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Research on Clinical Safety and Effectiveness of Wearable Assistive Devices With Flexible Structure for Daily Life Support of Stroke Patients

NCT06549127 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-08-12

No results posted yet for this study

Summary

Gait independence is a critical goal for stroke patients and significantly impacts their return to society. Due to hemiplegia, stroke patients often face walking difficulties. Compensatory approaches using lower limb assistive devices have shown promise in improving independent walking. Wearable assistive devices, which minimize daily life restrictions, are gaining attention globally. Despite the availability of many imported rehabilitation assistive devices, their high cost and poor fit for East Asian patients highlight the need for domestic alternatives. In light of the global interest in robotics, there is a shortage of domestic research on advanced wearable robots. This study aims to clinically test and verify the effectiveness of a flexible, wearable robotic assistive device developed by Angel Robotics for stroke patients.

Conditions

Interventions

DEVICE

Soft Wearable Robot

This study aims to enroll 20 participants who will receive assistance in flexion and extension of the knee and hip during overground walking adaptation training. Following the initial assessment, participants will undergo three 30-minute sessions of overground walking adaptation training with a powered hip assistive device over two weeks. After completing these sessions, Post-intervention Assessment 1 will be conducted. Then, participants will undergo three 30-minute sessions of overground walking adaptation training with a powered knee assistive device over two weeks, followed by Post-intervention Assessment 2. Each participant will have a total of nine visits, including three functional assessments and six adaptation training sessions. The first visit will involve scheduling subsequent visits. The familiarization process will occur two to three times per week, adjustable for participants' convenience, with each set of three visits completed within three weeks.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-15
Primary Completion
2024-05-29
Completion
2024-05-29

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06549127 on ClinicalTrials.gov