroke fulfilling the inclusion and exclusion criteria will be randomly allocated to either either (1) the very early mobilization group in whichmobilization is initiated within 24 hours from stroke onset, (2) the early mobilization group in which mobilization begins between 24 and 72 hours poststroke, or (3) the late mobilization group in which mobilization is started after 72 hours poststroke.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Stroke Databank Center
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University, The Affiliated Hospital of Xuzhou Medical University, Nanjing Tongren Hospital, The First Affiliated Hospital of Soochow University, Nanjing Jiangbei People's Hospital, The First People's Hospital of Lianyungang, The First Affiliated Hospital of Zhengzhou University, Zibo Central Hospital, Liaocheng People's Hospital, Shandong Provincial Hospital, Xingtai People's Hospital, The First Hospital of Hebei Medical University, Cangzhou Central Hospital, Anhui Provincial Hospital, The First Affiliated Hospital of Bengbu Medical University, Jingmen No.1 People's Hospital, Wuhan University, Hainan General Hospital, The First Affiliated Hospital of Shanxi Medical University, Shanghai Pudong Hospital, Tianjin Medical University General Hospital, Chongqing Three Gorges Central Hospital, First Affiliated Hospital of Fujian Medical University, First People's Hospital of Yulin, First Affiliated Hospital of Xinjiang Medical University
- Responsible party
- Principal investigator, Xiao Lu,MD, China Stroke Databank Center
- Investigators
- Lu Xiao, MD/PHD, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03938311
- Sponsor's protocol ID
- GN-2018R0010
- Acronym
- TIME
- Status last verified
- Mar 2022
- First submitted
- 27 Apr 2019
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zheng Y, Yan C, Shi H, Niu Q, Liu Q, Lu S, Zhang X, Cheng Y, Teng M, Wang L, Zhang X, Hu X, Li J, Lu X, Reinhardt JD; TIME Trial Collaboration Group. Time Window for Ischemic Stroke First Mobilization Effectiveness: Protocol for an Investigator-Initiated Prospective Multicenter Randomized 3-Arm Clinical Trial. Phys Ther. 2021 May 4;101(5):pzab038. doi: 10.1093/ptj/pzab038.
PubMed 33513232
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Window for Early Mobilization in Improving Prognostic Outcomes in Patients With Acute Ischemic Stroke: an Investigator-Initiated Prospective Multicenter Randomized 3-Arm Clinical Trial
- ClinicalTrials.gov ID
- NCT03938311
- Acronym / sponsor ID
- TIME / GN-2018R0010
- Conditions
- Brain Ischemia, Stroke Rehabilitation
- Keywords
- Acute ischemic stroke, early rehabilitation, early mobilization, time window, multicenter randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- China Stroke Databank CenterUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University, The Affiliated Hospital of Xuzhou Medical University, Nanjing Tongren Hospital, The First Affiliated Hospital of Soochow University, Nanjing Jiangbei People's Hospital, The First People's Hospital of Lianyungang, The First Affiliated Hospital of Zhengzhou University, Zibo Central Hospital, Liaocheng People's Hospital, Shandong Provincial Hospital, Xingtai People's Hospital, The First Hospital of Hebei Medical University, Cangzhou Central Hospital, Anhui Provincial Hospital, The First Affiliated Hospital of Bengbu Medical University, Jingmen No.1 People's Hospital, Wuhan University, Hainan General Hospital, The First Affiliated Hospital of Shanxi Medical University, Shanghai Pudong Hospital, Tianjin Medical University General Hospital, Chongqing Three Gorges Central Hospital, First Affiliated Hospital of Fujian Medical University, First People's Hospital of Yulin, First Affiliated Hospital of Xinjiang Medical University
- Study start
- 13 Aug 2019 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 6 May 2019 (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.
Early mobilization was thought to be effective in patients with acute ischemic stroke. As the essential component of stroke unit care, early mobilization has already been part of routine clinical practice. However, it is uncertain that which and when medical service focusing on functional recovery should be delivered after the emergency interventions for stroke. Besides, the optimal time window, for delivering early mobilization after acute ischemic stroke, has not been verified with strong evidence.
Detailed description
The TIME Trial is a pragmatic, investigator-initiated, multi-center, randomized, 3-arm parallel group, clinical trial. This trial will be conducted in 57 general hospitals in mainland China affiliated with the China Stroke Databank Center and will enroll 6033 eligible patients with acute ischemic stroke. Participants will be randomly allocated to either (1) the very early mobilization group in whichmobilization is initiated within 24 hours from stroke onset, (2) the early mobilization group in which mobilization begins between 24 and 72 hours poststroke, or (3) the late mobilization group in which mobilization is started after 72 hours poststroke. The mobilization protocol is otherwise standardized and identical for each comparison group. Mobilization is titrated by baseline mobility level and progress of patients throughout the intervention period. The primary outcome is death or disability assessed with the modified Rankin scale at 3 months poststroke. Secondary outcomes include impairment score of the National Institutes of Health Stroke Scale, dependence in activities of daily living as measured using the modified Barthel Index, cognitive ability assessed with the Mini-Mental State Examination, incidence of adverse events, hospital length of stay, and total medical costs.
