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出境医 / 临床实验 / Time Window for Ischemic Stroke First Mobilization Effectiveness (TIME)

Time Window for Ischemic Stroke First Mobilization Effectiveness (TIME)

Study Description
Brief 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. 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.

Condition or disease Intervention/treatment Phase
Brain Ischemia Stroke Rehabilitation Other: early rehabilitation Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Masking Description: Pre-admission trial assistants and medical staff aware of group allocation will not have contact with the patients. At each study site, a group of physiotherapists will be responsible for the interventions for all three study groups. Multi-disciplinary physicians, assessors, data analysts, and statisticians will be blinded to the group allocation.
Primary Purpose: Treatment
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
Actual Study Start Date : August 13, 2019
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : May 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: very early rehabilitation
early mobilization initiates within 24h from the onset of the disease
 Other: early rehabilitation

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.
Experimental: relative early rehabilitation
early mobilization initiates between 24-72h from the onset of the disease
 Other: early rehabilitation

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.
Experimental: late mobilization group
early mobilization initiates after 72h from the onset of the disease
 Other: early rehabilitation

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.
Outcome Measures
Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    ability of daily living, total scores range from 0 to 100, higher values represent a better outcome and independent living ability.

  2. 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 ]
    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.

  3. 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 ]
    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.

  4. NIHSS scores [ Time Frame: the total score of NIHSS will be recorded15days、1month、6months after the cerebrovascular accident/or the last time appeared normally ]
    National Institute of Health stroke scale，total scores range from 0 to 42, higher values represent a better outcome.

  5. 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 ]
    falls, trauma, fracture, syncope, epilepsy, pneumonia, atelectasis, venous thrombosis, pulmonary embolism, pressure sores, death, etc.

  6. Hospital LOS [ Time Frame: Hospital LOS will be recorded 3 months after the cerebrovascular accident/or the last time appeared normally ]
    length of stay in the acute hospital and in the rehabilitation hospital, and total hospital length of stay

  7. Total medical cost [ Time Frame: medical cost will be recorded 3 months after the cerebrovascular accident/or the last time appeared normally ]
    addition of the cost of each admission of the acute hospital and the rehabilitation hospital


Other Outcome Measures:
  1. CBF [ Time Frame: the count of CBF will be recorded 3months after the cerebrovascular accident/or the last time appeared normally ]
    cerebral blood flow

  2. CBV [ Time Frame: the count of CBV will be recorded 3months after the cerebrovascular accident/or the last time appeared normally ]
    cerebral blood volume

  3. FA [ Time Frame: 3months after the cerebrovascular accident/or the last time appeared normally ]
    fractional anisotropy, a outcome of diffusion tensor imaging

  4. MD [ Time Frame: 3months after the cerebrovascular accident/or the last time appeared normally ]
    mean diffusivity,a outcome of diffusion tensor imaging

  5. rsFC [ Time Frame: the rsFC description will be recorded by a radiologist 3months after the cerebrovascular accident/or the last time appeared normally ]
    resting-state functional connectivity


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Lu Xiao, MD/PHD +86 025-83718836 ext 3029 luxiao1972@163.com
Contact: Yan Chengjie, postgraduate +8615995610375 jiabailie00@sina.com

