Study on the Correlation Between Neurotrophic Factors and the Condition of Stroke Patients
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
acupuncture
computerized cognitive training system
aerobic exercise
tranditional cognitive training
Conventional treatment
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
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.
Sites / Locations
- Yongchuan Hospital of Chongqing Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Sham Comparator
Placebo Comparator
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Arm Label
acupuncture stroke group
sham acupuncture stroke group
no acupuncture stroke group
acupuncture healthy group
computerized cognitive training group
tranditional cognitive training group
aerobics group
Arm Description
Outcomes
Primary Outcome Measures
modified rankin scale
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
modified rankin scale
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
modified rankin scale
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
modified rankin scale
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
modified rankin scale
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 Outcome Measures
Mini-mental State Examination
The MMSE (Mini-mental State Examination) is a scale that assesses patients' cognition in terms of calculation, orientation, memory, and recall on a scale of 0-30, which is combined with the patient's level of education to yield results for different levels of cognitive impairment.
Full Information
NCT ID
NCT05479903
First Posted
July 21, 2022
Last Updated
July 27, 2022
Sponsor
Chongqing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05479903
Brief Title
Study on the Correlation Between Neurotrophic Factors and the Condition of Stroke Patients
Official Title
Clinical Study of the Relationship Between Different Interventions for Post-stroke Functional Impairment and Neurotrophic Factors
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chongqing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
acupuncture stroke group
Arm Type
Experimental
Arm Title
sham acupuncture stroke group
Arm Type
Sham Comparator
Arm Title
no acupuncture stroke group
Arm Type
Placebo Comparator
Arm Title
acupuncture healthy group
Arm Type
Placebo Comparator
Arm Title
computerized cognitive training group
Arm Type
Experimental
Arm Title
tranditional cognitive training group
Arm Type
Placebo Comparator
Arm Title
aerobics group
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
acupuncture
Intervention Description
Manual acupuncture or electro-acupuncture by experienced acupuncturists for patients
Intervention Type
Behavioral
Intervention Name(s)
computerized cognitive training system
Intervention Description
One-on-one cognitive training by an experienced cognitive therapist, combined with an existing computerized cognitive training system
Intervention Type
Behavioral
Intervention Name(s)
aerobic exercise
Intervention Description
Patients are trained by experienced physical therapists with the help of elastic bands and physical therapy devices
Intervention Type
Behavioral
Intervention Name(s)
tranditional cognitive training
Intervention Description
One-on-one cognitive training with an experienced cognitive therapist, combined with traditional cognitive training methods (e.g., balls, cards, counting, daily conversation, etc.)
Intervention Type
Other
Intervention Name(s)
Conventional treatment
Intervention Description
Treatment of underlying disease and stroke according to guidelines, as well as necessary care and rehabilitation
Primary Outcome Measure Information:
Title
modified rankin scale
Description
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
Time Frame
Change of the score of modified rankin scale from Baseline at 1 week after onset of disease
Title
modified rankin scale
Description
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
Time Frame
Change of the score of modified rankin scale from Baseline at 2 weeks after onset of disease
Title
modified rankin scale
Description
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
Time Frame
Change of the score of modified rankin scale from Baseline at 1 month after onset of disease
Title
modified rankin scale
Description
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
Time Frame
Change of the score of modified rankin scale from Baseline at 2 months after onset of disease
Title
modified rankin scale
Description
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
Time Frame
Change of the score of modified rankin scale from Baseline at 3 months after onset of disease
Secondary Outcome Measure Information:
Title
Mini-mental State Examination
Description
The MMSE (Mini-mental State Examination) is a scale that assesses patients' cognition in terms of calculation, orientation, memory, and recall on a scale of 0-30, which is combined with the patient's level of education to yield results for different levels of cognitive impairment.
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lingcong Li, M.S. in Medicine
Phone
+8602385381636
Email
molly2816@163.com
Facility Information:
Facility Name
Yongchuan Hospital of Chongqing Medical University
City
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lingcong Li, M.S. in Medicine
Phone
+8602385381636
Email
molly2816@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Study on the Correlation Between Neurotrophic Factors and the Condition of Stroke Patients
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