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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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31 August 2020 |
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Main ID: |
ChiCTR2000035872 |
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Date of registration:
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2020-08-19 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of repetitive transcranial magnetic stimulation on gait and balance function in patients with Parkinson's disease and Parkinson's syndrome
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Scientific title:
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Effect of repetitive transcranial magnetic stimulation on gait and balance function in patients with Parkinson's disease and Parkinson's syndrome |
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Date of first enrolment:
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2020-09-01 |
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Target sample size:
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Parkinson's disease observation group:28;Parkinson's disease control group:28;Parkinson's syndrome observation group:28;Parkinson's syndrome control group:28; |
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Recruitment status: |
Pending |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=57437 |
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Study type:
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Interventional study |
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Study design:
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Parallel
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Phase:
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0
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Countries of recruitment
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China
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Contacts
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Name:
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Weijing Zhao
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Address:
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204 Chengguan District, Lanzhou, Gansu, China
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Telephone:
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+86 931-8281452 |
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Email:
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29347170@qq.com |
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Affiliation:
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Gansu Provincial Hospital |
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Name:
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Weijing Zhao
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Address:
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204 Chengguan District, Lanzhou, Gansu, China
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Telephone:
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+86 931-8281452 |
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Email:
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29347170@qq.com |
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Affiliation:
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Gansu Provincial Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Parkinson's disease group (PD group)
(1) The onset was slow and the course of disease was more than 3 years;
(2) Static tremor, dyskinesia or ankylosis occurred at least 2 items;
(3) Levodopa treatment has a response;
(4) The blood pressure was stable (100-160 / 60-100mmhg);
(5) Agree to carry out systematic cognitive and motor function evaluation, be able to understand the instructions of the therapist or instrument, and be able to complete the required actions.
(6) It was approved by the ethics committee of Gansu Provincial People's hospital. They agreed to participate in the study and signed the informed consent.
2. Parkinson's syndrome group (PS group)
(1) There are manifestations of Parkinson's syndrome, that is, must have slow movement, and have one of the following symptoms: static tremor, myotonia and postural instability. Postural instability is excluded from primary visual, vestibular, cerebellar and proprioception abnormalities.
(2) With the performance of cerebrovascular disease, can be the performance of brain imaging, can also be caused by stroke focal symptoms and signs.
(3) There must be a correlation between (1) and (2): acute onset after stroke or progressive appearance of Parkinson's syndrome within one year. The affected areas of stroke mainly cause the motor output function of basal ganglia (lateral part of globus pallidus or substantia nigra compacta) or decreased function of thalamic cortical pathway (ventroposterior lateral nucleus of thalamus, greater frontal lobe) The results showed that the main manifestation of the contralateral limb was Parkinson's syndrome with less movement and rigidity; latent onset, early gait disorder or cognitive dysfunction caused by subcortical white matter damage.
(4) The blood pressure was stable (100-160 / 60100 mmHg);
(5) Agree to carry out systematic cognitive and motor function evaluation, be able to understand the instructions of the therapist or instrument, and be able to complete the required actions.
(6) It was approved by the ethics committee of Gansu Provincial People's hospital. They agreed to participate in the study and signed the informed consent.
Exclusion criteria: 1. Parkinson's disease group (PD group)
(1) Parkinson's syndrome and Parkinson's syndrome;
(2) Those who place metal objects inside the body;
(3) Patients with history of epilepsy;
(4) Other serious physical or mental diseases.
2. Parkinson's syndrome group (PS group)
(1) Keywords recurrent craniocerebral trauma; definite diagnosis of encephalitis;
(2) There was a history of antipsychotics at the onset of the disease;
(3) MRI or CT confirmed brain tumor or communicating hydrocephalus;
(4) Parkinson's syndrome caused by other reasons.
(5) Patients with Parkinson's disease;
(6) Those who place metal objects inside the body;
(7) Patients with history of epilepsy;
(8) Other serious physical or mental diseases.
Age minimum:
50
Age maximum:
85
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Parkinson's disease and Parkinson's syndrome
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Intervention(s)
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Parkinson's disease observation group:Repetitive transcranial magnetic stimulation+Visual feedback balance training system+Digital treadmill ;Parkinson's disease control group:Visual feedback balance training system+Digital treadmill;Parkinson's syndrome observation group:Repetitive transcranial magnetic stimulation+Visual feedback balance training system+Digital treadmill;Parkinson's syndrome control group:Visual feedback balance training system+Digital treadmill ;
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Primary Outcome(s)
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Trajectory lengths;Elliptical trajectory;Tinetti score;step length;Step width;Vertical displacement of gravity center;
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Source(s) of Monetary Support
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Internal medicine research fund project of Gansu Provincial People's Hospital
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Ethics review
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Status: Approved
Approval date: 01/07/2020
Contact:
Hui Cai
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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