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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02519244
• Other study ID #: HSC-MS-15-0278
• Secondary ID: PP3394
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: February 6, 2017

Study information

• Verified date: May 2019
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: February 6, 2017
• Est. primary completion date: February 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
United States	TIRR Memorial Hermann	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Multiple Sclerosis Society, Texas Woman's University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Speed in the Timed 25 Feet Walk Test at Self-selected Speed (Without Exoskeleton)	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. A research team member will walk next to the subject for safety.	baseline
Primary	Speed in the Timed 25 Feet Walk Test at Self-selected Speed (Without Exoskeleton)	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. A research team member will walk next to the subject for safety.	3 weeks
Primary	Speed in the Timed 25 Feet Walk Test at Self-selected Speed (With Exoskeleton)	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. A research team member will walk next to the subject for safety.	3 weeks
Primary	Speed in the Timed 25 Feet Walk Test at Fast Speed (Without Exoskeleton)	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 fast speed. A research team member will walk next to the subject for safety.	baseline
Primary	Speed in the Timed 25 Feet Walk Test at Fast Speed (Without Exoskeleton)	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 fast speed. A research team member will walk next to the subject for safety.	3 weeks
Primary	Speed in the Timed 25 Feet Walk Test at Fast Speed (With Exoskeleton)	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 fast speed. A research team member will walk next to the subject for safety.	3 weeks
Primary	Distance Walked During the Six-minute Walk Test (Without Exoskeleton)	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.	baseline
Primary	Distance Walked During the Six-minute Walk Test (Without Exoskeleton)	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.	3 weeks
Primary	Distance Walked During the Six-minute Walk Test (With Exoskeleton)	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.	3 weeks
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)	Physical demands during the Timed 25 Feet Walk Test will be indicated by energy expenditure. Energy Expenditure (as indicated by VO2-max) 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.; VO2-max, also known as maximal oxygen uptake, is the measurement of the maximum amount of oxygen a person can utilize during exercise.	baseline
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)	Physical demands during the Timed 25 Feet Walk Test will be indicated by energy expenditure. Energy Expenditure (as indicated by VO2-max) 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.; VO2-max, also known as maximal oxygen uptake, is the measurement of the maximum amount of oxygen a person can utilize during exercise.	3 weeks
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)	Physical demands during the Timed 25 Feet Walk Test will be indicated by energy expenditure. Energy Expenditure (as indicated by VO2-max) 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.; VO2-max, also known as maximal oxygen uptake, is the measurement of the maximum amount of oxygen a person can utilize during exercise.	3 weeks
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)	Physical demands during the Timed 25 Feet Walk Test will be indicated by energy expenditure. Energy Expenditure (as indicated by VO2-max) 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.; VO2-max, also known as maximal oxygen uptake, is the measurement of the maximum amount of oxygen a person can utilize during exercise.	baseline
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)	Physical demands during the Timed 25 Feet Walk Test will be indicated by energy expenditure. Energy Expenditure (as indicated by VO2-max) 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.; VO2-max, also known as maximal oxygen uptake, is the measurement of the maximum amount of oxygen a person can utilize during exercise.	3 weeks
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)	Physical demands during the Timed 25 Feet Walk Test will be indicated by energy expenditure. Energy Expenditure (as indicated by VO2-max) 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.; VO2-max, also known as maximal oxygen uptake, is the measurement of the maximum amount of oxygen a person can utilize during exercise.	3 weeks
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)	Physical demands during the Six-Minute Walk Test will be indicated by energy expenditure. Energy Expenditure (as indicated by VO2-max) 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.; VO2-max, also known as maximal oxygen uptake, is the measurement of the maximum amount of oxygen a person can utilize during exercise.	baseline
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)	Physical demands during the Six-Minute Walk Test will be indicated by energy expenditure. Energy Expenditure (as indicated by VO2-max) 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.; VO2-max, also known as maximal oxygen uptake, is the measurement of the maximum amount of oxygen a person can utilize during exercise.	3 weeks
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)	Physical demands during the Six-Minute Walk Test will be indicated by energy expenditure. Energy Expenditure (as indicated by VO2-max) 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.; VO2-max, also known as maximal oxygen uptake, is the measurement of the maximum amount of oxygen a person can utilize during exercise.	3 weeks
Secondary	Cognitive Demands as Indicated by Reaction Time in Dual Task Paradigm (Without Exoskeleton)	Cognitive demands during the Timed 25 Feet Walk Test at self-selected pace with and without exoskeleton will be determined by reaction time using a dual-task paradigm. We chose a simple reaction time (RT) task, 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.	3 weeks
Secondary	Cognitive Demands as Indicated by Reaction Time in Dual Task Paradigm (With Exoskeleton)	Cognitive demands during the Timed 25 Feet Walk Test at self-selected pace with and without exoskeleton will be determined by reaction time using a dual-task paradigm. We chose a simple reaction time (RT) task, 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.	3 weeks
Secondary	Amount of Time Taken to Complete the Time Up and Go Test (Without Exoskeleton)	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.	baseline
Secondary	Amount of Time Taken to Complete the Time Up and Go Test (Without Exoskeleton)	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.	3 weeks
Secondary	Quality of Life as Assessed by the Multiple Sclerosis Quality of Life-54 (MSQOL-54) Questionnaire - Physical Health Composite Score	MSQOL-54 physical health composite scores range from 0 to 100, with a higher scale score indicating improved quality of life	baseline
Secondary	Quality of Life as Assessed by the Multiple Sclerosis Quality of Life-54 (MSQOL-54) Questionnaire - Physical Health Composite Score	MSQOL-54 physical health composite scores range from 0 to 100, with a higher scale score indicating improved quality of life	3 weeks
Secondary	Quality of Life as Assessed by the Multiple Sclerosis Quality of Life-54 (MSQOL-54) Questionnaire - Mental Health Composite Score	MSQOL-54 mental health composite scores range from 0 to 100, with a higher scale score indicating improved quality of life	baseline
Secondary	Quality of Life as Assessed by the Multiple Sclerosis Quality of Life-54 (MSQOL-54) Questionnaire - Mental Health Composite Score	MSQOL-54 mental health composite scores range from 0 to 100, with a higher scale score indicating improved quality of life	3 weeks