Study on the Effectiveness and Safety of Early Rehabilitation After Ischemic Stroke

Overview

There are about 2.5 million new stroke patients in China each year, and 70%-80% of stroke patients cannot live independently because of their disability. Stroke has the characteristics of high morbidity and high morbidity, which is a huge burden for families and society.The effectiveness of early rehabilitation has been confirmed, but there is a lot of debate about the best intervention time for early rehabilitation. Our study is to observe the effectiveness and safety of early rehabilitation after ischemic stroke, and to lay the foundation for establishing early rehabilitation guidelines for ischemic stroke in Chinese population.

Full Title of Study: “A Study on the Effectiveness and Safety of Early Rehabilitation After a Ischemic Stroke”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: February 2022

Detailed Description

Objective: To observe the effectiveness and safety of early rehabilitation after ischemic stroke, and to lay the foundation for establishing early rehabilitation guidelines for ischemic stroke in Chinese population; to explore the internal rehabilitation of early ischemic stroke and brain remodeling.

Study design: a multicenter, evaluator blinded, randomized controlled clinical study

Sample size: 1500 cases

Inclusion criterias: 1 age > 18 years; 2 first or recurrent ischemic stroke, conform to the diagnostic criteria of ischemic stroke, and confirmed by CT or MRI; 3 symptoms occur within 24 hours; 4 can be oral instructions Respond; 5 vital signs are stable (systolic blood pressure is between 120-180mmHg, heart rate is between 50-100 /min, body temperature is lower than 38.5 °C, blood oxygen saturation is >92%); 6MMSE>16 points.

Exclusion criterias: 1 patients with a hemorrhagic stroke; 2 patients with a NIHSS score of less than 2; 3 patients with continuous progressing disease within the first hour after admission, presence of progressive neurological damage, acute coronary syndrome, severe heart failure, confirmed or suspected lower extremity fracture; 4 Modified Rankin scale (mRS) score of 3, 4, 5 points before stroke; 5 can not provide informed consent.

Treatment plan According to the severity of the patient's condition, the NIHSS score of 15 is divided into two levels, 2-15 points and 16-42 points. Follow-up randomization within the group: rehabilitation treatment within 24 hours after stroke (group A), rehabilitation treatment within 24 to 72 hours after stroke (group B), rehabilitation treatment started more than 72 hours after stroke (group C). According to the function evaluation of each patient, the corresponding rehabilitation treatment was arranged.

Efficacy evaluation: NIHSS score, Barthel index, modified Rankin scale, MMSE scale, imaging assessment (arterial spin labeling, diffusion tensor imaging, resting state functional MRI imaging), health economic indicators, etc.

Statistical analysis: Statistical analysis was performed with SPSS 23.0. One-way analysis of variance was used to compare statistical differences between the groups (5 time points) and between groups (3 intervention groups); the correlation between brain function imaging and clinical efficacy was explored by correlation analysis; Multivariate analysis methods such as discriminant and cluster analysis were used to explore the clinical and brain function imaging predictive indicators and thresholds that can reflect the prognosis of stroke function. Multiple regression analysis was used to analyze the factors affecting the prognosis of patients.

Interventions

  • Other: rehabilitation
    • Rehabilitation treatment is arranged based on each patient’s functional assessment. 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.

Arms, Groups and Cohorts

  • Experimental: very early rehabilitation
    • rehabilitation treatment within 24 hours after stroke
  • Experimental: early rehabilitation
    • rehabilitation treatment within 24 to 72 hours after stroke
  • Experimental: delayed rehabilitation
    • rehabilitation treatment started 72 hours after stroke

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • 1 age > 18 years;
  • 2 first or recurrent ischemic stroke, conform to the diagnostic criteria of ischemic stroke, and confirmed by CT or MRI;
  • 3 symptoms occur within 24 hours;
  • 4 can be oral instructions Respond;
  • 5 vital signs are stable (systolic blood pressure is between 120-180mmHg, heart rate is between 50-100 /min, body temperature is lower than 38.5 °C, blood oxygen saturation is >92%);
  • 6MMSE>16 points.

Exclusion Criteria

  • 1 patients with a hemorrhagic stroke;
  • 2 patients with a NIHSS score of less than 2;
  • 3 patients with continuous progressing disease within the first hour after admission, presence of progressive neurological damage, acute coronary syndrome, severe heart failure, confirmed or suspected lower extremity fracture;
  • 4 Modified Rankin scale (mRS) score of 3, 4, 5 points before stroke;
  • 5 can not provide informed consent.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • China Stroke Databank Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Xiao Lu, MD/PHD, Principal Investigator, The First Affiliated Hospital with Nanjing Medical University
  • Overall Contact(s)
    • Xiao Lu, MD/PHD, +86 025-83718836, luxiao1972@163.com

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