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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Wearable exoskeletal robot
DeviceParticipants 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.
Treatment groups
16 Participants
are divided into 1 treatment groupGroup A: Wearable exoskeletal robot groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
10MWT (10 meter walk test)
A simple and effective clinical evaluation method used to measure the walking speed of participants, useful for assessing functional recovery and changes in gait ability. The measurement method involves timing how long it takes to walk 10 meters, then dividing 10 by the time taken to record the walking speed (m/s).
Time frame
This session will be performed at baseline and after the intervention. A baseline assessment will be conducted within 2 days before the robotic-assisted gait training, and an end-point assessment will be conducted within 2 days after the gait training.Secondary outcomes
1
Health-related quality of life measurement (36-item Short Form Survey Instrument, SF-36)
A self-reported survey consisting of 36 items used to assess participants' overall health-related quality of life. The evaluation tool measures satisfaction with overall health, with scores ranging from 0 to 100.
Time frame
This session will be performed at baseline and after the intervention. A baseline assessment will be conducted within 2 days before the robotic-assisted gait training, and an end-point assessment will be conducted within 2 days after the gait training.2
Beck depression inventory (BDI)
An evaluation tool designed based on clinical depressive symptoms. It consists of 21 self-reported items where patients check and record their scores in areas such as affective cognition and motivation. Scores range from 0 to 63.
Time frame
This session will be performed at baseline and after the intervention. A baseline assessment will be conducted within 2 days before the robotic-assisted gait training, and an end-point assessment will be conducted within 2 days after the gait training.3
Body composition analysis
This is a test performed to check the subject's limb muscle mass, and the test method is as follows. * Perform body composition analysis17 based on bioimpedance analysis. * To ensure accurate measurement, the test subject is instructed to empty his/her bladder before the test and not to consume caffeinated beverages, eat, drink, or perform strenuous exercise for one hour prior to the test. * To correct for muscle mass differences due to height, use the calculated value of limb muscle mass (Appendicular skeletal mass) divided by the square of the height.
Time frame
This session will be performed at baseline and after the intervention. A baseline assessment will be conducted within 2 days before the robotic-assisted gait training, and an end-point assessment will be conducted within 2 days after the gait training.4
Spatiotemporal parameters of walking
Spatiotemporal parametric data of gait collected while the subject is performing a home-based activity wearing an insole gait analyzer, recording total steps, steps per minute, gait speed (km/h), distance walked (m), stride length (m), and swing phase rate (%).
Time frame
This session will be performed at baseline and after the intervention. A baseline assessment will be conducted within 2 days before the robotic-assisted gait training, and an end-point assessment will be conducted within 2 days after the gait training.Sponsors and contacts
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Source ClinicalTrials.gov