Trial Outcomes & Findings for Wearable Lower Extremity Exoskeleton to Promote Walking in Persons With Multiple Sclerosis (NCT NCT02519244)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

baseline

Results posted on

2019-05-29

Participant Flow

11 were enrolled; however, one person did not initiate the intervention because they were scheduled for knee surgery.

Participant milestones

Participant milestones
Measure	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. 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.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Robot-assisted Rehabilitation n=10 Participants 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. 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.
Age, Continuous	54.3 years STANDARD_DEVIATION 12.4 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race/Ethnicity, Customized African American	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	4 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants
Weight	70 kilograms STANDARD_DEVIATION 12 • n=5 Participants
Height	1.68 meters STANDARD_DEVIATION 0.09 • n=5 Participants
Multiple Sclerosis Type Primary Progressive Multiple Sclerosis (PPMS)	3 Participants n=5 Participants
Multiple Sclerosis Type Relapsing-Remitting Multiple Sclerosis (RRMS)	5 Participants n=5 Participants
Multiple Sclerosis Type Secondary Progressive Multiple Sclerosis (SPMS)	2 Participants n=5 Participants
Years Since Diagnosis	15 years STANDARD_DEVIATION 7.1 • n=5 Participants
Kurtzke Expanded Disability Status Scale (EDSS)	6.55 units on a scale STANDARD_DEVIATION 0.44 • n=5 Participants

PRIMARY outcome

Timeframe: baseline

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.

Outcome measures

Outcome measures
Measure	Robot-assisted Rehabilitation n=10 Participants 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. 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.
Speed in the Timed 25 Feet Walk Test at Self-selected Speed (Without Exoskeleton)	0.35 meters per second (m/s) Standard Deviation 0.18

PRIMARY outcome

Timeframe: 3 weeks

Population: For two of the subjects not reported, there were technical issues during assessment.

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.

Outcome measures

Outcome measures
Measure	Robot-assisted Rehabilitation n=8 Participants 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. 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.
Speed in the Timed 25 Feet Walk Test at Self-selected Speed (Without Exoskeleton)	0.46 meters per second (m/s) Standard Deviation 0.24

PRIMARY outcome

Timeframe: 3 weeks

Population: For two of the subjects not reported, there were technical issues during assessment.

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.

Outcome measures

Outcome measures
Measure	Robot-assisted Rehabilitation n=8 Participants 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. 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.
Speed in the Timed 25 Feet Walk Test at Self-selected Speed (With Exoskeleton)	0.30 meters per second (m/s) Standard Deviation 0.09

PRIMARY outcome

Timeframe: baseline

Population: One subject did not perform the Timed 25 Feet Walk Test at fast speed because they were only able to walk at the self-selected speed.

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.

Outcome measures

Outcome measures
Measure	Robot-assisted Rehabilitation n=9 Participants 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. 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.
Speed in the Timed 25 Feet Walk Test at Fast Speed (Without Exoskeleton)	0.51 meters per second (m/s) Standard Deviation 0.24

PRIMARY outcome

Timeframe: 3 weeks

Population: One subject did not perform the Timed 25 Feet Walk Test at fast speed because they were only able to walk at the self-selected speed.For one of the subjects not reported, there were technical issues during assessment.

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.

Outcome measures

Outcome measures
Measure	Robot-assisted Rehabilitation n=8 Participants 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. 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.
Speed in the Timed 25 Feet Walk Test at Fast Speed (Without Exoskeleton)	0.61 meters per second (m/s) Standard Deviation 0.32

PRIMARY outcome

Timeframe: 3 weeks

Population: For two of the subjects not reported, there were technical issues during assessment.

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.

Outcome measures

Outcome measures
Measure	Robot-assisted Rehabilitation n=8 Participants 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. 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.
Speed in the Timed 25 Feet Walk Test at Fast Speed (With Exoskeleton)	0.33 meters per second (m/s) Standard Deviation 0.11

PRIMARY outcome

Timeframe: baseline

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.

Outcome measures

Outcome measures
Measure	Robot-assisted Rehabilitation n=10 Participants 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. 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.
Distance Walked During the Six-minute Walk Test (Without Exoskeleton)	121.15 meters Standard Deviation 64.66

PRIMARY outcome

Timeframe: 3 weeks

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.

Outcome measures

Outcome measures
Measure	Robot-assisted Rehabilitation n=8 Participants 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. 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.
Distance Walked During the Six-minute Walk Test (Without Exoskeleton)	138.90 meters Standard Deviation 66.89

PRIMARY outcome

Timeframe: 3 weeks

Population: For two of the subjects not reported, there were technical issues during assessment.

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.

Outcome measures

Outcome measures
Measure	Robot-assisted Rehabilitation n=8 Participants 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. 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.
Distance Walked During the Six-minute Walk Test (With Exoskeleton)	108.09 meters Standard Deviation 26.26

PRIMARY outcome

Timeframe: baseline

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.

Outcome measures

Outcome measures
Measure	Robot-assisted Rehabilitation n=10 Participants 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. 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.
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)	2.83 ml/min/Kg Standard Deviation 1.12

PRIMARY outcome

Timeframe: 3 weeks

Population: For two of the subjects not reported, there were technical issues during assessment.

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.

Outcome measures

Outcome measures
Measure	Robot-assisted Rehabilitation n=8 Participants 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. 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.
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)	5.72 ml/min/Kg Standard Deviation 1.06

PRIMARY outcome

Timeframe: 3 weeks

Population: For two of the subjects not reported, there were technical issues during assessment.

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.

