N/A N=10 Supportive Care

Wearable Lower Extremity Exoskeleton to Promote Walking in Persons With Multiple Sclerosis

Multiple Sclerosis

Bottom Line

View on ClinicalTrials.gov: NCT02519244 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2019

Primary outcome: Primary: Speed in the Timed 25 Feet Walk Test at Self-selected Speed (Without Exoskeleton) — 0.35 meters per second (m/s)

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Ekso® (Wearable lower limb exoskeleton) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The University of Texas Health Science Center, Houston
Primary completion: Feb 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Speed in the Timed 25 Feet Walk Test at Self-selected Speed (Without Exoskeleton)	0.46	—
PRIMARY Speed in the Timed 25 Feet Walk Test at Self-selected Speed (Without Exoskeleton)	0.46	—
PRIMARY Speed in the Timed 25 Feet Walk Test at Self-selected Speed (With Exoskeleton)	0.30	—
PRIMARY Speed in the Timed 25 Feet Walk Test at Fast Speed (Without Exoskeleton)	0.61	—
PRIMARY Speed in the Timed 25 Feet Walk Test at Fast Speed (Without Exoskeleton)	0.61	—
PRIMARY Speed in the Timed 25 Feet Walk Test at Fast Speed (With Exoskeleton)	0.33	—
PRIMARY Distance Walked During the Six-minute Walk Test (Without Exoskeleton)	138.90	—
PRIMARY Distance Walked During the Six-minute Walk Test (Without Exoskeleton)	138.90	—
PRIMARY Distance Walked During the Six-minute Walk Test (With Exoskeleton)	108.09	—
PRIMARY Physical Demands as Assessed by Energy Expenditure (Which is Indicated by VO2-max as Measured by the Cosmed K4b2) During the Timed 25 Feet Walk Test at Self-selected Speed (Without Exoskeleton)	5.72	—
PRIMARY Physical Demands as Assessed by Energy Expenditure (Which is Indicated by VO2-max as Measured by the Cosmed K4b2) During the Timed 25 Feet Walk Test at Self-selected Speed (Without Exoskeleton)	5.72	—
PRIMARY Physical Demands as Assessed by Energy Expenditure (Which is Indicated by VO2-max as Measured by the Cosmed K4b2) During the Timed 25 Feet Walk Test at Self-selected Speed (With Exoskeleton)	6.33	—
PRIMARY Physical Demands as Assessed by Energy Expenditure (Which is Indicated by VO2-max as Measured by the Cosmed K4b2) During the Timed 25 Feet Walk Test at Fast Speed (Without Exoskeleton)	6.87	—
PRIMARY Physical Demands as Assessed by Energy Expenditure (Which is Indicated by VO2-max as Measured by the Cosmed K4b2) During the Timed 25 Feet Walk Test at Fast Speed (Without Exoskeleton)	6.87	—
PRIMARY Physical Demands as Assessed by Energy Expenditure (Which is Indicated by VO2-max as Measured by the Cosmed K4b2) During the Timed 25 Feet Walk Test at Fast Speed (With Exoskeleton)	7.59	—
PRIMARY Physical Demands as Assessed by Energy Expenditure (Which is Indicated by VO2-max as Measured by the Cosmed K4b2) During the Six-Minute Walk Test (Without Exoskeleton)	10.20	—
PRIMARY Physical Demands as Assessed by Energy Expenditure (Which is Indicated by VO2-max as Measured by the Cosmed K4b2) During the Six-Minute Walk Test (Without Exoskeleton)	10.20	—
PRIMARY Physical Demands as Assessed by Energy Expenditure (Which is Indicated by VO2-max as Measured by the Cosmed K4b2) During the Six-Minute Walk Test (With Exoskeleton)	7.77	—
SECONDARY Cognitive Demands as Indicated by Reaction Time in Dual Task Paradigm (Without Exoskeleton)	0.51	—
SECONDARY Cognitive Demands as Indicated by Reaction Time in Dual Task Paradigm (With Exoskeleton)	0.67	—
SECONDARY Amount of Time Taken to Complete the Time Up and Go Test (Without Exoskeleton)	28.64	—
SECONDARY Amount of Time Taken to Complete the Time Up and Go Test (Without Exoskeleton)	28.64	—
SECONDARY Quality of Life as Assessed by the Multiple Sclerosis Quality of Life-54 (MSQOL-54) Questionnaire - Physical Health Composite Score	57.6	—
SECONDARY Quality of Life as Assessed by the Multiple Sclerosis Quality of Life-54 (MSQOL-54) Questionnaire - Physical Health Composite Score	57.6	—
SECONDARY Quality of Life as Assessed by the Multiple Sclerosis Quality of Life-54 (MSQOL-54) Questionnaire - Mental Health Composite Score	78.8	—
SECONDARY Quality of Life as Assessed by the Multiple Sclerosis Quality of Life-54 (MSQOL-54) Questionnaire - Mental Health Composite Score	78.8	—

Summary

The purpose of this study is to investigate whether a wearable robotic exoskeleton can help people with multiple sclerosis (MS) to walk again.

Eligibility Criteria

Subjects will be enrolled if they meet the following inclusion criteria:

Age 18 years or older
Ambulatory with assistive devices (Ambulation status will be determined by the EDSS score)
With an Expanded Disability Status Scale (EDSS) score between 6 and 7.5 inclusive
Height and weight are between 160 and 188 cm (5'2'' to 6'2''), and less than 100 kg (220 lb), respectively (per exoskeleton manufacturer)
Able to follow simple 3 step commends
Able to understand the study procedure and consent form

Subjects will be excluded if they have any of the following exclusion criteria:

History of severe neurologic injuries other than MS (Spinal Cord Injury, Cerebral Palsy, Amyotrophic Lateral Sclerosis, Traumatic Brain Injury, Cerebral Vascular Accident, etc.)
Severe comorbidities:
active infections
heart, lung, or circulatory conditions
pressure ulcers
Documented severe osteoporosis affecting the hip and spine
Severe spasticity in the lower extremities (Modified Ashworth ≥ 3) or uncontrolled clonus
Unhealed limb or pelvic fractures
Skin issues that would prevent wearing the device
Range of motion restrictions that would prevent subject from achieving a normal, reciprocal gait pattern, or would restrict a subject from completing normal sit to stand or stand to sit transitions.
Upper extremity strength deficits that limit ability to balance with a front rolling walker or crutches.
Heterotopic ossification that resists functional range of motion in lower extremities
Contractures (>15 degrees at the hips or >20 degrees at the knees)
Psychiatric or cognitive comorbidities resulting in motor planning or impulsivity concerns
Colostomy
Have received any physical therapy intervention within 3 months prior to enrolment in the study
Non-English speaking

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02519244). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.