Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Glostrup University Hospital, Copenhagen | OTHER |
This study is to evaluate the performance attributes and user progression of participants with motor complete and incomplete spinal cord injury (SCI) while utilizing the Ekso robotic exoskeleton in an eight week over ground, locomotor program. We hypothesize an improvement in progression and overall health while using Ekso.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ekso treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ekso | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Adherent to Gait Training Progression Using Ekso | Participants were scheduled to utilize exoskeleton 3x per week for 8 weeks. The number of participants who completed this dose was tracked. | 24 sessions |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular Effect | The heart rate and blood pressure while sitting, at rest, and during activity will be taken to measure cardiovascular health changes. The perceived rate of exertion will also be used to determine cardiovascular effect. | baseline (1st session), session #1, session #12, session #24, followup at 12 weeks. Sessions occur 3x/week over an 8 week training period with a follow up visit at week 12. |
Not provided
Inclusion Criteria:
Max hip width= 16.5" or 42cm Upper leg length= 20" to 24â…›" or 51cm to 61.4cm Lower leg length= 19" to 25" or 48cm to 63.4cm
Maximum weight of 100 kilograms (220 pounds)
Sufficient upper extremity (UE) strength to use a front wheeled walker (FWW) either by manual muscle testing (MMT) (minimum triceps strength bilaterally of 3/5, shoulder abduction/adduction and flexion/extension 4/5) and/or by functional standing test with FWW. Participants with impaired hand function may use cuff grips.
Sufficient range of motion (ROM) to achieve a normal, reciprocal gait pattern, and normal sit to stand transitions.
Demonstrate adequate trunk stability and upper extremity strength to utilize Ekso as evidenced by the ability to complete a level (or near level) surface wheelchair to mat transfer with minimal assistance.
Medically stable and cleared by a physician for full weight bearing locomotor training including 15 minute standing frame trial to assess standing tolerance
Exclusion Criteria:
Have trained in Ekso in the past except for one or two training/demonstration sessions
Utilizing another robotic device for locomotor training
Any medical issue that in the opinion of the Investigator precludes full weight bearing locomotor training including but not limited to:
Any medical issue that in the opinion of the Investigator would affect participant safety either due to cognitive deficits/impulsivity, intolerance to mild exercise or other factors
Any issue that in the opinion of the Investigator would confound results such as a concurrent neurological injury or disorder (other than SCI) or other factors
Modified Ashworth Scale (MAS) = 4 in the majority of lower extremity joints (e.g. greater than or equal to four joint movements in bilateral lower extremities when testing hip flexion/extension, knee flexion/extension, ankle dorsi/plantar flexion)
Skin integrity issues in areas that contact the device (including abdominal ostomies) or that would prohibit sitting
Pregnancy
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Fin Biering-Sorensen, MD | Glostrup University Hospital, Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glostrup Hospital | Hornbæk | Denmark | ||||
| Universitats-und Rehabilitationskliniken |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ekso Treatment | Ekso gait training 3x/week for 8 weeks. Utilized the EksoGT device for approximately 60 minutes per session |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
8 participants who did not complete the study were not included in data synthesis or analysis - for this reason, only 52 participants were included below, which is different from the 60 who began the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ekso Treatment | Ekso gait training 3x/week for 8 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Participants Adherent to Gait Training Progression Using Ekso | Participants were scheduled to utilize exoskeleton 3x per week for 8 weeks. The number of participants who completed this dose was tracked. | Posted | Count of Participants | Participants | 24 sessions |
|
|
Study duration of 8 weeks plus 4 weeks of follow up
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ekso Treatment | Ekso gait training 3x/week for 8 weeks. While outcome measures were assessed in two groups, Recently Injured and Chronically Injured, adverse events were measured in one group out of all total participants because all participants underwent the same intervention (ie this one a 1-arm study) |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ankle swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carsten Bach Baunsgaard | Clinic for Spinal Cord Injuries, Rigshospitalet, University of Copenhagen | 1111111111 | carsten.bach.baunsgaard@regionh.dk |
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Impact of Ekso Training on Spasticity | The impact of Ekso training on muscle spasticity will be measured using the Modified Ashworth Scale (MAS) | baseline (1st session), session #12, session #24, followup at 12 weeks. Sessions occur 3x/week over an 8 week training period with a follow up visit at week 12. |
| Timed Up and Go (TUG) | Impact of Ekso training on gait in participants who are ambulatory prior to Ekso training will be evaluated while not wearing the exoskeleton. Participants evaluated are those with ambulatory abilities outside of Ekso and therefore can complete test. This ambulatory ability could have been present at baseline testing, or participants may have acquired walking ability during the course of this study. Participant begins in a standard arm chair sitting back, stands, walks 3 meters, turns around, walks back, and sits into the chair. The time it takes to complete this sequence of movements is tracked. | baseline (1st session), session #12, session #24, followup at 12 weeks. Sessions occur 3x/week over an 8 week training period with a follow up visit at week 12. |
| Muscle Strength | The muscle strength of each of 5 key lower extremity muscles on each leg will be analyzed on a scale of 0-5. Lower extremity muscle scores are then added together to give a full lower extremity muscle score with a minimum score of 0 and a maximum score of 50. For each muscle: 0=None; No visible or palpable contraction. 1=Trace; Visible or palpable contraction with no motion. 2=Poor; Full range of motion (ROM) gravity eliminated. 3=Fair; Full ROM against gravity. 4=Good; Full ROM against gravity, moderate resistance. 5=Normal; Full ROM against gravity, maximal resistance. Higher LEMS scores (closer to 50) indicate higher strength towards typical, unimpaired muscle strength. Scores that are lower, close to or at 0, indicate little to no strength in the lower extremities. | baseline (1st session), after session #1, session #12, session #24, followup at 12 weeks. Sessions occur 3x/week over an 8 week training period with a follow up visit at week 12. |
