Status:
COMPLETED
Effectiveness and Safety of Single Lower Limb Rehabilitation Training Robot in Stroke Patients With Hemiplegia
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Hemiplegia
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This trial is a multi center, randomized, controlled, excellent effect, open and loading trial design. The subjects are randomly assigned to the experimental group and the control group. The experimen...
Detailed Description
By collecting the movement gait information of the patient's healthy side limb, judging the patient's movement intention, analyzing and learning the gait characteristics of the patient's healthy side,...
Eligibility Criteria
Inclusion
- understand the whole process of the experiment, voluntarily participate and sign the informed consent;
- 18-75 years old for both sexes;
- Stable vital signs, stable condition, tolerance to low-intensity sitting and standing training;
- ④ Weight ≤ 100kg, height 1.50M \~ 1.90m;
- ⑤ Patients with stroke hemiplegia diagnosed as the first onset, including cerebral infarction and intracerebral hemorrhage, the course of disease is within one month after the onset;
- ⑥ One level of sitting or standing balance, able to wear a single lower limb rehabilitation training robot with the help of medical staff;
- ⑦ The passive range of motion of hip and knee is not significantly limited, and the passive range of ankle can be kept in neutral position.
Exclusion
- The range of motion of the joint is severely limited and the walking movement is limited;
- Skin injury or infection of the lower limb in contact with the robot;
- History of unstable angina pectoris, severe arrhythmia and other heart diseases;
- ④ History of severe chronic obstructive pulmonary disease;
- ⑤ Other contraindications or complications that may affect walking training;
- ⑥ Pregnant women, women preparing for pregnancy or lactation;
- ⑦ Those who participated in any clinical trial within 1 month before enrollment;
- ⑧ Other circumstances that the researcher believes cannot participate in the clinical trial.
Key Trial Info
Start Date :
December 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2022
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT05360017
Start Date
December 2 2021
End Date
June 20 2022
Last Update
August 14 2023
Active Locations (1)
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1
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, China, 310009