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
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Device: Ekso® (Wearable lower limb exoskeleton)||Not Applicable|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Shuo-Hsiu Chang, PT, PhDemail@example.com|
|Contact: Ruta Paranjape, MSfirstname.lastname@example.org|
|United States, Texas|
|TIRR Memorial Hermann||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Shuo-Hsiu Chang, PT, PhD 713-799-7016 email@example.com|
|Contact: Marcie Kern, PT, MS 713-799-5051 Marcie.Kern@memorialhermann.org|
|Principal Investigator:||Shuo-Hsiu Chang, PT, PhD||The University of Texas Health Science Center, Houston|