Spinal Cord Injuries
Conditions
Brief summary
The purpose of the study is to study the safety and health effects of using the Ekso Bionics powered exoskeleton device in a home setting over an extended period, ranging from 12-42 months.
Detailed description
This is a 36 month exploratory Investigational Study compliant with the NSF Human Subjects regulations (45 CFR 690) trialing a new device for the SCI populations to aid in ambulatory function in a home setting. Ekso Bionics will enable up to twelve (12) subjects with SCI to use an Ekso device in their home for a 12-month period. Qualified subjects will help Ekso Bionics determine the practical use of the device in the home environment and will enable Ekso Bionics to gather data to develop a device for use in a home environment. The study will require a trained spotter to be present at all times that the device is being used. The study will also evaluate the effectiveness of a non-medically licensed spotter to assist the subject.
Interventions
DEVICEEkso
powered lower extremity exoskeleton
Sponsors
Ekso Bionics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* be an experienced user of the Ekso device with a minimum of 20 hours and no more than 50 hours of device use and require no greater than minimal assist (support of up to 25% body weight) for safe and consistent walking. * no more than 2 episodes of balance loss per 1 hour training session that require no more than moderate assistance (support of 26% to 50% of body weight) * participants with more than 50 hours of device experience must agree to a 1 month period of non-use prior to acquisition of baseline measures * be between 18-65 years of age. * be able to physically fit into the exoskeleton device. * be able to tolerate upright standing for up to 60 minutes. * have sufficient joint range of motion to fit safely within Ekso: Hip flexion contracture ≤ 15o; knee flexion contracture ≤ 10o; ankle dorsiflexion to neutral with no more than 10o of knee flexion. * have sufficient upper body strength to balance themselves with two arms * be fluent in English
Exclusion criteria
* Height below 60 inches or above 76 inches or with physical characteristics incompatible with device and testing procedure. * Weight above 220 lbs. * Lower extremity joint contractures that exceed device capacity for safe use. * Any medical issue that precludes full weight bearing and ambulation (e.g. osteoporosis that prevents safe standing, orthopedic injuries, pain, severe spasticity) * Skin integrity issues that would prevent wearing the device. * Cognitive and/or communicative disability inappropriate for testing as determined by Ekso Bionics clinician. Subjects must be able to follow directions well and demonstrate learning capability. * Pregnancy (Self-reported) * Colostomy * Medical or environmental conditions arising after the start of the study that are deemed unsafe per Ekso Bionics discretion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Study Participants With Adverse Events | through study completion for a maximum possible duration of 42 months | evaluate the safety of a subject walking with a lay spotter in a non-clinical environment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International Spinal Cord Injury Data Sets Bowel Function Basic Data Set | through study completion for a maximum possible duration of 42 months | evaluate the impact on subject's bowel health, subjective questionnaire. Examined time required for defecation in minutes, with shorter time being more favorable |
| International Spinal Cord Injury Data Sets Bladder Function Basic Data Set - Number of Participants Who Reported Changes in Bladder Function | through study completion for a maximum possible duration of 42 months | evaluate the impact on subject's bladder health, subjective feedback and written answers collected, no numerical scoring is part of this exam. This data set asks the following questions: Urinary tract impairment unrelated to spinal cord lesion? Awareness of the need to empty the bladder? How does bladder emptying occur? Average number of voluntary bladder emptyings per 24 hours during the last week? Any involuntary urine leakage (urinary incontinence) within the last four weeks? Collecting appliances for urinary incontinence? Any drugs with possible influence on the urinary tract within the last four weeks? Surgical procedures on the urinary tract? Any change in lower urinary tract symptoms within the last year? |
| Spasticity as Tested by the Modified Ashworth Scale | through study completion for a maximum possible duration of 42 months | evaluate the impact on subject's spasticity, assessed Elbow Flexors / Extensors, Wrist Flexors / Extensors, Hip Flexors / Extensors, Hip Abductors, Knee Flexors / Extensors, Ankle Plantar Flexors, Ankle Invertors and totaled spasticity for each group (0-5 for right and left) to total between 0 and 70. Higher scores for each muscle group indicate more rigid spasticity, and higher total score indicates more muscle groups involved. |
| International Spinal Cord Injury Data Sets | through study completion for a maximum possible duration of 42 months | evaluate the impact on subject's pain. Totaled the following questions with scales from 0-10 for a total score ranging from 0-50. For each question, 0 = No interference, 10 = Extreme interference How much has pain changed your ability to take part in recreational and other social activities? How much has pain changed the amount of satisfaction or enjoyment you get from family related activities? In general, how much has pain interfered with your day to day activities in the last week? In general, how much has pain interfered with your overall mood in the past week? In general, how much has pain interfered with your ability to get a good night's sleep? |
