Wearable hip-robot training to improve walking after major lower-leg burns

The Effect of Mobile Robot Assisted Gait Training on Gait Performance in Chronic Patients With Impaired Gait Function After Burn Injury : Pilot Study

This 12-week program will try using a wearable hip-assist robot during daily physiotherapy to help adults who still have walking problems six months after large lower-extremity burns walk better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 19 Years to 65 Years
• Sex: All
• Sponsor: Hangang Sacred Heart Hospital (Academic / other)
• Locations: 1 site (Seoul)
• Trial ID: NCT07277166 on ClinicalTrials.gov

What this trial studies

This interventional program enrolls adults with chronic gait impairment following extensive lower-extremity burns or split-thickness skin grafting and a Functional Ambulation Category (FAC) score of 3 or higher. Participants receive one-to-one physiotherapy with a wearable hip-centered robotic device for 1 hour a day, five days a week, over 12 weeks. Outcomes are measured before and immediately after the training using FAC, the 6-Minute Walk Test, a visual analogue pain scale, spatiotemporal gait parameters (speed, cadence, step length), and sagittal joint kinematics for hip, knee, and ankle. Key exclusions include fourth-degree burns, severe communication impairments, cardiac/circulatory conditions, extreme height or BMI preventing robot fit, and high fall risk.

Who should consider this trial

Good fit: Adults over 18 with persistent gait dysfunction at least six months after split-thickness grafting or burns covering more than half of the lower extremities, with FAC score ≥3 and who fit the wearable robot (height and BMI limits) are ideal candidates.

Not a fit: Patients with fourth-degree burns affecting deep tissues, severe cognitive or communication disorders, cardiac/circulatory conditions, extreme height or obesity that prevent robot use, or a recent high fall risk are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could improve walking speed, endurance, posture, and independence for people with long-lasting gait problems after major lower-extremity burns.

How similar studies have performed: Wearable hip-assist robots have shown improved energy efficiency and posture in other walking populations, but their specific use for post-burn gait dysfunction is relatively novel with limited direct evidence.

Eligibility criteria

Inclusion Criteria:

* chronic patients who underwent split-thickness skin grafting or burns of more than 50% of the lower extremities and still had impaired gait dysfunction 6 months later. -aged over 18 years
* had a Functional Ambulation Category (FAC) score of 3 or higher

Exclusion Criteria:

* fourth-degree burns (involving muscles, tendons, and bone injuries)
* severe communication disorders because of intellectual impairment and psychological problems
* Patients with body types that prevent them form wearing the robot, such as a height of 4.59 feet (140cm) or 5.91 feet (185cm) or more, or severe obesity with a BMI of 35 or more.
* Patients with heart and circulatory conditions that may affect gait training.
* Patients at a high risk of falling during gait training, owing to severe dizziness and having experienced a fall within the preceeding 2 month.

Where this trial is running

Seoul

• Hangang sacred heart hodpital — Seoul, South Korea (Recruiting)

Study contacts

• Study coordinator: So Young Joo

Conditions Burns; Gait Dysfunction; Robot Training; BURNS, Gait dysfunction, Wearable robot, Robot training