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

Primary Purpose

Hemiplegia

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

litestepper single lower limb rehabilitation training robot

About this trial

This is an interventional treatment trial for Hemiplegia focused on measuring hemiplegia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

Test equipment: litestepper single lower limb rehabilitation training robot Device type: Class II medical device

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05360017

First Posted

March 31, 2022

Last Updated

August 9, 2023

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT05360017

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

December 2, 2021 (Actual)

Primary Completion Date

June 20, 2022 (Actual)

Study Completion Date

June 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemiplegia

Keywords

hemiplegia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

multicenter, randomized, controlled, excellent effect, open trial design

Masking

None (Open Label)

Allocation

N/A

Enrollment

92 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Test equipment: litestepper single lower limb rehabilitation training robot Device type: Class II medical device

Intervention Type

Device

Intervention Name(s)

litestepper single lower limb rehabilitation training robot

Intervention Description

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.

Primary Outcome Measure Information:

Title

The Berg balance scale

Description

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.

Time Frame

Visit three (Day 21 ± 2 ）

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ying Jin, Master

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310009

Country

China

12. IPD Sharing Statement

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

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