Clinical Effectiveness of Robot-assisted Gait Training in Patients With Lower Limb Burns Accompan… (NCT07578753) | Clinical Trial Compass
By InvitationNot Applicable
Clinical Effectiveness of Robot-assisted Gait Training in Patients With Lower Limb Burns Accompanied by Fractures: Pilot Study
South Korea5 participantsStarted 2024-04-15
Plain-language summary
Gait dysfunction, common in patients with lower limb burns accompanied by fractures, requires acute rehabilitation. This study investigated the clinical effects of robot-assisted gait training (RAGT) on gait function in patients with lower limb burns accompanied by fractures.
In this preliminary study, RAGT will be conducted using an end-effector-type gait-training robot. Participants will receive 60 min of gait training daily (30 min of conventional gait training and 30 min of RAGT) for 8 weeks. We plan to conduct clinical evaluations related to gait function of the participants included in the preliminary study before training and after 8 weeks of training.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* aged 19 years or older
* admitted to the Department of Rehabilitation Medicine after the wound had epithelialized following wound treatment via skin grafting or aseptic dressing procedures
* underwent fixation or brace treatment after a lower limb fracture was diagnosed via imaging at the time of injury
* sufficient cognitive function to follow the therapist's instructions during training
* a functional ambulatory category (FAC) of 1 or higher and 3 or lower.
Exclusion Criteria:
* unable to bear weight owing to fracture union failure or complications such as osteomyelitis
* severe pain rendering the patient unable to wear the robotic device
* scars that may bleed or become infected when wearing the robotic device
* a history of lower limb weakness or reduced gait ability due to other causes prior to injury
* lower limb sensory disturbances caused by peripheral neuropathic diseases such as diabetes
* height less than 120 cm or body mass more than 120 kg
* withdrawal of consent.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.