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

A Clinical Trial to Evaluate the Effectiveness and Safety of Single Lower Limb Rehabilitation Training Robot in Lower Limb Motor Function Training of Stroke Patients With Hemiplegia

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.

Study Overview

• Status: Completed
• Conditions: Hemiplegia
• Intervention / Treatment: Device: litestepper single lower limb rehabilitation training robot

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.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Berg balance scale	Berg balance scale .The highest score is 56 points and the lowest score is 0 points. The higher the score, the stronger the balance ability. A score of less than 40 indicates a risk of falling.	Visit three (Day 21 ± 2 ）

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Ying Jin, Master, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2021
• Primary Completion (Actual): June 20, 2022
• Study Completion (Actual): June 20, 2022

Study Registration Dates

• First Submitted: March 31, 2022
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (Actual): May 4, 2022

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: hemiplegia
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paralysis; Hemiplegia
• Other Study ID Numbers: 2021-230

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No