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RECRUITING

NCT06543758

PHASE4

Effectiveness and Safety of At-home Gait Rehabilitation Using Wearable Exoskeletal Robot

Sponsor: Yonsei University

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to evaluate the effectiveness and safety of a home-based robotic-assisted gait rehabilitation service using a wearable exoskeletal robot for stroke patients. The main questions it aims to answer are: * Can home-based robotic-assisted gait training improve walking speed in stroke patients? * Does this intervention enhance body composition, gait patterns, balance in participants? * How satisfied are participants with the use of the wearable exoskeletal robot ? Researchers will compare pre- and post-intervention walking speeds, body composition, spatiotemporal parameters, balance, and satisfaction survey and does not establish a control group. Participants will: * Wear a wearable exoskeletal robot for gait training. * Undergo 10 sessions of 30-minute gait training over 4 weeks at home or in nearby indoor spaces. * Participate in physical function assessments including the 10-meter walk test, Timed Up and Go (TUG) test, and Berg Balance Scale before and after the intervention. * Complete quality of life and depression inventories before and after the intervention.

Official title: Study to Verify Effectiveness and Safety of At-home Gait Rehabilitation Using Wearable Exoskeletal Robot to Improve Gait in Stroke Patients, Investigator Initiated, Single Center, Single Group Trial

Key Details

Gender

All

Age Range

19 Years - 79 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-08-01

Completion Date

2026-07-31

Last Updated

2024-11-19

Healthy Volunteers

Conditions

Stroke Gait, Spastic Gait, Hemiplegic

Interventions

DEVICE

Wearable exoskeletal robot

Participants will wear a wearable exoskeletal robot for gait training and undergo 10 sessions of 30-minute gait training over 4 weeks at home or in nearby indoor spaces. Participants will participate in physical function assessments, including the 10-meter walk test, Timed Up and Go (TUG) test, and Berg Balance Scale, both before and after the intervention. Additionally, participants will complete quality of life and depression inventories before and after the intervention.

Inclusion Criteria: 1. adults aged 19 to 79 years (based on the age on their national ID at the time of consent) 2. individuals diagnosed with cerebral infarction or intracerebral hemorrhage confirmed by MRI or CT. 3. patients who have passed at least one month since stroke diagnosis. 4. individuals exhibiting spastic hemiplegic gait patterns due to stroke. 5. patients with a Functional Ambulatory Category score of less than 4. 6. individuals who can sit on the edge of a bed without assistance and stand for 10 seconds with or without assistance. 7. individuals with sufficient cognitive ability to follow simple instructions and understand the study's content and purpose (Mini-Mental State Examination score \>= 20) Exclusion Criteria: 1. individuals with severe joint contractures or osteoporosis, or untreated fractures that contraindicate weight-bearing on the lower limbs. 2. individuals with skin conditions or open wounds that prevent device usage. 3. individuals with significant differences in leg length. 4. individuals with severe deformities or joint contractures in the lower limbs. 5. individuals at high risk of fractures due to conditions like osteoporosis. 6. individuals unable to maintain a sitting or standing position independently. 7. individuals with severe lower limb spasticity (Modified Ashworth Scale grade 2 or higher). 8. individuals with severe cognitive impairment (Mini-Mental State Examination score \< 20), delirium, or severe language impairment that hinders cooperation with wearable exoskeletal robot gait training. 9. individuals unable to maintain prolonged standing or walking due to conditions like orthostatic hypotension or cardiopulmonary impairment. 10. individuals with conditions affecting gait, such as peripheral neuropathy, Parkinsonism, or those with alcohol dependence or severe diabetes. 11. pregnant women or those who could become pregnant. 12. individuals participating in other clinical trials. 13. individuals at high risk of falls or bleeding due to conditions like coagulopathies. 14. individuals shorter than 140 cm, taller than 190 cm, or weighing over 80 kg. 15. individuals with other clinical findings deemed inappropriate for the study by the principal investigator or study coordinator.

Locations (1)

Yongin Severance Hospital

Yongin-si, Gyeonggi-do, South Korea