Clinical trial NCT02519244: Wearable Lower Extremity Exoskeleton to Promote Walking in Persons With Multiple Sclerosis
Official title: Wearable Lower Extremity Exoskeleton to Promote Walking in Persons With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Ambulation
Rehabilitation
Wearable Robotic Devices
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
name: Texas Woman's University
First posted: 2015-08-10
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: Loss of the ability to walk is one of the significant problems in persons with multiple sclerosis (MS). This limitation prevents the person from having an active and meaningful life at home and in the community. Also, more energy is needed to walk, which can cause fatigue and further leads to a non-active life style and poor quality of life. Unfortunately, walking training is often not available for this population because of the severity and progress of the disease; therefore, a new strategy is needed to help people with MS to walk again. A new technology, the wearable robotic exoskeleton, has been developed to help persons with spinal cord injuries stand up and walk. The robotic legs are powered by batteries and controlled by motors. This study will investigate the use of a wearable robotic exoskeleton to help persons with MS to walk. Participants will receive trainings (5 days per week for 3 weeks) to walk with the robotic exoskeleton (EKSO, EKSO Bionics, Richmond, CA). During the training, a physical therapist will teach the participant how to maintain balance, sit to stand, stand to sit, and walk with the wearable robotic exoskeleton. The hypothesis is that persons with MS will be able to use a robotic exoskeleton to walk better and with less energy costs.

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

Primary outcomes:
measure: Speed in the Timed 25 Feet Walk Test at Self-selected Speed (Without Exoskeleton)
timeFrame: baseline
measure: Speed in the Timed 25 Feet Walk Test at Self-selected Speed (Without Exoskeleton)
timeFrame: 3 weeks
measure: Speed in the Timed 25 Feet Walk Test at Self-selected Speed (With Exoskeleton)
timeFrame: 3 weeks
measure: Speed in the Timed 25 Feet Walk Test at Fast Speed (Without Exoskeleton)
timeFrame: baseline
measure: Speed in the Timed 25 Feet Walk Test at Fast Speed (Without Exoskeleton)
timeFrame: 3 weeks
measure: Speed in the Timed 25 Feet Walk Test at Fast Speed (With Exoskeleton)
timeFrame: 3 weeks
measure: Distance Walked During the Six-minute Walk Test (Without Exoskeleton)
timeFrame: baseline
measure: Distance Walked During the Six-minute Walk Test (Without Exoskeleton)
timeFrame: 3 weeks
measure: Distance Walked During the Six-minute Walk Test (With Exoskeleton)
timeFrame: 3 weeks
measure: 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)
timeFrame: baseline
measure: 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)
timeFrame: 3 weeks
measure: 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)
timeFrame: 3 weeks
measure: 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)
timeFrame: baseline
measure: 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)
timeFrame: 3 weeks
measure: 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)
timeFrame: 3 weeks
measure: 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)
timeFrame: baseline
measure: 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)
timeFrame: 3 weeks
measure: 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)
timeFrame: 3 weeks
Secondary outcomes:
measure: Cognitive Demands as Indicated by Reaction Time in Dual Task Paradigm (Without Exoskeleton)
timeFrame: 3 weeks
measure: Cognitive Demands as Indicated by Reaction Time in Dual Task Paradigm (With Exoskeleton)
timeFrame: 3 weeks
measure: Amount of Time Taken to Complete the Time Up and Go Test (Without Exoskeleton)
timeFrame: baseline
measure: Amount of Time Taken to Complete the Time Up and Go Test (Without Exoskeleton)
timeFrame: 3 weeks
measure: Quality of Life as Assessed by the Multiple Sclerosis Quality of Life-54 (MSQOL-54) Questionnaire - Physical Health Composite Score
timeFrame: baseline
measure: Quality of Life as Assessed by the Multiple Sclerosis Quality of Life-54 (MSQOL-54) Questionnaire - Physical Health Composite Score
timeFrame: 3 weeks
measure: Quality of Life as Assessed by the Multiple Sclerosis Quality of Life-54 (MSQOL-54) Questionnaire - Mental Health Composite Score
timeFrame: baseline
measure: Quality of Life as Assessed by the Multiple Sclerosis Quality of Life-54 (MSQOL-54) Questionnaire - Mental Health Composite Score
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: TIRR Memorial Hermann
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Shuo-Hsiu Chang, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Afzal T, Tseng SC, Lincoln JA, Kern M, Francisco GE, Chang SH. Exoskeleton-assisted Gait Training in Persons With Multiple Sclerosis: A Single-Group Pilot Study. Arch Phys Med Rehabil. 2020 Apr;101(4):599-606. doi: 10.1016/j.apmr.2019.10.192. Epub 2019 Dec 7.