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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.

Spinal cord
July 1, 2020
Xiao-Na Xiang et al. (7 authors)
Journal ArticleObservational StudyHuman StudyClinical
Study Details

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

Extracted Claims (9)
InterventionDirectionEndpointPopulationDosageImpactClaim #
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
Abstract

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.

Medical Subject Headings (MeSH)
AdolescentAdultAgedExercise TherapyExoskeleton DeviceFeasibility StudiesFemaleHumansMaleMiddle AgedNeurological RehabilitationOutcome and Process Assessment, Health CareParaplegiaProgram EvaluationSpinal Cord InjuriesWalkingYoung Adult
Study Links
Quality Scores
Safety76
Efficacy82/10
Quality68/10
Citation Metrics
Total Citations22
Citations/Year4.4
Relative Citation Ratio2.68
NIH Percentile82.5%
Research Impact Scores
APT Score0.75
Weight Score2.22
Normalized Score0.77
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