Clinical Effectiveness of Robot-assisted Gait Training in Patients With Lower Limb Burns Accompanied by Fractures: Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Enrollment
- 5
- Locations
- 1
Study Overview
Brief 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.
Detailed Description
Background : 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.
Material and Methods
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. To evaluate clinical efficacy, functional ambulation category (FAC), muscle strength (manual muscle test, MMT), active range of motion (AROM) of the lower limbs, 6-minute walking test (6 MWT), pain score, gait kinematics, and spatiotemporal gait parameters will be measured before and after 8 weeks training.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Outcome measurements and data analyses were conducted by trained, blinded assessors who were not involved in the training.
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.