Zhejiang Hospital
Hangzhou, Zhejiang, 310000, China
NCT Number: NCT06564480
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.
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Notify Me18 year–85 year
All sexes
Interventional
Not applicable
Hangzhou, Zhejiang, 310000, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Each patient undergoes training under the guidance of a rehabilitation therapist
Time frame: through study completion, an average of one and a half year
Lower limb function assessment
Time frame: through study completion, an average of one and a half year
Lower limb function assessment
Time frame: through study completion, an average of one and a half year
Pedestrian function assessment on the 0th,14th and 28th day
Time frame: through study completion, an average of one and a half year
Assessment of activities of daily living ability on the 0th,14th and 28th day
Time frame: through study completion, an average of one and a half year
Measure the patient's body temperature on the 0th, 14th, and 28th days of training
Time frame: through study completion, an average of one and a half year
Measure the patient's heart rate on the 0th, 14th, and 28th days of training
Time frame: through study completion, an average of one and a half year
Measure the patient's respiratory rate on the 0th, 14th, and 28th days of training
Time frame: through study completion, an average of one and a half year
Measure the patient's blood pressure on the 0th, 14th, and 28th days of training
Time frame: through study completion, an average of one and a half year
Measure the patient's pulse on the 0th, 14th, and 28th days of training
Time frame: through study completion, an average of one and a half year
Number of participants with treatment-related adverse events as assessed by "Criteria for determining adverse events"
Time frame: through study completion, an average of one and a half year
The risks to health and safety that may arise from the normal use of medical devices, including quality and malfunctions
Second Affiliated Hospital, School of Medicine, Zhejiang University
Other
A Prospective, Randomized, Parallel Controlled, Non Inferiority Clinical Trial Evaluating the Effectiveness and Safety of the Walker Assisted Device (Fubon Robot) in Lower Limb Motor Function for Stroke Patients
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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