- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07509944
A Functional Near- Infrared Spectroscopy Study on the Brain Activation Characteristics of Stroke Patients During Mirror Movement
After the selected patients are determined, the researchers of this study need to have full communication with the patients. The location is the rehabilitation ward of our hospital and the time is
Before joining the group. During this process, the patient should be informed of the purpose, procedures and processes of the trial. The informed consent form should be signed by the patient himself/herself. Such as the patient
Illiterate, the informed consent process was witnessed by an independent witness and signed. The subject pressed their fingerprint at the signature. In the study process fully
Listen to and respond to the questions and opinions of the subjects or their representatives.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jiasheng Zhu, Bachelor's
- Phone Number: +86 15157177433
- Email: zhujiasheng321@sina.com
Study Contact Backup
- Name: Yifei Xia, master's
- Phone Number: +86 19816890266
- Email: 2523084@zju.edu.cn
Study Locations
-
-
-
Hangzhou, China
- Recruiting
- The Second Affiliated Hospital of Zhejiang University School of Medicine
-
Contact:
- Jiasheng Zhu
- Phone Number: 15157177433
- Email: zhujiasheng321@sina.com
-
Contact:
- Yifei Xia
- Phone Number: 19816890266
- Email: 2523084@zju.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- It meets the diagnostic criteria of the "Guidelines for the Prevention and Treatment of Cerebrovascular Diseases in China", and is diagnosed as cerebral infarction or cerebral hemorrhage by CT or MRI.
- The first stroke occurred;
- The muscle strength of the flexor and extensor muscles of the affected finger is ≤ grade 1.
- Right-handed player
- Muscle tone improvement: Asworth level 2 or below;
- The disease course is within 6 months and the condition is stable.
- Age: 18 to 75 years old, with normal vision and hearing or corrected to normal.
Exclusion Criteria:
- Those with an MMSE score less than 20, severe memory, communication and speech command comprehension disorders, and those who cannot cooperate with examinations and treatments;
- Those with a history of epilepsy;
- Those with a history of stroke, traumatic brain injury or brain tumor in the past;
- Those with peripheral nervous system injuries other than stroke as diagnosed by imaging;
- Those with visual spatial impairments such as visual field defects and unilateral neglect;
- Skull defect or metal bone plates
- For those who are not suitable for functional near-infrared examination;
- Those with a history of intracranial surgery.
- Patients with lesion areas in the cerebellum or brainstem.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
normal hand movement
|
Patient will be asked to quickly open and grasp the healthy hand, and keep their eyes on the affected hand.
|
|
mirror hand movement
|
Patients will be asked to place the affected hand in the mirror box.
While quickly opening and closing the healthy hand, they should observe the reflection of the healthy hand in the mirror and imagine the affected hand doing the same movements.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
fNIRS measured brain activation
Time Frame: The measurement of the primary outcome indicators occurred after the patients had received one week of hand function rehabilitation training.
|
The measurement of the primary outcome indicators occurred after the patients had received one week of hand function rehabilitation training.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- yan-2025-0018
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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