A Study on the Effectiveness Evaluation in Stroke Patients Using Lower Limb Assistive Walking Devices
NCT Number: NCT06564480
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke
Interventions: DEVICE: MI-R1 lower limb walking machine assisted training device|OTHER: Walking rehabilitation training under the guidance of therapists
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators: Zhejiang Hospital|Zhejiang Provincial Tongde Hospital|Zhejiang University|Sir Run Run Shaw Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-05-24
Completion Date: 2024-02-01
Locations: Zhejiang Hospital, Hangzhou, Zhejiang, 310000, China

Summary:
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:

1. Are patients using MI-R1 lower limb walking machine training more effective than those using traditional rehabilitation training?
2. Is the MI-R1 lower limb walking machine safe?

Participants will:

1. The experimental group received MI-R1 lower limb walking machine assisted training, while the control group received traditional rehabilitation training.
2. Perform functional testing on the 0th, 14th, and 28th day of training.
3. Observe whether there is any discomfort or safety during the rehabilitation training process.

Primary Outcome Measures: 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
Secondary Outcome Measures: 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, 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
Other Outcome Measures: 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, 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