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Clinical Trials/NCT05479903
NCT05479903RecruitingNot Applicable

Clinical Study of the Relationship Between Different Interventions for Post-stroke Functional Impairment and Neurotrophic Factors

Chongqing Medical University1 site in 1 country300 target enrollmentStarted: November 16, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
300
Locations
1
Primary Endpoint
modified rankin scale

Study Overview

Brief Summary

Stroke is currently the most common disabling disease, which often leads to impairment of sensory, motor, speech and psychological functions, resulting in a reduced quality of life for patients. Therefore, post-stroke functional rehabilitation, especially the rehabilitation of physical function and psychological condition, is particularly important for patients to rejoin society. Acupuncture can promote the functional recovery of patients and facilitate the rehabilitation of limb function, thus improving the quality of survival of post-stroke patients.

Neurotrophic factors are diverse, most of which are mainly derived from neuronal cells in the central nervous system and are involved in a variety of neurological functions such as cell growth, differentiation and plasticity, thus promoting recovery of multiple functions after stroke. Many studies have found that different interventions affect the prognosis of stroke patients differently, e.g., long-term acupuncture increases serum levels of brain-derived neurotrophic factor in stroke patients and also has better outcomes than controls in post-stroke neurological recovery and the development of post-stroke psychiatric disorders.

This study investigated the effects of different therapeutic measures on patients' functional recovery and neurotrophic factors by setting up a controlled and blinded trial design, which could not only provide clinical evidence for the effectiveness of relevant therapeutic measures, but also verify the clinical value of certain neurotrophic factors (e.g., predicting outcome, assessing condition, and preventing adverse events).

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Symptom recognition to admission ≤ 72 hours
  • Clear imaging evidence
  • Diagnosis of spontaneous cerebral hemorrhage by an immobilized physician according to relevant guidelines; pre-onset mRS score ≤ 1

Exclusion Criteria

  • This onset was caused by traumatic and violent factors
  • History of previous intracranial surgery
  • Previous cerebrovascular accident
  • Previous speech disorders and limb movement disorders
  • Participation in other trials in the last three months.

Outcomes

Primary Outcomes

modified rankin scale

Time Frame: Change of the score of modified rankin scale from Baseline at 3 months after onset of disease

The mrs (modified rankin scale) is a scale used to assess the patient's ability to care for himself/herself, which is composed of independent walking ability, self-perceived symptoms, and ability to control bowel and urine.Assessment results range from 0-6 points,a higher score means a worse ending

Secondary Outcomes

  • Mini-mental State Examination(Change of the score of modified rankin scale from Baseline at 1 week, 2 weeks, 1 month, 2 months, 3 months after onset of disease)

Investigators

Sponsor
Chongqing Medical University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lingcong Li

M.S. in Medicine

Chongqing Medical University

Study Sites (1)

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