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

NCT05360017 | Completed

• 1 other identifier: 2021-230
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiplegia

Keywords

hemiplegia

Outcome Measures

Primary Outcomes (1)

• 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 ）

Study Arms (1)

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

EXPERIMENTAL

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

Device: litestepper single lower limb rehabilitation training robot

Interventions

litestepper single lower limb rehabilitation training robot 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.

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• understand the whole process of the experiment, voluntarily participate and sign the informed consent;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

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

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ying Jin, Master

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: multicenter, randomized, controlled, excellent effect, open trial design

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: May 4, 2022
• Study Start: December 2, 2021
• Primary Completion: June 20, 2022
• Study Completion: June 20, 2022
• Last Updated: August 14, 2023

Record last verified: 2021-10

Locations

CN (1)