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

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

Sponsors

Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Source Second Affiliated Hospital, School of Medicine, Zhejiang University
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.

Overall Status Recruiting
Start Date November 21, 2018
Completion Date December 31, 2021
Primary Completion Date December 31, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change of motor function 0 week and 1 week
Secondary Outcome
Measure Time Frame
Change of neuroelectric physiological parameters 0 week and 1 week
Enrollment 212
Condition
Intervention

Intervention Type: Other

Intervention Name: functional rehabilitation nursing program

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.

Arm Group Label: Experimental group

Intervention Type: Other

Intervention Name: control group

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.

Arm Group Label: control group

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
jingfen Jin, Master Principal Investigator The second affiliated hospital of medical college of zhejiang university
Overall Contact

Last Name: Jingfen Jin, Master

Phone: 0571-87783887

Email: [email protected]

Location
Facility: Status: Contact: Second Affiliated Hospital, School of Medicine, Zhejiang University Jingfen Jin, Master 0571-87783887 [email protected]
Location Countries

China

Verification Date

August 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Experimental group

Type: Experimental

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.

Label: control group

Type: Experimental

Description: Patients in control group were given conventional bedside rehabilitation ,twice a day with 30 min each time, last 1 week.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov