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

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ClinicalTrials.gov Identifier: NCT02519244
Recruitment Status : Unknown
Verified June 2016 by Shuo-Hsiu Chang, The University of Texas Health Science Center, Houston.
Recruitment status was:  Recruiting
First Posted : August 10, 2015
Last Update Posted : June 13, 2016
Sponsor:
Collaborators:
National Multiple Sclerosis Society
Texas Woman's University
Information provided by (Responsible Party):
Shuo-Hsiu Chang, The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Device: Ekso® (Wearable lower limb exoskeleton) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Wearable Lower Extremity Exoskeleton to Promote Walking in Persons With Multiple Sclerosis
Study Start Date : May 2015
Estimated Primary Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Robot-assisted rehabilitation
Subjects will participate in individualized locomotion training sessions using wearable lower limb exoskeleton, Ekso®. Each training session will last up to 60 minutes, 5 days per week for 3 weeks, for a total of 15 sessions. During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit.
Device: Ekso® (Wearable lower limb exoskeleton)
The wearable lower limb exoskeleton is a powered, robotic lower limb exoskeleton with actuated hips and knees. A control algorithm has been implemented in this device, which allows for provision of assistance to lower limb segments during movement, dependent on user needs.




Primary Outcome Measures :
  1. Amount of time taken to complete the Time Up and Go Test [ Time Frame: 3 weeks post training ]
    This task will be performed with and without exoskeleton. This task involves subject to stand from the standard chair, walk straight for 3 meters, turn around, walk back to the chair and sit down with shoes and assistive devices if any. A standard chair with arm rests will be place at the start of the testing course. A mark will be placed on the floor at the 3 meter distance.

  2. Amount of time taken to complete the Timed 25 Feet Walk Test [ Time Frame: 3 weeks post training ]
    This task will ask the subject to walk for 25 feet at comfortable pace with and without exoskeleton. Subjects will wear their exercise or walking shoes and are allowed to use assistive device such as cane or walker if necessary. The start and finish line of the 25 feet test course will be marked with tape on the floor. Additional 5 feet at the end of start and finish will be used for subject to turn around. A chair will be provided next to the start area so the subject may rest. During the test, the subject will walk at his/her comfortable pace without losing balance followed by walking at maximal pace. Resting periods will be provided between trials. One trial for each pace will be performed. Trial will be repeated if subject cannot finish the task due to fatigue or loss of balance. A research team member will walk next to the subject for safety. The time to complete the tasks will be recorded.

  3. The distance subject able to complete during the Six-minute walk test [ Time Frame: 3 weeks post training ]
    Subjects will be asked to walk back and forth in a hallway with or without exoskeleton for 6 minutes. The objective is to cover as much space as possible in 6 minutes. Subjects can slow down or stop to rest if they feel like, but should start walking when they feel they are able. A research team member will walk behind the subject to prevent loss of balance during the test.

  4. Physical demands as measured by energy expenditure, which is measured by the Cosmed K4b2 [ Time Frame: 3 weeks post training ]
    Physical demands during the Timed 25 Feet Walk Test and the Six-Minute Walk Test with and without EKSO will be indicated by energy expenditure. Energy Expenditure will be measured by the K4 b2 Cosmed as follows: Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight. Oxygen consumption will be collected on a breath-by-breath basis measured by a portable metabolic system (K4 b2 Cosmed). Prior to the testing, the system will be calibrated using room air and reference gas mixture. During the testing, the subject will wear a face mask and a heart rate monitor at all times and will be asked to breathe normally.

  5. Cognitive demands as indicated by reaction time in dual task paradigm [ Time Frame: 3 weeks post training ]
    Cognitive demands during walking with and without exoskeleton will be determined by reaction time using a dual-task paradigm. We chose a simple reaction task (RT), in which the response will be biting on a pressure sensor to make the response pathways as independent as possible from the motor pathways of locomotion. The secondary RT task consists of biting a pressure transducer placed in the mouth in response to an unpredictable sensory (will not cause pain) electrical stimulation applied by an electrode on the back of the neck without changing walking speed and pattern. The stimulation intensity will be adjusted for each individual before data collection. Shorter RT indicates that reduced amount of attentional resources are required.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02519244


Contacts
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Contact: Shuo-Hsiu Chang, PT, PhD 713-799-7016 shuo-hsiu.chang@uth.tmc.edu
Contact: Ruta Paranjape, MS 713-797-7132 ruta.pranjape@uth.tmc.edu

Locations
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United States, Texas
TIRR Memorial Hermann Recruiting
Houston, Texas, United States, 77030
Contact: Shuo-Hsiu Chang, PT, PhD    713-799-7016    shuo-hsiu.chang@uth.tmc.edu   
Contact: Marcie Kern, PT, MS    713-799-5051    Marcie.Kern@memorialhermann.org   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
National Multiple Sclerosis Society
Texas Woman's University
Investigators
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Principal Investigator: Shuo-Hsiu Chang, PT, PhD The University of Texas Health Science Center, Houston

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Responsible Party: Shuo-Hsiu Chang, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02519244     History of Changes
Other Study ID Numbers: HSC-MS-15-0278
PP3394 ( Other Grant/Funding Number: National Multiple Sclerosis Society )
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: June 13, 2016
Last Verified: June 2016

Keywords provided by Shuo-Hsiu Chang, The University of Texas Health Science Center, Houston:
Multiple Sclerosis
Ambulation
Rehabilitation
Wearable Robotic Devices

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases