Time Window for Ischemic Stroke First Mobilization Effectiveness

Brain Ischemia Clinical Trial

— TIME  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03938311
• Other study ID #: GN-2018R0010
• Status: Recruiting
• Phase: N/A
• Start date: August 13, 2019
• Est. completion date: December 2022

Study information

• Verified date: March 2022
• Source: China Stroke Databank Center
• Contact: Lu Xiao, MD/PHD
• Phone: +86 025-83718836
• Email: luxiao1972[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Ischemia
• Ischemia
• Ischemic Stroke
• Stroke
• Stroke Rehabilitation

Intervention

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.

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)	Nanjing	Jiangsu

Sponsors (26)

Lead Sponsor

Collaborator

China Stroke Databank Center

Anhui Provincial Hospital, Cangzhou Central Hospital, Chongqing Three Gorges Central Hospital, First Affiliated Hospital Bengbu Medical College, First Affiliated Hospital of Fujian Medical University, First Affiliated Hospital of Xinjiang Medical University, First People's Hospital of Yulin, Hainan General Hospital, Jingmen No.1 People's Hospital, Liaocheng People's Hospital, Nanjing Jiangbei People's Hospital, Nanjing Tongren Hospital, Shandong Provincial Hospital, Shanghai Pudong Hospital, The Affiliated Hospital of Xuzhou Medical University, The First Affiliated Hospital of Shanxi Medical University, The First Affiliated Hospital of Soochow University, The First Affiliated Hospital of Zhengzhou University, The First Affiliated Hospital with Nanjing Medical University, The First Hospital of Hebei Medical University, The First People's Hospital of Lianyungang, Tianjin Medical University General Hospital, Wuhan University, Xingtai People's Hospital, Zibo Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	CBF	cerebral blood flow	the count of CBF will be recorded 3months after the cerebrovascular accident/or the last time appeared normally
Other	CBV	cerebral blood volume	the count of CBV will be recorded 3months after the cerebrovascular accident/or the last time appeared normally
Other	FA	fractional anisotropy, a outcome of diffusion tensor imaging	3months after the cerebrovascular accident/or the last time appeared normally
Other	MD	mean diffusivity,a outcome of diffusion tensor imaging	3months after the cerebrovascular accident/or the last time appeared normally
Other	rsFC	resting-state functional connectivity	the rsFC description will be recorded by a radiologist 3months after the cerebrovascular accident/or the last time appeared normally
Primary	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.	3 months after the cerebrovascular accident/or the last time appeared normally
Secondary	Barthel Index	ability of daily living, total scores range from 0 to 100, higher values represent a better outcome and independent living ability.	the total score of Barthel Index will be recorded 15days?1month?3 months?6months after the cerebrovascular accident/or the last time appeared normally
Secondary	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.	the total score of mRS will be recorded 15days?1month?6months after the cerebrovascular accident/or the last time appeared normally
Secondary	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.	the total score of MMSE will be recorded 15days?1month?3 months?6months after the cerebrovascular accident/or the last time appeared normally
Secondary	NIHSS scores	National Institute of Health stroke scale,total scores range from 0 to 42, higher values represent a better outcome.	the total score of NIHSS will be recorded15days?1month?6months after the cerebrovascular accident/or the last time appeared normally
Secondary	Incidence of important medical events	falls, trauma, fracture, syncope, epilepsy, pneumonia, atelectasis, venous thrombosis, pulmonary embolism, pressure sores, death, etc.	The incidence of important medical events will be recorded 15days?1month?3 months after the cerebrovascular accident/or the last time appeared normally
Secondary	Hospital LOS	length of stay in the acute hospital and in the rehabilitation hospital, and total hospital length of stay	Hospital LOS will be recorded 3 months after the cerebrovascular accident/or the last time appeared normally
Secondary	Total medical cost	addition of the cost of each admission of the acute hospital and the rehabilitation hospital	medical cost will be recorded 3 months after the cerebrovascular accident/or the last time appeared normally