A Study on the Effectiveness Evaluation in Stroke Patients Using Lower Limb Assistive Walking Devices
NCT06564480 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2024-08-21
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.
Conditions
Interventions
- DEVICE
-
MI-R1 lower limb walking machine assisted training 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.
- OTHER
-
Walking rehabilitation training under the guidance of therapists
Each patient undergoes training under the guidance of a rehabilitation therapist
Sponsors & Collaborators
-
Zhejiang Hospital
collaborator OTHER -
Zhejiang Provincial Tongde Hospital
collaborator OTHER -
Zhejiang University
collaborator OTHER -
Sir Run Run Shaw Hospital
collaborator OTHER -
Second Affiliated Hospital, School of Medicine, Zhejiang University
lead OTHER
Principal Investigators
-
Qinglong Gao · Zhejiang Fubon Technology Co., Ltd
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-05-24
- Primary Completion
- 2024-02-01
- Completion
- 2024-02-01
Countries
- China
Study Locations
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