Back to resultsInvestigational Study of the Ekso for High-Dosage Use by Individuals With SCI in a Non-Clinical Environment
Primary Purpose
Spinal Cord Injuries
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ekso
Sponsored by
About this trial
This is an interventional supportive care trial for Spinal Cord Injuries
Eligibility Criteria
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.
Sites / Locations
- Ekso Bionics
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ekso Users
Arm Description
SCI subjects using Ekso
Outcomes
Primary Outcome Measures
Number of Study Participants With Adverse Events
evaluate the safety of a subject walking with a lay spotter in a non-clinical environment
Secondary Outcome Measures
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.
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
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?
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.
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?"
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.
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
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.
Length of Participation in Study
Number of months that a participant utilized the Ekso in their home with a lay spotter
Secondary Health Conditions
Frequency of secondary health complications as reported by participants
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02566850
Brief Title
Investigational Study of the Ekso for High-Dosage Use by Individuals With SCI in a Non-Clinical Environment
Official Title
Investigational Study of the Ekso Bionics Powered Exoskeleton for High-Dosage Use by Individuals With Spinal Cord Injury in a Non-Clinical Environment
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
Preliminary results acceptable, investigators moved attention to different project
Study Start Date
January 2014 (undefined)
Primary Completion Date
July 25, 2017 (Actual)
Study Completion Date
July 25, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ekso Bionics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ekso Users
Arm Type
Experimental
Arm Description
SCI subjects using Ekso
Intervention Type
Device
Intervention Name(s)
Ekso
Other Intervention Name(s)
Ekso GT
Intervention Description
powered lower extremity exoskeleton
Primary Outcome Measure Information:
Title
Number of Study Participants With Adverse Events
Description
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
Secondary Outcome Measure Information:
Title
International Spinal Cord Injury Data Sets Quality of Life Basic Data Set
Description
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
Title
International Spinal Cord Injury Data Sets Bowel Function Basic Data Set
Description
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
Title
International Spinal Cord Injury Data Sets Bladder Function Basic Data Set - Number of Participants Who Reported Changes in Bladder Function
Description
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
Title
Spasticity as Tested by the Modified Ashworth Scale
Description
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
Title
International Spinal Cord Injury Data Sets
Description
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
Title
Spinal Cord Independence Measure (SCIM) II
Description
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
Title
Strength Via Upper and Lower Extremity Motor Scors (ISNCSCI Exam)
Description
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
Title
Borg Perceived Rate of Exertion
Description
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
Title
Length of Participation in Study
Description
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
Title
Secondary Health Conditions
Description
Frequency of secondary health complications as reported by participants
Time Frame
Through study completion for a maximum possible duration of 42 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Ekso Bionics
City
Richmond
State/Province
California
ZIP/Postal Code
94804
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Investigational Study of the Ekso for High-Dosage Use by Individuals With SCI in a Non-Clinical Environment
We'll reach out to this number within 24 hrs