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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 79
Healthy Volunteers: f
View:

• adults aged 19 to 79 years (based on the age on their national ID at the time of consent)

• individuals diagnosed with cerebral infarction or intracerebral hemorrhage confirmed by MRI or CT.

• patients who have passed at least one month since stroke diagnosis.

• individuals exhibiting spastic hemiplegic gait patterns due to stroke.

• patients with a Functional Ambulatory Category score of less than 4.

• individuals who can sit on the edge of a bed without assistance and stand for 10 seconds with or without assistance.

• individuals with sufficient cognitive ability to follow simple instructions and understand the study's content and purpose (Mini-Mental State Examination score \>= 20)

Locations
Other Locations
Republic of Korea
Yongin Severance Hospital
RECRUITING
Yongin-si
Contact Information
Primary
Na Young Kim, MD, PhD
kny8452@yuhs.ac
+82 010 9127 4482
Backup
Seung Ick Choi
rehab1@yuhs.ac
+82 010 8821 5297
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 16
Treatments
Experimental: Wearable exoskeletal robot group
Patients with stroke receive home-based robotic-assisted gait rehabilitation using a wearable exoskeletal robot.
Related Therapeutic Areas
Sponsors
Leads: Yonsei University

This content was sourced from clinicaltrials.gov