NCT02718534

Brief Summary

This study aimed to evaluate effectiveness of initial limb rehabilitation compare therapy took place within 48h with therapy took place after 48h for patients with stroke (modified Rankin Scale Score 3-4).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 24, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

January 5, 2021

Status Verified

January 1, 2021

Enrollment Period

1.4 years

First QC Date

March 15, 2016

Last Update Submit

January 3, 2021

Conditions

Time of First Rehabilitation Therapy

Outcome Measures

Primary Outcomes (1)

  • The primary outcome was a favourable outcome at 3 months after stroke, measured with the Fugl-Meyer motor function score.

    Fugl-Meyer score

    90 days

Secondary Outcomes (1)

  • The primary outcome was a favourable outcome at 3 months after stroke, measured with Modified Rankin Scale score.

    90 days

Study Arms (2)

ERTAS-1

EXPERIMENTAL

first limb rehabilitation therapy took place within 48h for patients with acute stroke (modified Rankin Scale Score 3-4)

Behavioral: stroke rehabilitation

ERTAS-2

ACTIVE COMPARATOR

first limb rehabilitation therapy took place after 48h for patients with acute stroke (modified Rankin Scale Score 3-4)

Behavioral: stroke rehabilitation

Interventions

stroke rehabilitationBEHAVIORAL

Physical rehabilitation exercise between 24 and 48 hours and after 48 hours

ERTAS-1ERTAS-2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients were diagnosed acute stroke within 24h onset. Head CT or MRI scans were confirmed the diagnosed.
  • The age was from 18 to 75 years old.
  • Temperature ≤38.0℃，Pulse rate 60-100bpm，Respiratory rate≤24 bpm，systolic blood pressure≤220mmHg.
  • Glasgow score: 9-14.
  • Acute Physiology and Chronic Health Evaluation(APACHE Ⅱ)score: ≤17.
  • National Institutes of Health Stroke Scale (NIHSS)score: \<16. (Upper and lower extremity motor function item score\<8).
  • Modified Rankin Scale score:3-4.
  • There were no serious diseases before, such as heart, liver, kidney and lung diseases.
  • Patients themselves or their nominated representative sign the informed consent form.

You may not qualify if:

  • There were unstable vital sign. There were serious organic dysfunction (heart, liver, kidney or lung).
  • Patients with transient ischemic attack.
  • Patients with subarachnoid haemorrhage.
  • Patients with haemorrhage were documented immediate surgery.
  • Pregnancy patients with stroke.
  • During the course of the project, major diseases took place (such as, myocardial infarction, gastrointestinal bleeding, respiratory failure, pulmonary embolism, deep vein thrombosis).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shengjing hospital of China Medical University

Shenyang, Liaoning, 110004, China

Location

Related Publications (2)

  • AVERT Trial Collaboration group. Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial. Lancet. 2015 Jul 4;386(9988):46-55. doi: 10.1016/S0140-6736(15)60690-0. Epub 2015 Apr 16.

    PMID: 25892679BACKGROUND

  • Wang F, Zhang S, Zhou F, Zhao M, Zhao H. Early physical rehabilitation therapy between 24 and 48 h following acute ischemic stroke onset: a randomized controlled trial. Disabil Rehabil. 2022 Jul;44(15):3967-3972. doi: 10.1080/09638288.2021.1897168. Epub 2021 Mar 18.

    PMID: 33736542DERIVED

MeSH Terms

Interventions

Stroke Rehabilitation

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Hongyu Zhao, doctor

    Shengjing Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
deputy director of emergency department

Study Record Dates

First Submitted

March 15, 2016

First Posted

March 24, 2016

Study Start

March 1, 2016

Primary Completion

August 1, 2017

Study Completion

November 1, 2019

Last Updated

January 5, 2021

Record last verified: 2021-01

Locations

CN(1)