| International Spinal Cord Injury Data Sets Quality of Life Basic Data Set | through study completion for a maximum possible duration of 42 months | Consists of 3 variables: ratings of satisfaction with general quality of life, satisfaction with physical health, and satisfaction with psychological health. All variables are rated on a scale ranging from 0 (completely dissatisfied) to 10 (completely satisfied) with a total of 30 points. |
| Strength Via Upper and Lower Extremity Motor Scors (ISNCSCI Exam) | through study completion for a maximum possible duration of 42 months | evaluate the impact on subject's muscle strength. Total upper and lower extremity motor scores (0-5 for right and left) for each of the following muscle groups for a total of 120 points. For each muscle group, 0 is defined as no palpable contraction, while 5 is full strength. Shoulder Flexion Shoulder Extension Elbow Flexion Elbow Extension Wrist Extension Gross Grip Strength Hip Flexion Hip Extension Hip Abduction Knee Extension Ankle Dorsiflexion Ankle Plantar Flexion |
| Borg Perceived Rate of Exertion | through study completion for a maximum possible duration of 42 months | evaluate the impact on subject's effort while walking. Measure taken for each session on scale from 6-20. Average was taken from each participant over their total number of sessions. Higher scores on the Borg indicates the participants feels like they are working harder. |
| Length of Participation in Study | through study completion for a maximum possible duration of 42 months | Number of months that a participant utilized the Ekso in their home with a lay spotter |
| Secondary Health Conditions | Through study completion for a maximum possible duration of 42 months | Frequency of secondary health complications as reported by participants |
| Spinal Cord Independence Measure (SCIM) II | through study completion for a maximum possible duration of 42 months | evaluate the impact on subject's functional abilities in 3 domains (self care, respiration and sphicter management, mobility) on a scale from 0-100. Each of the 17 total questions have multiple options that are scored in different values. Some questions range from 0-1 points, while others range from 0-2,0-3, 0-5, 0-8, 0-6,0-10, or 0-15. Higher values for each question, and overall, indicate more independence with the task, while lower scores indicates requiring of more assistance. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ekso Users SCI subjects using Ekso
Ekso: powered lower extremity exoskeleton | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Ekso Users |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 39.5 years |
| ASIA impairment scale (AIS) AIS A (motor and sensory complete) | 3 Participants |
| ASIA impairment scale (AIS) AIS B (motor complete) | 0 Participants |
| ASIA impairment scale (AIS) AIS C (incomplete) | 1 Participants |
| ASIA impairment scale (AIS) AIS D (incomplete) | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
Number of Study Participants With Adverse Events
evaluate the safety of a subject walking with a lay spotter in a non-clinical environment
Time frame: through study completion for a maximum possible duration of 42 months
Population: One dropout from original 4 participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ekso Users | Number of Study Participants With Adverse Events | 0 Participants |
Secondary
Borg Perceived Rate of Exertion
evaluate the impact on subject's effort while walking. Measure taken for each session on scale from 6-20. Average was taken from each participant over their total number of sessions. Higher scores on the Borg indicates the participants feels like they are working harder.
Time frame: through study completion for a maximum possible duration of 42 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ekso Users | Borg Perceived Rate of Exertion | 8.98 score on a scale |
Secondary
International Spinal Cord Injury Data Sets
evaluate the impact on subject's pain. Totaled the following questions with scales from 0-10 for a total score ranging from 0-50. For each question, 0 = No interference, 10 = Extreme interference How much has pain changed your ability to take part in recreational and other social activities? How much has pain changed the amount of satisfaction or enjoyment you get from family related activities? In general, how much has pain interfered with your day to day activities in the last week? In general, how much has pain interfered with your overall mood in the past week? In general, how much has pain interfered with your ability to get a good night's sleep?
Time frame: through study completion for a maximum possible duration of 42 months
Population: One dropout from original 4 participants
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Ekso Users | International Spinal Cord Injury Data Sets | baseline/Pre intervention | 13.67 units on a scale |
| Ekso Users | International Spinal Cord Injury Data Sets | post intervention up to 42 months | 4.67 units on a scale |
Secondary
International Spinal Cord Injury Data Sets Bladder Function Basic Data Set - Number of Participants Who Reported Changes in Bladder Function
evaluate the impact on subject's bladder health, subjective feedback and written answers collected, no numerical scoring is part of this exam. This data set asks the following questions: Urinary tract impairment unrelated to spinal cord lesion? Awareness of the need to empty the bladder? How does bladder emptying occur? Average number of voluntary bladder emptyings per 24 hours during the last week? Any involuntary urine leakage (urinary incontinence) within the last four weeks? Collecting appliances for urinary incontinence? Any drugs with possible influence on the urinary tract within the last four weeks? Surgical procedures on the urinary tract? Any change in lower urinary tract symptoms within the last year?