Locations
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China, Jiangsu
the First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital) Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Yan Chengjie, postgraduate    +8615995610375    jiabailie00@sina.com   
Contact: Zhang Xintong, Xintong    +8615720802936      
Sub-Investigator: Yan Chengjie, postgraduate         
Sponsors and Collaborators
China Stroke Databank Center
The First Affiliated Hospital with Nanjing Medical University
Investigators
Layout table for investigator information
Principal Investigator: Lu Xiao, MD/PHD The First Affiliated Hospital with Nanjing Medical University
Tracking Information
First Submitted Date  ICMJE April 27, 2019
First Posted Date  ICMJE May 6, 2019
Last Update Posted Date March 11, 2021
Actual Study Start Date  ICMJE August 13, 2019
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2021) 		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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 2, 2019) 		NIHSS scores [ Time Frame: the total score of NIHSS will be recorded 3 months after the cerebrovascular accident/or the last time appeared normally ]
National Institute of Health stroke scale，total scores range from 0 to 42, higher values represent a better outcome.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2021)
  • 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 ]
    ability of daily living, total scores range from 0 to 100, higher values represent a better outcome and independent living ability.
  • 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 ]
    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.
  • 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 ]
    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.
  • NIHSS scores [ Time Frame: the total score of NIHSS will be recorded15days、1month、6months after the cerebrovascular accident/or the last time appeared normally ]
    National Institute of Health stroke scale，total scores range from 0 to 42, higher values represent a better outcome.
  • 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 ]
    falls, trauma, fracture, syncope, epilepsy, pneumonia, atelectasis, venous thrombosis, pulmonary embolism, pressure sores, death, etc.
  • Hospital LOS [ Time Frame: Hospital LOS will be recorded 3 months after the cerebrovascular accident/or the last time appeared normally ]
    length of stay in the acute hospital and in the rehabilitation hospital, and total hospital length of stay
  • Total medical cost [ Time Frame: medical cost will be recorded 3 months after the cerebrovascular accident/or the last time appeared normally ]
    addition of the cost of each admission of the acute hospital and the rehabilitation hospital
Original Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2019)
  • 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 ]
    ability of daily living, total scores range from 0 to 100, higher values represent a better outcome and independent living ability.
  • modified Rankin Scale [ Time Frame: the degree of modified Rankin Scale will be recorded 15days、1month、3 months、6months 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 5, higher values represent a worse outcome and severe disability.
  • 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 ]
    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.
  • NIHSS scores [ Time Frame: the total score of NIHSS will be recorded15days、1month、6months after the cerebrovascular accident/or the last time appeared normally ]
    National Institute of Health stroke scale，total scores range from 0 to 42, higher values represent a better outcome.
Current Other Pre-specified Outcome Measures
 (submitted: January 12, 2020)
  • CBF [ Time Frame: the count of CBF will be recorded 3months after the cerebrovascular accident/or the last time appeared normally ]
    cerebral blood flow
  • CBV [ Time Frame: the count of CBV will be recorded 3months after the cerebrovascular accident/or the last time appeared normally ]
    cerebral blood volume
  • FA [ Time Frame: 3months after the cerebrovascular accident/or the last time appeared normally ]
    fractional anisotropy, a outcome of diffusion tensor imaging
  • MD [ Time Frame: 3months after the cerebrovascular accident/or the last time appeared normally ]
    mean diffusivity,a outcome of diffusion tensor imaging
  • rsFC [ Time Frame: the rsFC description will be recorded by a radiologist 3months after the cerebrovascular accident/or the last time appeared normally ]
    resting-state functional connectivity
Original Other Pre-specified Outcome Measures
 (submitted: May 2, 2019)
  • CBF [ Time Frame: the count of CBF will be recorded 3months after the cerebrovascular accident/or the last time appeared normally ]
    cerebral blood flow
  • CBV [ Time Frame: the count of CBV will be recorded 3months after the cerebrovascular accident/or the last time appeared normally ]
    cerebral blood volume
  • FA [ Time Frame: 3months after the cerebrovascular accident/or the last time appeared normally ]
    fractional anisotropy, a outcome of diffusion tensor imging
  • MD [ Time Frame: 3months after the cerebrovascular accident/or the last time appeared normally ]
    mean diffusivity,a outcome of diffusion tensor imging
  • rsFC [ Time Frame: the rsFC description will be recorded by a radiologist 3months after the cerebrovascular accident/or the last time appeared normally ]
    resting-statefunctional connectivity
 
Descriptive Information
Brief Title  ICMJE Time Window for Ischemic Stroke First Mobilization Effectiveness
Official Title  ICMJE 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
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Masking Description:
Pre-admission trial assistants and medical staff aware of group allocation will not have contact with the patients. At each study site, a group of physiotherapists will be responsible for the interventions for all three study groups. Multi-disciplinary physicians, assessors, data analysts, and statisticians will be blinded to the group allocation.
Primary Purpose: Treatment
Condition  ICMJE
  • Brain Ischemia
  • Stroke Rehabilitation
Intervention  ICMJE Other: early rehabilitation

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 Arms  ICMJE
  • Experimental: very early rehabilitation
    early mobilization initiates within 24h from the onset of the disease
    Intervention: Other: early rehabilitation
  • Experimental: relative early rehabilitation
    early mobilization initiates between 24-72h from the onset of the disease
    Intervention: Other: early rehabilitation
  • Experimental: late mobilization group
    early mobilization initiates after 72h from the onset of the disease
    Intervention: Other: early rehabilitation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 2, 2019) 		1500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lu Xiao, MD/PHD +86 025-83718836 ext 3029 luxiao1972@163.com
Contact: Yan Chengjie, postgraduate +8615995610375 jiabailie00@sina.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03938311
Other Study ID Numbers  ICMJE GN-2018R0010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party China Stroke Databank Center
Study Sponsor  ICMJE China Stroke Databank Center
Collaborators  ICMJE The First Affiliated Hospital with Nanjing Medical University
Investigators  ICMJE
Principal Investigator: Lu Xiao, MD/PHD The First Affiliated Hospital with Nanjing Medical University
PRS Account China Stroke Databank Center
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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