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

Acute Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03702452
• Other study ID #: 81871839
• Status: Recruiting
• Phase: N/A
• Start date: November 21, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Jingfen Jin, Master
• Phone: 0571-87783887
• Email: zrjzkhl[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 212
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of neuroimaging quantitative parameters	use the Diffusion Weighted Imaging and Diffusion Tensor Imaging to evaluate the function of Corticospinal Tract	0 week and 12 weeks
Primary	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	Change of neuroelectric physiological parameters	use the transcranial Magnetic Stimulation to evaluate the function of Corticospinal Tract	0 week and 1 week