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| Name | Class |
|---|---|
| Zhejiang Hospital | OTHER |
| Zhejiang Provincial Tongde Hospital | OTHER |
| Zhejiang University | OTHER |
| Sir Run Run Shaw Hospital |
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The main purpose of this clinical trial is to evaluate the effectiveness and safety of the MI-R1 walking machine in lower limb motor function training for stroke patients.
The main question is to answer:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | Patients received MI-R1 lower limb walking machine assisted training device based on their condition for the following training content:
|
|
| control group | Active Comparator | Patients received walking rehabilitation training under the guidance of therapists based on their condition for the following training content:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MI-R1 lower limb walking machine assisted training device | Device | The training is conducted under partial weight support training conditions, performing passive movements on the lower limbs through motor drive, improving the joint activity of the patient's hip and knee joints, and achieving sitting, standing, and walking functions. |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl Meyer Lower Limb Balance Assessment Scale Score on the 28th day | Lower limb function assessment | through study completion, an average of one and a half year |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl Meyer Lower Limb Balance Assessment Scale Score on the 0th and 14th day | Lower limb function assessment | through study completion, an average of one and a half year |
| Holden Walking Function Classification |
| Measure | Description | Time Frame |
|---|---|---|
| Vital signs - temperature | Measure the patient's body temperature on the 0th, 14th, and 28th days of training | through study completion, an average of one and a half year |
| Vital signs - heart rate | Measure the patient's heart rate on the 0th, 14th, and 28th days of training |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qinglong Gao | Zhejiang Fubon Technology Co., Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Hospital | Hangzhou | Zhejiang | 310000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41265879 | Derived | Xiong B, Wang X, Xu X, Lou Z, Tong T, Gu D, Zhang K, Liu H. Effectiveness and safety of a lower-limb walking assist device for motor function recovery in subacute stroke patients: A prospective, randomized, open, parallel-controlled, noninferiority study. J Int Med Res. 2025 Nov;53(11):3000605251396301. doi: 10.1177/03000605251396301. Epub 2025 Nov 20. |
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| OTHER |
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|
| Walking rehabilitation training under the guidance of therapists | Other | Each patient undergoes training under the guidance of a rehabilitation therapist |
|
Pedestrian function assessment on the 0th,14th and 28th day
| through study completion, an average of one and a half year |
| Modified Barthel Index | Assessment of activities of daily living ability on the 0th,14th and 28th day | through study completion, an average of one and a half year |
| through study completion, an average of one and a half year |
| Vital signs - respiratory rate | Measure the patient's respiratory rate on the 0th, 14th, and 28th days of training | through study completion, an average of one and a half year |
| Vital signs - blood pressure | Measure the patient's blood pressure on the 0th, 14th, and 28th days of training | through study completion, an average of one and a half year |
| Vital signs - pulse | Measure the patient's pulse on the 0th, 14th, and 28th days of training | through study completion, an average of one and a half year |
| Adverse events | Number of participants with treatment-related adverse events as assessed by "Criteria for determining adverse events" | through study completion, an average of one and a half year |
| Device defects checklist | The risks to health and safety that may arise from the normal use of medical devices, including quality and malfunctions | through study completion, an average of one and a half year |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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