The Effect and Mechanism of wCST-LL Based Precision Rehabilitation Nursing on Motor Dysfunction After Acute Stroke
Primary Purpose
Acute Ischemic Stroke
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
functional rehabilitation nursing program
control group
Sponsored by
About this trial
This is an interventional treatment trial for Acute Ischemic Stroke
Eligibility Criteria
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
Sites / Locations
- Second Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Experimental group
control group
Arm Description
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.
Patients in control group were given conventional bedside rehabilitation ,twice a day with 30 min each time, last 1 week.
Outcomes
Primary Outcome Measures
Change of motor function
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.
Secondary Outcome Measures
Change of neuroelectric physiological parameters
use the transcranial Magnetic Stimulation to evaluate the function of Corticospinal Tract
Full Information
NCT ID
NCT03702452
First Posted
August 26, 2018
Last Updated
February 11, 2020
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT03702452
Brief Title
The Effect and Mechanism of wCST-LL Based Precision Rehabilitation Nursing on Motor Dysfunction After Acute Stroke
Official Title
The Effect and Mechanism of wCST-LL Based Precision Rehabilitation Nursing on Motor Dysfunction After Acute Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 21, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
212 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
Experimental
Arm Description
Patients in control group were given conventional bedside rehabilitation ,twice a day with 30 min each time, last 1 week.
Intervention Type
Other
Intervention Name(s)
functional rehabilitation nursing program
Intervention Description
According to the modified Barthel index score, the patients' function was divided into four parts Level,each level has different kinds of rehabilitation nursing.
Intervention Type
Other
Intervention Name(s)
control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of motor function
Description
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.
Time Frame
0 week and 1 week
Secondary Outcome Measure Information:
Title
Change of neuroelectric physiological parameters
Description
use the transcranial Magnetic Stimulation to evaluate the function of Corticospinal Tract
Time Frame
0 week and 1 week
Other Pre-specified Outcome Measures:
Title
Change of neuroimaging quantitative parameters
Description
use the Diffusion Weighted Imaging and Diffusion Tensor Imaging to evaluate the function of Corticospinal Tract
Time Frame
0 week and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jingfen Jin, Master
Phone
0571-87783887
Email
zrjzkhl@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jingfen Jin, Master
Organizational Affiliation
The Second Affiliated Hospital of Medical College of Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Second Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingfen Jin, Master
Phone
0571-87783887
Email
zrjzkhl@zju.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32978194
Citation
Wang J, Chen Y, Zhang Y, Li M, Jin J. Rehabilitation nursing for motor functional recovery of acute ischaemic stroke: study protocol for a randomised controlled trial. BMJ Open. 2020 Sep 25;10(9):e037391. doi: 10.1136/bmjopen-2020-037391.
Results Reference
derived
Learn more about this trial
The Effect and Mechanism of wCST-LL Based Precision Rehabilitation Nursing on Motor Dysfunction After Acute Stroke
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