Wearable Lower Extremity Exoskeleton to Promote Walking in Persons Wit

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

CompletedNot a drug-phase studyMS (type not specified)NCT02519244

What it found

Results posted, not judged

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

  • Ekso® (Wearable lower limb exoskeleton)

Results by group

Speed in the Timed 25 Feet Walk Test at Self-selected Speed (Without Exoskeleton)

baseline

GroupValueIntervalNumber analysed
Robot-assisted Rehabilitation0.35 meters per second (m/s)0.18 (Standard Deviation)10

Speed in the Timed 25 Feet Walk Test at Self-selected Speed (Without Exoskeleton)

3 weeks

GroupValueIntervalNumber analysed
Robot-assisted Rehabilitation0.46 meters per second (m/s)0.24 (Standard Deviation)8

Speed in the Timed 25 Feet Walk Test at Self-selected Speed (With Exoskeleton)

3 weeks

GroupValueIntervalNumber analysed
Robot-assisted Rehabilitation0.30 meters per second (m/s)0.09 (Standard Deviation)8

Speed in the Timed 25 Feet Walk Test at Fast Speed (Without Exoskeleton)

baseline

GroupValueIntervalNumber analysed
Robot-assisted Rehabilitation0.51 meters per second (m/s)0.24 (Standard Deviation)9

Speed in the Timed 25 Feet Walk Test at Fast Speed (Without Exoskeleton)

3 weeks

GroupValueIntervalNumber analysed
Robot-assisted Rehabilitation0.61 meters per second (m/s)0.32 (Standard Deviation)8

Speed in the Timed 25 Feet Walk Test at Fast Speed (With Exoskeleton)

3 weeks

GroupValueIntervalNumber analysed
Robot-assisted Rehabilitation0.33 meters per second (m/s)0.11 (Standard Deviation)8

Distance Walked During the Six-minute Walk Test (Without Exoskeleton)

baseline

GroupValueIntervalNumber analysed
Robot-assisted Rehabilitation121.15 meters64.66 (Standard Deviation)10

Distance Walked During the Six-minute Walk Test (Without Exoskeleton)

3 weeks

GroupValueIntervalNumber analysed
Robot-assisted Rehabilitation138.90 meters66.89 (Standard Deviation)8

Distance Walked During the Six-minute Walk Test (With Exoskeleton)

3 weeks

GroupValueIntervalNumber analysed
Robot-assisted Rehabilitation108.09 meters26.26 (Standard Deviation)8

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)

baseline

GroupValueIntervalNumber analysed
Robot-assisted Rehabilitation2.83 ml/min/Kg1.12 (Standard Deviation)10

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)

3 weeks

GroupValueIntervalNumber analysed
Robot-assisted Rehabilitation5.72 ml/min/Kg1.06 (Standard Deviation)8

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)

3 weeks

GroupValueIntervalNumber analysed
Robot-assisted Rehabilitation6.33 ml/min/Kg1.32 (Standard Deviation)8

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)

baseline

GroupValueIntervalNumber analysed
Robot-assisted Rehabilitation3.6 ml/min/Kg1.31 (Standard Deviation)8

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)

3 weeks

GroupValueIntervalNumber analysed
Robot-assisted Rehabilitation6.87 ml/min/Kg1.44 (Standard Deviation)8

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)

3 weeks

GroupValueIntervalNumber analysed
Robot-assisted Rehabilitation7.59 ml/min/Kg1.32 (Standard Deviation)8

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)

baseline

GroupValueIntervalNumber analysed
Robot-assisted Rehabilitation5.76 ml/min/Kg1.25 (Standard Deviation)10

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)

3 weeks

GroupValueIntervalNumber analysed
Robot-assisted Rehabilitation10.20 ml/min/Kg0.9 (Standard Deviation)8

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)

3 weeks

GroupValueIntervalNumber analysed
Robot-assisted Rehabilitation7.77 ml/min/Kg1.12 (Standard Deviation)8

