NCT03938311

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 6, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

August 13, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

3.1 years

First QC Date

April 27, 2019

Last Update Submit

March 26, 2022

Conditions

Brain IschemiaStroke Rehabilitation

Keywords

Acute ischemic strokeearly rehabilitationearly mobilizationtime windowmulticenter randomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Barthel Index

    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

    the total score of mRS will be recorded 15days、1month、6months after the cerebrovascular accident/or the last time appeared normally

  • MMSE

    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

    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

    The incidence of important medical events will be recorded 15days、1month、3 months after the cerebrovascular accident/or the last time appeared normally

  • +2 more secondary outcomes

Other Outcomes (5)

  • CBF

    the count of CBF will be recorded 3months after the cerebrovascular accident/or the last time appeared normally

  • CBV

    the count of CBV will be recorded 3months after the cerebrovascular accident/or the last time appeared normally

  • FA

    3months after the cerebrovascular accident/or the last time appeared normally

  • +2 more other outcomes

Study Arms (3)

very early rehabilitation

EXPERIMENTAL

early mobilization initiates within 24h from the onset of the disease

Other: early rehabilitation

relative early rehabilitation

EXPERIMENTAL

early mobilization initiates between 24-72h from the onset of the disease

Other: early rehabilitation

late mobilization group

EXPERIMENTAL

early mobilization initiates after 72h from the onset of the disease

Other: early rehabilitation

Interventions

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.

late mobilization grouprelative early rehabilitationvery early rehabilitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed with ischemic stroke through anamnesis, clinical symptoms, and radiographic assessment;
  • aged 18 years or older;
  • of ischemic stroke within 12 hours before eligibility check;
  • able to verbally respond to the instructions;
  • with stable vital signs (systolic blood pressure 120-180 mmHg, heart rate 50-100/min, body temperature \<37.5◦C, blood oxygen saturation \>92%)
  • MMSE score \> 16;
  • participation in the TIME Trial and sign the consent form.

You may not qualify if:

  • diagnosed with hemorrhagic stroke;
  • NIHSS score \< 2;
  • pre-morbid modified Ranking Scale (mRS) score of 3-5;
  • refusing randomization;
  • having severe limb dysfunction or systemic diseases rendering them unable to cooperate in the mobilization intervention;
  • having severe cognitive and mental dysfunctions;
  • currently enrolled in another trial or having participated in a clinical trial within 6 months before stroke onset.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)

Nanjing, Jiangsu, 210029, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33513232DERIVED

MeSH Terms

Conditions

Brain IschemiaIschemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesStroke

Study Officials

  • Lu Xiao, MD/PHD

    The First Affiliated Hospital with Nanjing Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lu Xiao, MD/PHD

CONTACT

+86 025-83718836luxiao1972@163.com

Yan Chengjie, postgraduate

CONTACT

+8615995610375jiabailie00@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

April 27, 2019

First Posted

May 6, 2019

Study Start

August 13, 2019

Primary Completion

October 1, 2022

Study Completion

December 1, 2022

Last Updated

March 31, 2022

Record last verified: 2022-03

Locations

CN(1)