StrokeNCT05479903
Study on the Correlation Between Neurotrophic Factors and the Condition of Stroke Patients
A study testing acupuncture, computerized cognitive training system and aerobic exercise in people with Stroke, run by Chongqing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- acupuncture, computerized cognitive training system and aerobic exercise
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 16 Nov 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yongchuan Hospital of Chongqing Medical University
Chongqing
Lingcong Li, M.S. in Medicine, +8602385381636, molly2816@163.com
About this study
Official title: Clinical Study of the Relationship Between Different Interventions for Post-stroke Functional Impairment and Neurotrophic Factors
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
- Being tested
- acupuncture, computerized cognitive training system, aerobic exercise, tranditional cognitive training, Conventional treatment
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureProcedure or surgery
Manual acupuncture or electro-acupuncture by experienced acupuncturists for patients
computerized cognitive training systemBehavioural
One-on-one cognitive training by an experienced cognitive therapist, combined with an existing computerized cognitive training system
aerobic exerciseBehavioural
Patients are trained by experienced physical therapists with the help of elastic bands and physical therapy devices
tranditional cognitive trainingBehavioural
One-on-one cognitive training with an experienced cognitive therapist, combined with traditional cognitive training methods (e.g., balls, cards, counting, daily conversation, etc.)
Conventional treatmentOther
Treatment of underlying disease and stroke according to guidelines, as well as necessary care and rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| acupuncture stroke group | Experimental | Not described Receives: Procedure: acupuncture; Other: Conventional treatment |
| sham acupuncture stroke group | Sham comparator | Not described Receives: Other: Conventional treatment |
| no acupuncture stroke group | Placebo comparator | Not described Receives: Other: Conventional treatment |
| acupuncture healthy group | Placebo comparator | Not described Receives: Procedure: acupuncture |
| computerized cognitive training group | Experimental | Not described Receives: Behavioral: computerized cognitive training system; Other: Conventional treatment |
| tranditional cognitive training group | Placebo comparator | Not described Receives: Behavioral: aerobic exercise; Other: Conventional treatment |
| aerobics group | Experimental | Not described Receives: Behavioral: tranditional cognitive training; Other: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Change of the score of modified rankin scale from Baseline at 3 months after onset of disease
Secondary outcomes (1)
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start16 Nov 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lingcong Li, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479903
- Sponsor's protocol ID
- 2021kelunshen110
- Status last verified
- Jul 2022
- First submitted
- 21 Jul 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Relationship Between Different Interventions for Post-stroke Functional Impairment and Neurotrophic Factors
- ClinicalTrials.gov ID
- NCT05479903
- Acronym / sponsor ID
- 2021kelunshen110
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupunctureManual acupuncture or electro-acupuncture by experienced acupuncturists for patients | Procedure or surgery | acupuncture healthy group, acupuncture stroke group |
| computerized cognitive training systemOne-on-one cognitive training by an experienced cognitive therapist, combined with an existing computerized cognitive training system | Behavioural | computerized cognitive training group |
| aerobic exercisePatients are trained by experienced physical therapists with the help of elastic bands and physical therapy devices | Behavioural | tranditional cognitive training group |
| tranditional cognitive trainingOne-on-one cognitive training with an experienced cognitive therapist, combined with traditional cognitive training methods (e.g., balls, cards, counting, daily conversation, etc.) | Behavioural | aerobics group |
| Conventional treatmentTreatment of underlying disease and stroke according to guidelines, as well as necessary care and rehabilitation | Other | acupuncture stroke group, aerobics group, computerized cognitive training group, no acupuncture stroke group, sham acupuncture stroke group, tranditional cognitive training group |
Primary outcome
modified rankin scale
Time frame: Change of the score of modified rankin scale from Baseline at 1 week 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
modified rankin scale
Time frame: Change of the score of modified rankin scale from Baseline at 2 weeks 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
modified rankin scale
Time frame: Change of the score of modified rankin scale from Baseline at 1 month 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
modified rankin scale
Time frame: Change of the score of modified rankin scale from Baseline at 2 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
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
1 secondary outcome
Mini-mental State Examination
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture, computerized cognitive training system and aerobic exercise in people with Stroke, run by Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lingcong Li, M.S. in Medicine (+8602385381636, molly2816@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified rankin scale (time frame: Change of the score of modified rankin scale from Baseline at 1 week after onset of disease). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.