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Robot-assisted Rehabilitation100 (0.0%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Speed in the Timed 25 Feet Walk Test at Self-selected Speed (Without Exoskeleton)

    baseline

    Disability progressionWalking and mobilityPhysical functionSafety

  • Speed in the Timed 25 Feet Walk Test at Self-selected Speed (Without Exoskeleton)

    3 weeks

    Disability progressionWalking and mobilityPhysical functionSafety

  • Speed in the Timed 25 Feet Walk Test at Self-selected Speed (With Exoskeleton)

    3 weeks

    Disability progressionWalking and mobilityPhysical functionSafety

  • Speed in the Timed 25 Feet Walk Test at Fast Speed (Without Exoskeleton)

    baseline

    Disability progressionWalking and mobilityPhysical functionSafety

  • Speed in the Timed 25 Feet Walk Test at Fast Speed (Without Exoskeleton)

    3 weeks

    Disability progressionWalking and mobilityPhysical functionSafety

  • Speed in the Timed 25 Feet Walk Test at Fast Speed (With Exoskeleton)

    3 weeks

    Disability progressionWalking and mobilityPhysical functionSafety

  • Distance Walked During the Six-minute Walk Test (Without Exoskeleton)

    baseline

    Walking and mobility

  • Distance Walked During the Six-minute Walk Test (Without Exoskeleton)

    3 weeks

    Walking and mobility

  • Distance Walked During the Six-minute Walk Test (With Exoskeleton)

    3 weeks

    Walking and mobility

  • 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)

    baseline

    Disability progressionWalking and mobilityPhysical function

  • 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)

    3 weeks

    Disability progressionWalking and mobilityPhysical function

  • 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)

    3 weeks

    Disability progressionWalking and mobilityPhysical function

  • 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)

    baseline

    Disability progressionWalking and mobilityPhysical function

  • 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)

    3 weeks

    Disability progressionWalking and mobilityPhysical function

  • 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)

    3 weeks

    Disability progressionWalking and mobilityPhysical function

  • 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)

    baseline

    Walking and mobilityPhysical function

  • 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)

    3 weeks

    Walking and mobilityPhysical function

  • 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)

    3 weeks

    Walking and mobilityPhysical function

Other measures (8)

  • Cognitive Demands as Indicated by Reaction Time in Dual Task Paradigm (Without Exoskeleton)

    3 weeks

    Disability progressionThinking and memoryWalking and mobilityPain

  • Cognitive Demands as Indicated by Reaction Time in Dual Task Paradigm (With Exoskeleton)

    3 weeks

    Disability progressionThinking and memoryWalking and mobilityPain

  • Amount of Time Taken to Complete the Time Up and Go Test (Without Exoskeleton)

    baseline

    Walking and mobility

  • Amount of Time Taken to Complete the Time Up and Go Test (Without Exoskeleton)

    3 weeks

    Walking and mobility

  • Quality of Life as Assessed by the Multiple Sclerosis Quality of Life-54 (MSQOL-54) Questionnaire - Physical Health Composite Score

    baseline

    Quality of life (reported by participants)

  • Quality of Life as Assessed by the Multiple Sclerosis Quality of Life-54 (MSQOL-54) Questionnaire - Physical Health Composite Score

    3 weeks

    Quality of life (reported by participants)

  • Quality of Life as Assessed by the Multiple Sclerosis Quality of Life-54 (MSQOL-54) Questionnaire - Mental Health Composite Score

    baseline

    Quality of life (reported by participants)

  • Quality of Life as Assessed by the Multiple Sclerosis Quality of Life-54 (MSQOL-54) Questionnaire - Mental Health Composite Score

    3 weeks

    Quality of life (reported by participants)

Who could take part

MS (type not specified) · 18 to 65

Show the full criteria

Inclusion 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

Exclusion criteria

Not separately supplied in the registry.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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

Papers

Loading reviews and guidelines…

History

    1. Started

      May 2015

    2. Main results due

      Feb 2017

    3. Finished

      Feb 2017

    4. Results posted

      May 2019

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