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

NCT06543758 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-11-19

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Principal Investigators

  • Na Young Kim, MD, PhD · Severance Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2025-07-31
Completion
2026-07-31

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 NCT06543758 on ClinicalTrials.gov