The Effect and Mechanism of wCST-LL Based Precision Rehabilitation Nursing on Motor Dysfunction After Acute Stroke
1 other identifier
interventional
212
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2018
CompletedFirst Posted
Study publicly available on registry
October 11, 2018
CompletedStudy Start
First participant enrolled
November 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedFebruary 12, 2020
August 1, 2019
2.1 years
August 26, 2018
February 11, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
0 week and 1 week
Secondary Outcomes (1)
Change of neuroelectric physiological parameters
0 week and 1 week
Other Outcomes (1)
Change of neuroimaging quantitative parameters
0 week and 12 weeks
Study Arms (2)
Experimental group
EXPERIMENTALPatients 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.
control group
EXPERIMENTALPatients in control group were given conventional bedside rehabilitation ,twice a day with 30 min each time, last 1 week.
Interventions
According to the modified Barthel index score, the patients' function was divided into four parts Level,each level has different kinds of rehabilitation nursing.
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.
Eligibility Criteria
You may qualify if:
- 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;
- ≤ages≤90;
- consciousness
You may not qualify if:
- the blood vessels are reconnected after thrombolysis;
- there are serious cardiopulmonary dysfunction, history of craniocerebral trauma, and other diseases affecting the affected side
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009, China
Related Publications (1)
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.
PMID: 32978194DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
jingfen Jin, Master
The Second Affiliated Hospital of Medical College of Zhejiang University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2018
First Posted
October 11, 2018
Study Start
November 21, 2018
Primary Completion
December 31, 2020
Study Completion
December 31, 2021
Last Updated
February 12, 2020
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share