Clinical trial NCT03938311: Time Window for Ischemic Stroke First Mobilization Effectiveness
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brain Ischemia
Stroke Rehabilitation
Keywords: Acute ischemic stroke
early rehabilitation
early mobilization
time window
multicenter randomized controlled trial
Lead sponsor: China Stroke Databank Center
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital with Nanjing Medical University
name: The Affiliated Hospital of Xuzhou Medical University
name: Nanjing Tongren Hospital
name: The First Affiliated Hospital of Soochow University
name: Nanjing Jiangbei People's Hospital
name: The First People's Hospital of Lianyungang
name: The First Affiliated Hospital of Zhengzhou University
name: Zibo Central Hospital
name: Liaocheng People's Hospital
name: Shandong Provincial Hospital
name: Xingtai People's Hospital
name: The First Hospital of Hebei Medical University
name: Cangzhou Central Hospital
name: Anhui Provincial Hospital
name: The First Affiliated Hospital of Bengbu Medical University
name: Jingmen No.1 People's Hospital
name: Wuhan University
name: Hainan General Hospital
name: The First Affiliated Hospital of Shanxi Medical University
name: Shanghai Pudong Hospital
name: Tianjin Medical University General Hospital
name: Chongqing Three Gorges Central Hospital
name: First Affiliated Hospital of Fujian Medical University
name: First People's Hospital of Yulin
name: First Affiliated Hospital of Xinjiang Medical University
First posted: 2019-05-06
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: modified Rankin Scale
timeFrame: 3 months after the cerebrovascular accident/or the last time appeared normally
Secondary outcomes:
measure: Barthel Index
timeFrame: the total score of Barthel Index will be recorded 15days、1month、3 months、6months after the cerebrovascular accident/or the last time appeared normally
measure: modified Rankin Scale
timeFrame: the total score of mRS will be recorded 15days、1month、6months after the cerebrovascular accident/or the last time appeared normally
measure: MMSE
timeFrame: the total score of MMSE will be recorded 15days、1month、3 months、6months after the cerebrovascular accident/or the last time appeared normally
measure: NIHSS scores
timeFrame: the total score of NIHSS will be recorded15days、1month、6months after the cerebrovascular accident/or the last time appeared normally
measure: Incidence of important medical events
timeFrame: The incidence of important medical events will be recorded 15days、1month、3 months after the cerebrovascular accident/or the last time appeared normally
measure: Hospital LOS
timeFrame: Hospital LOS will be recorded 3 months after the cerebrovascular accident/or the last time appeared normally
measure: Total medical cost
timeFrame: medical cost will be recorded 3 months after the cerebrovascular accident/or the last time appeared normally
Other outcomes:
measure: CBF
timeFrame: the count of CBF will be recorded 3months after the cerebrovascular accident/or the last time appeared normally
measure: CBV
timeFrame: the count of CBV will be recorded 3months after the cerebrovascular accident/or the last time appeared normally
measure: FA
timeFrame: 3months after the cerebrovascular accident/or the last time appeared normally
measure: MD
timeFrame: 3months after the cerebrovascular accident/or the last time appeared normally
measure: rsFC
timeFrame: the rsFC description will be recorded by a radiologist 3months after the cerebrovascular accident/or the last time appeared normally
Locations:
city: Nanjing
country: China
facility: the First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Lu Xiao, MD/PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.