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Tests treatment safety and results for Stroke
Official title Evaluate the Effectiveness and Safety of At-Home Rehabilitation Gait Training Using a Hip-assisted Wearable Robot in Stroke Patients
ClinicalTrials.gov ID: NCT07716475
What this study is testing
- What it's testing
- The goal of this clinical trial is to learn whether a wearable monitoring system can help adults who have had a stroke get more out of a home exercise program. The system tracks how participants walk and move, then gives them feedback.
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 80
You may be able to join if
- Adults aged 19 years or older and under 80 years
- Persons diagnosed with cerebral infarction or intracerebral hemorrhage confirmed by magnetic resonance imaging or computed tomography
- Persons for whom at least 1 month has elapsed since the diagnosis of stroke
- Persons showing a spastic hemiplegic gait pattern due to stroke
- Patients with a Functional Ambulatory Category score below 4
You likely can't join if
- Persons with contraindications to lower-extremity weight bearing, such as severe lower-extremity joint contracture or an untreated fracture
- Persons for whom wearing the device is difficult due to skin disease or open wounds
- Persons with a severe difference in the length of the two lower extremities
- Persons with severe deformity or joint contracture in the lower extremities
- Persons unable to maintain a sitting posture or a standing posture on their own
- Persons with severe lower-extremity spasticity (Modified Ashworth Scale (MAS) grade 2 or higher)
See the full eligibility criteria
- Adults aged 19 years or older and under 80 years
- Persons diagnosed with cerebral infarction or intracerebral hemorrhage confirmed by magnetic resonance imaging or computed tomography
- Persons for whom at least 1 month has elapsed since the diagnosis of stroke
- Persons showing a spastic hemiplegic gait pattern due to stroke
- Patients with a Functional Ambulatory Category score below 4
- Persons who can sit without assistance at the edge of a bed and can stand for 10 seconds with or without assistance
- Persons with sufficient cognitive ability to follow simple instructions and understand the content and purpose of the study (Mini-Mental State Examination score \>= 20)
- Persons with contraindications to lower-extremity weight bearing, such as severe lower-extremity joint contracture or an untreated fracture
- Persons for whom wearing the device is difficult due to skin disease or open wounds
- Persons with a severe difference in the length of the two lower extremities
- Persons with severe deformity or joint contracture in the lower extremities
- Persons unable to maintain a sitting posture or a standing posture on their own
- Persons with severe lower-extremity spasticity (Modified Ashworth Scale (MAS) grade 2 or higher)
- Persons who cannot cooperate with gait therapy using the robot-assisted orthopedic exercise device due to severe cognitive decline (Mini-Mental State Examination score \< 20), delirium, or severe language function...
- Persons who cannot maintain prolonged standing or walking due to underlying conditions such as orthostatic hypotension or reduced cardiopulmonary function
- Persons with other concomitant conditions affecting gait, such as peripheral neuropathy or parkinsonism due to alcoholism or severe diabetes
- Pregnant women or patients with the possibility of pregnancy
- Persons currently participating in another clinical trial
- Persons at high risk in the event of a fall or bleeding due to a coagulation disorder or the like
- Persons with a height less than 140 cm or greater than 190 cm
- Persons for whom wearing the robot is not possible
- Persons with clinically significant findings that, in the medical judgment of the principal investigator or a sub-investigator, are considered inappropriate for this study other than the above
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 80 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.