Outcome measures

Outcome measures
Measure	Robot-assisted Rehabilitation n=8 Participants 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. 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.
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)	6.33 ml/min/Kg Standard Deviation 1.32

PRIMARY outcome

Timeframe: baseline

Population: One subject did not perform the Timed 25 Feet Walk Test at Fast Speed due to fatigue. For another subject, data was not collected for the the Timed 25 Feet Walk Test at Fast Speed due to a technical error.

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.

Outcome measures

Outcome measures
Measure	Robot-assisted Rehabilitation n=8 Participants 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. 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.
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)	3.6 ml/min/Kg Standard Deviation 1.31

PRIMARY outcome

Timeframe: 3 weeks

Population: One subject did not perform the Timed 25 Feet Walk Test at Fast Speed due to fatigue. For another subject, there was a technical error during the assessment.

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.

Outcome measures

Outcome measures
Measure	Robot-assisted Rehabilitation n=8 Participants 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. 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.
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)	6.87 ml/min/Kg Standard Deviation 1.44

PRIMARY outcome

Timeframe: 3 weeks

Population: For two of the subjects not reported, there were technical issues during assessment.

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.

Outcome measures

Outcome measures
Measure	Robot-assisted Rehabilitation n=8 Participants 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. 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.
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)	7.59 ml/min/Kg Standard Deviation 1.32

PRIMARY outcome

Timeframe: baseline

Population: One subject did not perform the Timed 25 Feet Walk Test at Fast Speed due to fatigue. For another subject, there was a technical error during the assessment.

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.

Outcome measures

Outcome measures
Measure	Robot-assisted Rehabilitation n=10 Participants 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. 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.
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)	5.76 ml/min/Kg Standard Deviation 1.25

PRIMARY outcome

Timeframe: 3 weeks

Population: One subject did not perform the Timed 25 Feet Walk Test at Fast Speed due to fatigue. For another subject, there was a technical error during the assessment.

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.

Outcome measures

Outcome measures
Measure	Robot-assisted Rehabilitation n=8 Participants 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. 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.
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)	10.20 ml/min/Kg Standard Deviation 0.90

PRIMARY outcome

Timeframe: 3 weeks

Population: For two of the subjects not reported, there were technical issues during assessment.

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.

Outcome measures

Outcome measures
Measure	Robot-assisted Rehabilitation n=8 Participants 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. 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.
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)	7.77 ml/min/Kg Standard Deviation 1.12

SECONDARY outcome

Timeframe: 3 weeks

Population: For three of the subjects not reported, there were technical issues during assessment.

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.

Outcome measures

Outcome measures
Measure	Robot-assisted Rehabilitation n=7 Participants 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. 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.
Cognitive Demands as Indicated by Reaction Time in Dual Task Paradigm (Without Exoskeleton)	0.51 seconds Standard Deviation 0.15

SECONDARY outcome

Timeframe: 3 weeks

Population: For three of the subjects not reported, there were technical issues during assessment.

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.

Outcome measures

Outcome measures
Measure	Robot-assisted Rehabilitation n=7 Participants 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. 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.
Cognitive Demands as Indicated by Reaction Time in Dual Task Paradigm (With Exoskeleton)	0.67 seconds Standard Deviation 0.43

SECONDARY outcome

Timeframe: baseline

Population: One subject was not able to perform the Timed Up and Go test because they required support to sit and stand.

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.

Outcome measures

Outcome measures
Measure	Robot-assisted Rehabilitation n=9 Participants 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. 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 (Without Exoskeleton)	33.38 seconds Standard Deviation 12.23

SECONDARY outcome

Timeframe: 3 weeks

Population: One subject was not able to perform the Timed Up and Go test because they required support to sit and stand.

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.

Outcome measures

Outcome measures
Measure	Robot-assisted Rehabilitation n=9 Participants 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. 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 (Without Exoskeleton)	28.64 seconds Standard Deviation 13.74

SECONDARY outcome

Timeframe: baseline

MSQOL-54 physical health composite scores range from 0 to 100, with a higher scale score indicating improved quality of life

Outcome measures

Outcome measures
Measure	Robot-assisted Rehabilitation n=10 Participants 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. 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.
Quality of Life as Assessed by the Multiple Sclerosis Quality of Life-54 (MSQOL-54) Questionnaire - Physical Health Composite Score	58.3 score Standard Deviation 12.3

SECONDARY outcome

Timeframe: 3 weeks

MSQOL-54 physical health composite scores range from 0 to 100, with a higher scale score indicating improved quality of life

Outcome measures

Outcome measures
Measure	Robot-assisted Rehabilitation n=10 Participants 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. 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.
Quality of Life as Assessed by the Multiple Sclerosis Quality of Life-54 (MSQOL-54) Questionnaire - Physical Health Composite Score	57.6 score Standard Deviation 13.6

SECONDARY outcome

Timeframe: baseline

MSQOL-54 mental health composite scores range from 0 to 100, with a higher scale score indicating improved quality of life

Outcome measures

Outcome measures
Measure	Robot-assisted Rehabilitation n=10 Participants 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. 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.
Quality of Life as Assessed by the Multiple Sclerosis Quality of Life-54 (MSQOL-54) Questionnaire - Mental Health Composite Score	80.1 score Standard Deviation 10.7

SECONDARY outcome

Timeframe: 3 weeks

MSQOL-54 mental health composite scores range from 0 to 100, with a higher scale score indicating improved quality of life

Outcome measures

Outcome measures
Measure	Robot-assisted Rehabilitation n=10 Participants 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. 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.
Quality of Life as Assessed by the Multiple Sclerosis Quality of Life-54 (MSQOL-54) Questionnaire - Mental Health Composite Score	78.8 score Standard Deviation 13.2

Adverse Events

Robot-assisted Rehabilitation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Shuo-Hsiu Chang, PT, PhD

The University of Texas Health Science Center at Houston

Phone: 713-799-7016

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place