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

NCT06549127 | Completed DMC

• 1 other identifier: 4-2023-0009
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Stroke; Hemiplegia

Outcome Measures

Primary Outcomes (3)

• 10-meter walking test

  The 10 Meter Walk Test (10MWT) is a simple and commonly used assessment to evaluate walking speed. During the test, participants are instructed to walk a distance of 10 meters. The time is measured for the middle 6 meters, allowing the first and last 2 meters for acceleration and deceleration. This approach ensures a more accurate assessment of the participant's steady-state walking speed.

  Initial Assessment

• 10-meter walking test

  The 10 Meter Walk Test (10MWT) is a simple and commonly used assessment to evaluate walking speed. During the test, participants are instructed to walk a distance of 10 meters. The time is measured for the middle 6 meters, allowing the first and last 2 meters for acceleration and deceleration. This approach ensures a more accurate assessment of the participant's steady-state walking speed.

  After 2 weeks of hip assistive device adaptation training

• 10-meter walking test

  The 10 Meter Walk Test (10MWT) is a simple and commonly used assessment to evaluate walking speed. During the test, participants are instructed to walk a distance of 10 meters. The time is measured for the middle 6 meters, allowing the first and last 2 meters for acceleration and deceleration. This approach ensures a more accurate assessment of the participant's steady-state walking speed.

  After 2 weeks of knee assistive device adaptation training

Study Arms (1)

Experimental Group

EXPERIMENTAL

This group is evaluated on three conditions.

Device: Soft Wearable Robot

Interventions

Soft Wearable Robot DEVICE

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.

Experimental Group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Adult patients aged 19 years and older 2. Diagnosed with stroke confirmed by neurologists or neurosurgeons through imaging techniques such as CT or MRI 3. Chronic hemiplegic stroke patients, 6 months or more post-stroke onset 4. Patients with a Functional Ambulatory Category (FAC) score of 3 or higher 5. Patients with a Mini-Mental State Examination (MMSE) score of 10 or higher, who can understand the study, have a voluntary willingness to participate, and have given consent to participate

You may not qualify if:

• \. Acute/subacute stroke patients within 6 months of stroke onset 2. Quadriplegia 3. Ataxia 4. Severe lower limb joint contractures that make wearing the assistive device difficult 5. Patients with neurological, musculoskeletal, or cardiopulmonary diseases that affect walking 6. Any other conditions deemed inappropriate for participation in the study by the researcher

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine

Seoul, South Korea

Location

MeSH Terms

Conditions

Stroke; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 12, 2024
• Study Start: May 15, 2023
• Primary Completion: May 29, 2024
• Study Completion: May 29, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)