The Effect and Mechanism of wCST-LL Based Precision Rehabilitation Nursing on Motor Dysfunction After Acute Stroke

February 11, 2020 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
Ischemic stroke is the main cause of disability in the world. More than 70% of stroke patients show various degrees of neural function impairment. Motor rehabilitation in acute phase is beneficial for improving patient's structure and function of corticospinal tract. However, it is difficult to obtain effective rehabilitation during the acute phase of stroke because of the insufficiency of professional rehabilitation therapists in stroke wards in China.The present study is to verify that nursing-directed rehabilitation can compensate for the shortage of professional rehabilitation therapists. Our previous study indicated that nursing-directed motor function rehabilitation provided more obvious effect on stroke patients with a weighted corticospinal tract lesion load (wCST-LL) smaller than 2ml. We assume that implementing rehabilitation nursing based on the wCST-LL can realize nursing-directed, wCST-LL-based precision motor rehabilitation during acute phase of ischemic stroke.The present study is to conduct randomized clinical trial to confirm the effect of nursing-directed precision rehabilitation for motor function in acute stroke patients grouped by wCST-LL, and to evaluate the effect of this precision rehabilitation by using functional scale, and to explore the histopathologic mechanism of the precision rehabilitation nursing by mean of neuroelectrophysiology and neuroimaging examination. This study might provide theoretical support for motor rehabilitation in patients during acute phase of stroke.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

212

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • Second Affiliated Hospital, School of Medicine, Zhejiang University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • the patients were diagnosed as ischemic stroke by CT or MRI and met the diagnostic criteria of World Health Organization(WHO);
  • First stroke, within 7 days, with limb dysfunction (muscle strength < 5 grade);
  • there was no contraindication sign of MRI and transcranial magnetic stimulation(TMS) examination, and the examination was completed with good image quality and complete clinical data;
  • 18≤ages≤90;
  • consciousness

Exclusion Criteria:

  • the blood vessels are reconnected after thrombolysis;
  • there are serious cardiopulmonary dysfunction, history of craniocerebral trauma, and other diseases affecting the affected side

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Patients in experimental group were graded with modified Barthel index score, and according to the functional score of patients, the corresponding rehabilitation method was selected for functional rehabilitation from functional rehabilitation nursing program,twice a day with 30 min each time, last 1 week.
Other: functional rehabilitation nursing program
According to the modified Barthel index score, the patients' function was divided into four parts Level,each level has different kinds of rehabilitation nursing.
Experimental: control group
Patients in control group were given conventional bedside rehabilitation ,twice a day with 30 min each time, last 1 week.
Other: control group
The rehabilitation were given by the rehabilitation therapist based on the patient's condition, such as, bridge movement,limb passive motion, limb active motion,turn over,sit upw,walk, and so on.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of motor function
Time Frame: 0 week and 1 week
use Modified Barthel scale to evaluate the change of motor function,The scale were measure the function of the stroke patients,the scale have 100 scores,the function is better if the scores were higher.
0 week and 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of neuroelectric physiological parameters
Time Frame: 0 week and 1 week
use the transcranial Magnetic Stimulation to evaluate the function of Corticospinal Tract
0 week and 1 week

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of neuroimaging quantitative parameters
Time Frame: 0 week and 12 weeks
use the Diffusion Weighted Imaging and Diffusion Tensor Imaging to evaluate the function of Corticospinal Tract
0 week and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Principal Investigator: Jingfen Jin, Master, The Second Affiliated Hospital of Medical College of Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2018

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

August 26, 2018

First Submitted That Met QC Criteria

October 8, 2018

First Posted (Actual)

October 11, 2018

Study Record Updates

Last Update Posted (Actual)

February 12, 2020

Last Update Submitted That Met QC Criteria

February 11, 2020

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 81871839

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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