Study design: an Investigator-Initiated Prospective Multicenter Randomized 3-Arm Clinical Trial
Sample size: 1500 cases
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Patients with acute ischemic stroke fulfilling the inclusion and exclusion criteria will be randomly allocated to either either (1) the very early mobilization group in whichmobilization is initiated within 24 hours from stroke onset, (2) the early mobilization group in which mobilization begins between 24 and 72 hours poststroke, or (3) the late mobilization group in which mobilization is started after 72 hours poststroke.
| Arm | Type | Receives |
|---|---|---|
| very early rehabilitation | Experimental | Other: early rehabilitationearly mobilization initiates within 24h from the onset of the disease |
| relative early rehabilitation | Experimental | Other: early rehabilitationearly mobilization initiates between 24-72h from the onset of the disease |
| late mobilization group | Experimental | Other: early rehabilitationearly mobilization initiates after 72h from the onset of the disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1 diagnosed with ischemic stroke through anamnesis, clinical symptoms, and radiographic assessment;
- 2 aged 18 years or older;
- 3 of ischemic stroke within 12 hours before eligibility check;
- 4 able to verbally respond to the instructions;
- 5 with stable vital signs (systolic blood pressure 120-180 mmHg, heart rate 50-100/min, body temperature <37.5◦C, blood oxygen saturation >92%)
Key exclusion criteria (7 listed)
- 1 diagnosed with hemorrhagic stroke;
- 2 NIHSS score < 2;
- 3 pre-morbid modified Ranking Scale (mRS) score of 3-5;
- 4 refusing randomization;
- 5 having severe limb dysfunction or systemic diseases rendering them unable to cooperate in the mobilization intervention;
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 |
|---|---|---|
| early rehabilitationThe three study groups share a same intervention protocol in addition to the initiation timing of intervention from the stroke onset. The frequency and intensity of the intervention is titrated according to functional activity baseline and monitored daily and adjusted with recovery. Encourage patients to move out of bed as soon as possible. Definition of bed movement: Encourage and help patients to perform functional actions, focusing on activities such as sitting, standing, walking out of the bed. | Other | late mobilization group, relative early rehabilitation, very early rehabilitation |
Primary outcome
modified Rankin Scale
Time frame: 3 months after the cerebrovascular accident/or the last time appeared normally
modified Rankin Scale, to evaluate a subject's disability status. It's a rating data. The degrees range from 0 to 6, higher values represent a worse outcome and severe disability.
7 secondary outcomes
Barthel Index
Time frame: the total score of Barthel Index will be recorded 15days、1month、3 months、6months after the cerebrovascular accident/or the last time appeared normally
modified Rankin Scale
Time frame: the total score of mRS will be recorded 15days、1month、6months after the cerebrovascular accident/or the last time appeared normally
MMSE
Time frame: the total score of MMSE will be recorded 15days、1month、3 months、6months after the cerebrovascular accident/or the last time appeared normally
NIHSS scores
Time frame: the total score of NIHSS will be recorded15days、1month、6months after the cerebrovascular accident/or the last time appeared normally
Incidence of important medical events
Time frame: The incidence of important medical events will be recorded 15days、1month、3 months after the cerebrovascular accident/or the last time appeared normally
Hospital LOS
Time frame: Hospital LOS will be recorded 3 months after the cerebrovascular accident/or the last time appeared normally
Total medical cost
Time frame: medical cost will be recorded 3 months after the cerebrovascular accident/or the last time appeared normally
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 33513232Zheng Y, Yan C, Shi H, Niu Q, Liu Q, Lu S, Zhang X, Cheng Y, Teng M, Wang L, Zhang X, Hu X, Li J, Lu X, Reinhardt JD; TIME Trial Collaboration Group. Time Window for Ischemic Stroke First Mobilization Effectiveness: Protocol for an Investigator-Initiated Prospective Multicenter Randomized 3-Arm Clinical Trial. Phys Ther. 2021 May 4;101(5):pzab038. doi: 10.1093/ptj/pzab038.
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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.
Lu Xiao, MD/PHD principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing early rehabilitation in people with Brain Ischemia and Stroke Rehabilitation, run by China Stroke Databank Center at 1 site in China.
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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lu Xiao, MD/PHD (+86 025-83718836 ext. 3029, luxiao1972@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin Scale (time frame: 3 months after the cerebrovascular accident/or the last time appeared normally). 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 NCT03938311, 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 31 Mar 2022.