Effectiveness and Safety of At-home Gait Rehabilitation Using Wearable Exoskeletal Robot
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19-79
SponsorYonsei University
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
individuals with severe joint contractures or osteoporosis, or untreated fractures that contraindicate weight-bearing on the lower limbs.
individuals with skin conditions or open wounds that prevent device usage.
individuals with significant differences in leg length.
individuals with severe deformities or joint contractures in the lower limbs.
Trial design
Treatments tested in this trial
- Wearable exoskeletal robot
Treatment groups
16 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov