The safety and feasibility of a new rehabilitation robotic exoskeleton for assisting individuals with lower extremity motor complete lesions following spinal cord injury (SCI): an observational study.
Study Goal
The researchers aimed to evaluate the safety and feasibility of a new robotic exoskeleton for assisting walking in individuals with motor-complete spinal cord injuries.
Results Summary
The study found improvements in walking distance (6MWT) and speed (10MWT), as well as enhanced Hoffer walking ability grade, SCIM, and WISCI II scores after 2 weeks of exoskeletal-assisted walking. No improvement in lower extremity motor score was observed, and adverse event rates were 21% (non-serious) and 4% (serious).
Population
Individuals aged 15-75 with motor-complete spinal cord injuries (T6-L1).
Effective Dosage
30 minutes/day, 5 days/week
Duration
2 weeks
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
exoskeletal-assisted walking (EAW) programme | increase | distance walked during the 6-min walking test (6MWT) | individuals with lower extremity motor complete lesions following spinal cord injury (SCI) | 13.0 ± 5.3 m (week 1) | increased | #1 |
exoskeletal-assisted walking (EAW) programme | increase | distance walked during the 6-min walking test (6MWT) | individuals with lower extremity motor complete lesions following spinal cord injury (SCI) | 16.2 ± 5.3 m (week 2) | increased | #2 |
exoskeletal-assisted walking (EAW) programme | increase | walking speed during the 10-m walking test (10MWT) | individuals with lower extremity motor complete lesions following spinal cord injury (SCI) | from 0.039 ± 0.016 to 0.045 ± 0.016 m/s | increased | #3 |
exoskeletal-assisted walking (EAW) programme | increase | Hoffer walking ability grade | individuals with lower extremity motor complete lesions following spinal cord injury (SCI) | - | changed | #4 |
exoskeletal-assisted walking (EAW) programme | increase | Spinal Cord Independence Measure (SCIM) | individuals with lower extremity motor complete lesions following spinal cord injury (SCI) | - | changed | #5 |
exoskeletal-assisted walking (EAW) programme | increase | Walking Index for SCI II (WISCI II) | individuals with lower extremity motor complete lesions following spinal cord injury (SCI) | - | changed | #6 |
exoskeletal-assisted walking (EAW) programme | no change | lower extremity motor score (LEMS) | individuals with lower extremity motor complete lesions following spinal cord injury (SCI) | - | no improvement | #7 |
exoskeletal-assisted walking (EAW) programme with the new robotic exoskeleton | increase | mobility | individuals with SCI | - | provided potential meaningful improvements | #8 |
exoskeletal-assisted walking (EAW) programme with the new robotic exoskeleton | decrease | adverse events | individuals with SCI | 21% adverse events, 4% serious adverse events | had few | #9 |
STUDY DESIGN: A pre-post observational study. OBJECTIVES: To evaluate the safety and feasibility of a new rehabilitation robotic device for assisting individuals with lower extremity motor complete lesions following spinal cord injury (SCI). SETTING: Three hospitals in Sichuan Province, China. METHODS: Individuals aged 15-75 years with an SCI between vertebrae six (T6) and lumbar 1 (L1) and complete motor paralysis participated in an exoskeletal-assisted walking (EAW) programme (2 weeks, 5 days/week, 30 min/day). Data were collected pre-, mid- (week 1) and post-intervention (week 2). RESULTS: Twenty-eight individuals (mean age = 41.3, 71% males) participated in the EAW programme. The distance walked during the 6-min walking test (6MWT) increased relative to that at baseline, during week 1 (13.0 ± 5.3 m) and week 2 (16.2 ± 5.3 m) when wearing the exoskeleton. The walking speed during the 10-m walking test (10MWT) increased from 0.039 ± 0.016 to 0.045 ± 0.016 m/s. The Hoffer walking ability grade, the Spinal Cord Independence Measure (SCIM), and the Walking Index for SCI II (WISCI II) changed after 2 weeks of EAW. No improvement in lower extremity motor score (LEMS) was observed. The rates of adverse events and serious adverse events were 21% and 4%, respectively. CONCLUSIONS: The EAW programme with the new robotic exoskeleton provided potential meaningful improvements in mobility for individuals with SCI and had few adverse events.