Parkinson's disease
Conditions
Interventions
Experimental group:Using a limb function rehabilitation assessment and training system for home gait training
Control group:Perform routine home gait training, including step training, step training, etc
Sponsors
The First Affiliated Hospital,Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed with primary Parkinson's disease according to the "Diagnostic Criteria for Parkinson's Disease in China (2016 Edition)", and with a Mini Mental State Examination (MMSE) score greater than 18 points; 2. The severity of the disease is classified into stages 2-4 according to the revised HOEHN-YAHR (H&Y) staging system; 3. Ability to walk independently for at least 6 minutes; 4. Meet one of the following conditions: (1) The score for item 10 of the MDS-UPDRS-III Unified Parkinson's Disease Rating Scale is = 2, or (2) The total score for items 9 to 13 of the MDS-UPDRS-III Unified Parkinson's Disease Rating Scale is >= 3, or (3) The walking distance in the 6-minute walk test (6MWT) is <= 360m; 5. Age range: 18-75 years old; 6. Ensure stable drug dosage 30 days before and during clinical trials; 7. Women of childbearing age can ensure the use of sufficient and effective contraceptive measures during clinical trials; 8. Voluntarily participate in the experiment and provide a signed informed consent form;
Exclusion criteria
Exclusion criteria: 1. Parkinson's syndrome caused by cerebrovascular disease, traumatic brain injury, intracranial inflammation, intracranial space occupying lesions, hydrocephalus, medication, or other neurological disorders; 2. Parkinson's disease superimposed syndrome (multiple system atrophy, progressive supranuclear paralysis, cortical basal ganglia degeneration, Lewy body dementia, etc.); 3. Parkinson's disease complicated with various mental illnesses; 4. Suffering from other neuromuscular, bone and joint diseases and lower limb vascular disorders that affect walking ability; 5. Suffering from underlying diseases such as severe heart disease, lung disease, etc. that affect exercise ability; 6. Factors that affect participation in clinical research, such as severe hearing impairment, severe visual impairment, and severe dizziness; 7. Postural hypotension (blood pressure drop >= 20/10mmHg within 3 minutes of standing) or baseline blood pressure below 90/60mmHg after standing for 3 minutes; 8. Pregnant or lactating women; 9. Parkinson's disease patients who have undergone neurosurgery such as deep brain stimulation (DBS) surgery;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-minute walking test (6MWT) walking distance; | — |
Secondary
| Measure | Time frame |
|---|---|
| The average step size of the 6-minute walking test (6MWT);Time for TUG single task testing;Time for TUG cognitive dual task test;Time for single leg standing test;FOG-Q rating;MDS-UPDRS-III rating;Safety evaluation of experimental equipment;Adverse event incidence rate; | — |
Countries
China
Contacts
Public ContactJinsheng Zeng
The First Affiliated Hospital,Sun Yat-sen University
Outcome results
None listed