Actively Recruiting
Effectiveness and Safety of At-home Gait Rehabilitation Using Wearable Exoskeletal Robot
Led by Yonsei University · Updated on 2024-11-19
16
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Effectiveness and Safety of At-home Gait Rehabilitation Using Wearable Exoskeletal Robot
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 19 to 79 years
- Diagnosed with cerebral infarction or intracerebral hemorrhage confirmed by MRI or CT
- At least one month has passed since stroke diagnosis
- Exhibit spastic hemiplegic gait pattern due to stroke
- Functional Ambulatory Category score less than 4
- Able to sit on the edge of a bed without assistance and stand for 10 seconds with or without assistance
- Mini-Mental State Examination score of 20 or higher indicating sufficient cognitive ability
You will not qualify if you...
- Severe joint contractures, osteoporosis, or untreated fractures preventing weight-bearing on lower limbs
- Skin conditions or open wounds preventing device use
- Significant leg length differences
- Severe deformities or joint contractures in lower limbs
- High fracture risk due to conditions like osteoporosis
- Unable to maintain sitting or standing positions independently
- Severe lower limb spasticity (Modified Ashworth Scale grade 2 or higher)
- Severe cognitive impairment (MMSE score less than 20), delirium, or severe language impairment
- Unable to maintain prolonged standing or walking due to orthostatic hypotension or cardiopulmonary impairment
- Conditions affecting gait such as peripheral neuropathy, Parkinsonism, alcohol dependence, or severe diabetes
- Pregnant or could become pregnant
- Participation in other clinical trials
- High risk of falls or bleeding due to coagulopathies
- Height less than 140 cm, taller than 190 cm, or weight over 80 kg
- Other clinical findings deemed inappropriate by the principal investigator or study coordinator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Yongin Severance Hospital
Yongin-si, Gyeonggi-do, South Korea, 16995
Actively Recruiting
Research Team
N
Na Young Kim, MD, PhD
CONTACT
S
Seung Ick Choi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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