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Tests treatment safety and results for Stroke
Official title Effectiveness and Safety of At-home Gait Rehabilitation Using Wearable Exoskeletal Robot
ClinicalTrials.gov ID: NCT06543758
What this study is testing
- What it's testing
- 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?
- Phase 4: studies an already-approved treatment
- Time commitment: about 4 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 79
You may be able to join if
- 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.
- patients with a Functional Ambulatory Category score of less than 4.
You likely can't join if
- 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.
- individuals at high risk of fractures due to conditions like osteoporosis.
- individuals unable to maintain a sitting or standing position independently.
See the full eligibility criteria
- 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.
- patients with a Functional Ambulatory Category score of less than 4.
- individuals who can sit on the edge of a bed without assistance and stand for 10 seconds with or without assistance.
- individuals with sufficient cognitive ability to follow simple instructions and understand the study's content and purpose (Mini-Mental State Examination score \>= 20)
- 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.
- individuals at high risk of fractures due to conditions like osteoporosis.
- individuals unable to maintain a sitting or standing position independently.
- individuals with severe lower limb spasticity (Modified Ashworth Scale grade 2 or higher).
- individuals with severe cognitive impairment (Mini-Mental State Examination score \< 20), delirium, or severe language impairment that hinders cooperation with wearable exoskeletal robot gait training.
- individuals unable to maintain prolonged standing or walking due to conditions like orthostatic hypotension or cardiopulmonary impairment.
- individuals with conditions affecting gait, such as peripheral neuropathy, Parkinsonism, or those with alcohol dependence or severe diabetes.
- pregnant women or those who could become pregnant.
- individuals participating in other clinical trials.
- individuals at high risk of falls or bleeding due to conditions like coagulopathies.
- individuals shorter than 140 cm, taller than 190 cm, or weighing over 80 kg.
- individuals with other clinical findings deemed inappropriate for the study by the principal investigator or study coordinator.
The study team makes the final eligibility decision.
Where it's taking place
- Yongin-si, Gyeonggi-do, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Yongin-si, Gyeonggi-do, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.