Effectiveness and Safety of Single Lower Limb Rehabilitation Training Robot in Stroke Patients With Hemiplegia

NCT ID: NCT05360017

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-02
• Study Completion Date: 2022-06-20

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 experimental group adopts litestepper single lower limb rehabilitation training robot walking training on the basis of routine rehabilitation management of stroke patients with hemiplegia, walking training once a day, 40 ± 5 minutes each time; The control group was treated with routine rehabilitation management of stroke patients with hemiplegia. The trial was an open design. Both researchers and subjects knew the treatment allocation and conducted three evaluations within 21 days to evaluate the effectiveness and safety of litestepper single lower limb rehabilitation training robot in the training of lower limb motor function of stroke patients with hemiplegia.

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, so as to drive the movement of the single lower limb rehabilitation training robot and drive the patient's affected side limb to carry out the rehabilitation training suitable for the healthy side limb, which can enable the patient to complete the normal walking process and achieve the purpose of auxiliary rehabilitation. Through long-term walking rehabilitation, patients can gradually recover their normal walking gait.

Conditions

Hemiplegia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Robot in lower limb motor function training of stroke patients with hemiplegia

Test equipment: litestepper single lower limb rehabilitation training robot

Device type: Class II medical device

Group Type: EXPERIMENTAL

litestepper single lower limb rehabilitation training robot

Intervention Type: DEVICE

The experimental group adopts litestepper single lower limb rehabilitation training robot walking training on the basis of routine rehabilitation management of stroke patients with hemiplegia, walking training once a day, 40 ± 5 minutes each time; The control group was treated with routine rehabilitation management of stroke patients with hemiplegia. The trial was an open design. Both researchers and subjects knew the treatment allocation and conducted three evaluations within 21 days to evaluate the effectiveness and safety of litestepper single lower limb rehabilitation training robot in the training of lower limb motor function of stroke patients with hemiplegia.

Interventions

litestepper single lower limb rehabilitation training robot

The experimental group adopts litestepper single lower limb rehabilitation training robot walking training on the basis of routine rehabilitation management of stroke patients with hemiplegia, walking training once a day, 40 ± 5 minutes each time; The control group was treated with routine rehabilitation management of stroke patients with hemiplegia. The trial was an open design. Both researchers and subjects knew the treatment allocation and conducted three evaluations within 21 days to evaluate the effectiveness and safety of litestepper single lower limb rehabilitation training robot in the training of lower limb motor function of stroke patients with hemiplegia.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ying Jin, Master

Role: PRINCIPAL_INVESTIGATOR

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Locations

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

2021-230

Identifier Type: -

Identifier Source: org_study_id