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Preliminary results acceptable, investigators moved attention to different project
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ekso Users | Experimental | SCI subjects using Ekso |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ekso | Device | powered lower extremity exoskeleton |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Study Participants With Adverse Events | evaluate the safety of a subject walking with a lay spotter in a non-clinical environment | through study completion for a maximum possible duration of 42 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | through study completion for a maximum possible duration of 42 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ekso Bionics | Richmond | California | 94804 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ekso Users | SCI subjects using Ekso Ekso: powered lower extremity exoskeleton |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
four males with SCI
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| ID | Title | Description |
|---|---|---|
| BG000 | Ekso Users | SCI subjects using Ekso Ekso: powered lower extremity exoskeleton |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Study Participants With Adverse Events | evaluate the safety of a subject walking with a lay spotter in a non-clinical environment | One dropout from original 4 participants | Posted | Count of Participants | Participants | through study completion for a maximum possible duration of 42 months |
|
|
Through completion of the study, which could be up to 42 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ekso Users | SCI subjects using Ekso Ekso: powered lower extremity exoskeleton |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katherine Strausser PhD | Ekso Bionics | (510) 529-2529 | kstrausser@eksobionics.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 28, 2015 | May 31, 2023 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 17, 2015 | May 8, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| 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 | through study completion for a maximum possible duration of 42 months |
| 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? | through study completion for a maximum possible duration of 42 months |
| 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. | through study completion for a maximum possible duration of 42 months |
| 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?" | through study completion for a maximum possible duration of 42 months |
| 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. | through study completion for a maximum possible duration of 42 months |
| 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 | through study completion for a maximum possible duration of 42 months |
| 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. | through study completion for a maximum possible duration of 42 months |
| Length of Participation in Study | Number of months that a participant utilized the Ekso in their home with a lay spotter | through study completion for a maximum possible duration of 42 months |
| Secondary Health Conditions | Frequency of secondary health complications as reported by participants | Through study completion for a maximum possible duration of 42 months |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ASIA impairment scale (AIS) | A standardized neurological examination to assess the sensory and motor levels which were affected by SCI. Scale has five classification levels, ranging from complete loss of neural function in the affected area to completely normal. Grades are A->E, where E indicates normal and A indicates no sensory or motor function below the level of injury. | Count of Participants | Participants |
|
|
| 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. | One dropout from original 4 participants | Posted | Mean | Full Range | score on a scale | through study completion for a maximum possible duration of 42 months |
|
|
|
| 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 | One dropout from original 4 participants | Posted | Mean | Full Range | minutes | through study completion for a maximum possible duration of 42 months |
|
|
|
| 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? | One dropout from original 4 participants | Posted | Count of Participants | Participants | through study completion for a maximum possible duration of 42 months |
|
|
|
| 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. | One dropout from original 4 participants | Posted | Mean | Full Range | units on a scale | through study completion for a maximum possible duration of 42 months |
|
|
|
| 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?" | One dropout from original 4 participants | Posted | Mean | Full Range | units on a scale | through study completion for a maximum possible duration of 42 months |
|
|
|
| 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. | One dropout from original 4 participants | Posted | Mean | Full Range | score on a scale | through study completion for a maximum possible duration of 42 months |
|
|
|
| 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 | Posted | Mean | Full Range | score on a scale | through study completion for a maximum possible duration of 42 months |
|
|
|
| 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. | Posted | Mean | Full Range | score on a scale | through study completion for a maximum possible duration of 42 months |
|
|
|
| Secondary | Length of Participation in Study | Number of months that a participant utilized the Ekso in their home with a lay spotter | one dropout | Posted | Mean | Full Range | months | through study completion for a maximum possible duration of 42 months |
|
|
|
| Secondary | Secondary Health Conditions | Frequency of secondary health complications as reported by participants | one dropout | Posted | Count of Participants | Participants | Through study completion for a maximum possible duration of 42 months |
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| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
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| D014947 | Wounds and Injuries |