Burn, Fracture, Robot Assisted Gait Training
Conditions
Keywords
Burn, Fracture, Robot assisted gait training
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.
Interventions
All participants underwent 60 min of daily gait training consisting of 30 min of conventional physical therapy in the morning and 30 min of RAGT in the afternoon. All participants underwent 40 gait training sessions over 8 weeks, five times per week. Conventional physical training consisted of ROM exercises and strength training for the lower limbs and ground gait training once weight bearing was possible.
Sponsors
Hangang Sacred Heart Hospital
Study design
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.
Intervention model description
RAGT and conventional gait training were performed by a physical therapist with more than 7 years of experience with patients with burns. Complications in the scar area and worsening of pain were monitored during gait training. All participants underwent 60 min of daily gait training consisting of 30 min of conventional physical therapy in the morning and 30 min of RAGT in the afternoon. All participants underwent 40 gait training sessions over 8 weeks, five times per week. Conventional physical training consisted of ROM exercises and strength training for the lower limbs and ground gait training once weight bearing was possible.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| functional ambulatory category | 8 weeks | Ambulatory ability was assessed using the FAC scale. Participants were rated on a six-point scale based on the level of physical assistance required for walking, regardless of whether an assistive device was used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| manual muscle test, MMT | 8 weeks | . Lower limb muscle strength was assessed using the MMT based on the Medical Research Council scale for muscle strength. |
| active range of motion (AROM) of the lower limbs | 8 weeks | Full AROM of the hip, knee, and ankle joints was measured before and after training. |
| pain score (visual analog scale, VAS) | 8 weeks | A visual analog scale (VAS) was used to rate the degree of subjective pain during gait movement (0 points: no pain, 10 points: unbearable pain). |
| 6-minute walking test (6 MWT) | 8 weeks | The 6 MWT was conducted according to standardized guidelines on a 20-m walking course. Patients were instructed to walk as far as possible within 6 min. |
Countries
South Korea
Outcome results
None listed