Time frame: through study completion for a maximum possible duration of 42 months
Population: One dropout from original 4 participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ekso Users | International Spinal Cord Injury Data Sets Bladder Function Basic Data Set - Number of Participants Who Reported Changes in Bladder Function | 3 Participants |
Secondary
International Spinal Cord Injury Data Sets Bowel Function Basic Data Set
evaluate the impact on subject's bowel health, subjective questionnaire. Examined time required for defecation in minutes, with shorter time being more favorable
Time frame: through study completion for a maximum possible duration of 42 months
Population: One dropout from original 4 participants
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Ekso Users | International Spinal Cord Injury Data Sets Bowel Function Basic Data Set | time required for defectation post intervention up to 42 months | 16.83 minutes |
| Ekso Users | International Spinal Cord Injury Data Sets Bowel Function Basic Data Set | time required for defectation - baseline/pre intervention | 28 minutes |
Secondary
International Spinal Cord Injury Data Sets Quality of Life Basic Data Set
Consists of 3 variables: ratings of satisfaction with general quality of life, satisfaction with physical health, and satisfaction with psychological health. All variables are rated on a scale ranging from 0 (completely dissatisfied) to 10 (completely satisfied) with a total of 30 points.
Time frame: through study completion for a maximum possible duration of 42 months
Population: One dropout from original 4 participants
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Ekso Users | International Spinal Cord Injury Data Sets Quality of Life Basic Data Set | Baseline/Pre intervention | 21 score on a scale |
| Ekso Users | International Spinal Cord Injury Data Sets Quality of Life Basic Data Set | Post intervention up to 42 months | 24.33 score on a scale |
Secondary
Length of Participation in Study
Number of months that a participant utilized the Ekso in their home with a lay spotter
Time frame: through study completion for a maximum possible duration of 42 months
Population: one dropout
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ekso Users | Length of Participation in Study | 31.67 months |
Secondary
Secondary Health Conditions
Frequency of secondary health complications as reported by participants
Time frame: Through study completion for a maximum possible duration of 42 months
Population: one dropout
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ekso Users | Secondary Health Conditions | Participants who reported a UTI during study duration | 0 Participants |
| Ekso Users | Secondary Health Conditions | Participants who reported a pressure sore during study duration | 0 Participants |
| Ekso Users | Secondary Health Conditions | Participants who reported no secondary health conditions during study duration | 3 Participants |
Secondary
Spasticity as Tested by the Modified Ashworth Scale
evaluate the impact on subject's spasticity, assessed Elbow Flexors / Extensors, Wrist Flexors / Extensors, Hip Flexors / Extensors, Hip Abductors, Knee Flexors / Extensors, Ankle Plantar Flexors, Ankle Invertors and totaled spasticity for each group (0-5 for right and left) to total between 0 and 70. Higher scores for each muscle group indicate more rigid spasticity, and higher total score indicates more muscle groups involved.
Time frame: through study completion for a maximum possible duration of 42 months
Population: One dropout from original 4 participants
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Ekso Users | Spasticity as Tested by the Modified Ashworth Scale | baseline/pre intervention | 0.67 units on a scale |
| Ekso Users | Spasticity as Tested by the Modified Ashworth Scale | post intervention up to 42 months | 4.67 units on a scale |
Secondary
Spinal Cord Independence Measure (SCIM) II
evaluate the impact on subject's functional abilities in 3 domains (self care, respiration and sphicter management, mobility) on a scale from 0-100. Each of the 17 total questions have multiple options that are scored in different values. Some questions range from 0-1 points, while others range from 0-2,0-3, 0-5, 0-8, 0-6,0-10, or 0-15. Higher values for each question, and overall, indicate more independence with the task, while lower scores indicates requiring of more assistance.
Time frame: through study completion for a maximum possible duration of 42 months
Population: One dropout from original 4 participants
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Ekso Users | Spinal Cord Independence Measure (SCIM) II | baseline/Pre intervention | 71.67 score on a scale |
| Ekso Users | Spinal Cord Independence Measure (SCIM) II | Post intervention up to 42 months | 74 score on a scale |
Secondary
Strength Via Upper and Lower Extremity Motor Scors (ISNCSCI Exam)
evaluate the impact on subject's muscle strength. Total upper and lower extremity motor scores (0-5 for right and left) for each of the following muscle groups for a total of 120 points. For each muscle group, 0 is defined as no palpable contraction, while 5 is full strength. Shoulder Flexion Shoulder Extension Elbow Flexion Elbow Extension Wrist Extension Gross Grip Strength Hip Flexion Hip Extension Hip Abduction Knee Extension Ankle Dorsiflexion Ankle Plantar Flexion
Time frame: through study completion for a maximum possible duration of 42 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Ekso Users | Strength Via Upper and Lower Extremity Motor Scors (ISNCSCI Exam) | baseline/Pre intervention | 69 score on a scale |
| Ekso Users | Strength Via Upper and Lower Extremity Motor Scors (ISNCSCI Exam) | post intervention up to 42 months | 72.3 score on a scale |