Study on the Correlation Between Neurotrophic Factors and the Condition of Stroke Patients

NCT05479903 | Unknown

• 1 other identifier: 2021kelunshen110
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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).

Conditions

Stroke

Outcome Measures

Primary Outcomes (5)

• 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

  Change of the score of modified rankin scale from Baseline at 1 week after onset of disease

• 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

  Change of the score of modified rankin scale from Baseline at 2 weeks after onset of disease

• 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

  Change of the score of modified rankin scale from Baseline at 1 month after onset of disease

• 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

  Change of the score of modified rankin scale from Baseline at 2 months after onset of disease

• 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

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

Secondary Outcomes (1)

• 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

Study Arms (7)

acupuncture stroke group

EXPERIMENTAL

Procedure: acupuncture; Other: Conventional treatment

sham acupuncture stroke group

SHAM COMPARATOR

Other: Conventional treatment

no acupuncture stroke group

PLACEBO COMPARATOR

Other: Conventional treatment

acupuncture healthy group

PLACEBO COMPARATOR

Procedure: acupuncture

computerized cognitive training group

EXPERIMENTAL

Behavioral: computerized cognitive training system; Other: Conventional treatment

tranditional cognitive training group

PLACEBO COMPARATOR

Behavioral: aerobic exercise; Other: Conventional treatment

aerobics group

EXPERIMENTAL

Behavioral: tranditional cognitive training; Other: Conventional treatment

Interventions

acupuncture PROCEDURE

Manual acupuncture or electro-acupuncture by experienced acupuncturists for patients

acupuncture healthy group; acupuncture stroke group

computerized cognitive training system BEHAVIORAL

One-on-one cognitive training by an experienced cognitive therapist, combined with an existing computerized cognitive training system

computerized cognitive training group

aerobic exercise BEHAVIORAL

Patients are trained by experienced physical therapists with the help of elastic bands and physical therapy devices

tranditional cognitive training group

tranditional cognitive training BEHAVIORAL

One-on-one cognitive training with an experienced cognitive therapist, combined with traditional cognitive training methods (e.g., balls, cards, counting, daily conversation, etc.)

aerobics group

Conventional treatment OTHER

Treatment of underlying disease and stroke according to guidelines, as well as necessary care and rehabilitation

acupuncture stroke group; aerobics group; computerized cognitive training group; no acupuncture stroke group; sham acupuncture stroke group; tranditional cognitive training group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chongqing Medical University: lead

Study Sites (1)

Yongchuan Hospital of Chongqing Medical University

Chongqing, China

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Acupuncture Therapy; Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Lingcong Li, M.S. in Medicine

CONTACT

+8602385381636; molly2816@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.S. in Medicine

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: July 29, 2022
• Study Start: November 16, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)