NCT06543758

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

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Detailed description

After obtaining informed consent, a screening test is conducted. The screening test includes a review of the participant's baseline symptoms and signs, medical history, and medication usage, followed by a physical examination and assessment of gait status, including the use of assistive devices and gait patterns. Participants who pass the screening test undergo an initial assessment within seven days. The initial assessment includes physical function tests such as the 10-meter walk test, the Timed Up and Go (TUG) test, and the Berg Balance Scale, along with quality of life and Beck Depression Inventory assessments. Participants who complete the initial assessment begin robotic-assisted gait training within two days. The training is conducted using a wearable exoskeletal robot for gait training at home or in nearby indoor spaces. The training lasts for four weeks, with sessions held 2-3 times per week, totaling 10 sessions, each lasting 30 minutes. After four weeks, the robotic-assisted gait training concludes, and within two days, an endpoint assessment identical to the initial assessment is performed. Satisfaction with the wearable exoskeletal robot is also evaluated. Any device malfunctions are addressed and documented. The usage and satisfaction levels of the wearable exoskeletal robot are analyzed, and pre- and post-training assessment metrics are compared.

Conditions

• Stroke
• Gait, Spastic
• Gait, Hemiplegic

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-07-31
• Completion: 2026-07-31
• First posted: 2024-08-09
• Last updated: 2024-11-19

Locations

1 site across 1 country: South Korea