| Change in Bladder Function | Evaluate the function of bowel and bladder as impacted by Ekso training using Modified International SCI Lower Urinary Tract Basic Data Set | baseline (1st session), after session #1, session #12, session #24, followup at 12 weeks. Sessions occur 3x/week over an 8 week training period with a follow up visit at week 12. |
| Functional Abilities | Functional abilities will be measured based on Spinal Cord Independence Measure II (SCIM II). This assessment is scored from 0-100 with higher numbers equating to higher function/ more independence. | baseline, session #12, session #24, followup at 12 weeks. Sessions occur 3x/week over an 8 week training period with a follow up visit at week 12. |
| Change in Bowel Function | The effect of Ekso training on bowel function will be evaluated using Modified International SCI Bowel Function Basic Data Set | baseline (1st session), session #24, followup at 12 weeks. Sessions occur 3x/week over an 8 week training period with a follow up visit at week 12. |
| Quality of Life - Satisfaction of Life | The Quality of Life change due to Ekso training will be evaluated using the International SCI Quality of Life Basic Data Sheet. Scores are from 1-10 with 1= completely dissatisfied and 10=completely satisfied. | baseline (1st session),session #24, followup at 12 weeks. Sessions occur 3x/week over an 8 week training period with a follow up visit at week 12. |
| Berg Balance Scale (BBS) - Balance | Impact of Ekso training on gait in participants who are ambulatory prior to Ekso training. Gait progression will be evaluated in individuals with motor incomplete SCI who are ambulatory outside of Ekso. They will utilize Berg Balance Scale (BBS) to measure balance. The BBS includes 14 tasks each scored from 0-4, and the point value given for each of the 14 items is then summed together to yield a final score. Total BBS scores are out of 56 possible points where the higher the score, the better the balance is and therefore the lower the risk of falls. Scores can range from 0 to 56. A score or <45/56 is a commonly used standard that indicates individuals may be at greater risk of falling | baseline (1st session), session #12, session #24, followup at 12 weeks. Sessions occur 3x/week over an 8 week training period with a follow up visit at week 12. |
| 10 Meter Walk Test - Gait Speed | Impact of Ekso training on gait in participants who are ambulatory prior to Ekso training. Gait progression will be evaluated in individuals with motor incomplete SCI who are ambulatory outside of Ekso. They will utilize a 10 Meter Walk Test to analyze gait speed. Participants will walk over a 10 meter strip and the time taken to complete this is recorded. | baseline (1st session), session #12, session #24, followup at 12 weeks. Sessions occur 3x/week over an 8 week training period with a follow up visit at week 12. |
| Gait Progression | Impact of Ekso training on gait in participants who are ambulatory prior to Ekso training. Gait progression will be evaluated in individuals with motor incomplete SCI who are ambulatory outside of Ekso. They will utilize the Walking Index for Spinal Cord Injury II (WISCI II) and note any changes in walking assistive device utilized. Scores on the WISCI II range from 0 to 20. A higher score indicates the participant can walk more independently (from braces, assistive device, and hands on assistance) whereas a lower score indicates that a participants requires assistance from a brace, assistive device, and/or another person. | baseline (1st session), session #12, session #24, followup at 12 weeks. Sessions occur 3x/week over an 8 week training period with a follow up visit at week 12. |
| Ulm |
| Germany |
| Heliomare Revalidatie | Wijk aan Zee | Netherlands |
| Sunnaas Sykehus HF | Oslo | Norway |
| Institut Guttmann, Neurorehabilitation Hospital | Barcelona | Spain |
| Fundacion Lesionado Medular | Madrid | Spain |
| Clinical Department of Rehabilitation Medicine and Department of Medicine and Health Services | Linköping | Sweden |
| Sinalenheten, Akademiska Sjukhuset | Uppsala | Sweden |
| Swiss Paraplegic Center (SPZ) | Nottwil | Switzerland |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Inter-Quartile Range | kilogram/meters^2 |
|
| Time since injury | Count of Participants | Participants |
|
| Neurological level of injury (NLI) and severity of injury at baseline | In participants with spinal cord injury, NLI refers to the most caudal/inferior segment of the cord with intact sensation and antigravity muscle function strength, provided that there is normal (intact) sensory and motor function rostrally/above. The American Spinal Injury Association impairment scale (AIS) is used to measure this and determine the completeness of injury which tells about sensation or function below that level. AIS D is separated because these patients are motor incomplete and therefore have a more positive prognosis. | Count of Participants | Participants |
|
| Spinal cord injury aetiology | Count of Participants | Participants |
|
|
| Secondary | Cardiovascular Effect | The heart rate and blood pressure while sitting, at rest, and during activity will be taken to measure cardiovascular health changes. The perceived rate of exertion will also be used to determine cardiovascular effect. | Data not collected | Posted | baseline (1st session), session #1, session #12, session #24, followup at 12 weeks. Sessions occur 3x/week over an 8 week training period with a follow up visit at week 12. |
|
|
| Secondary | Impact of Ekso Training on Spasticity | The impact of Ekso training on muscle spasticity will be measured using the Modified Ashworth Scale (MAS) | Data not collected | Posted | baseline (1st session), session #12, session #24, followup at 12 weeks. Sessions occur 3x/week over an 8 week training period with a follow up visit at week 12. |
|
|
| Secondary | Timed Up and Go (TUG) | Impact of Ekso training on gait in participants who are ambulatory prior to Ekso training will be evaluated while not wearing the exoskeleton. Participants evaluated are those with ambulatory abilities outside of Ekso and therefore can complete test. This ambulatory ability could have been present at baseline testing, or participants may have acquired walking ability during the course of this study. Participant begins in a standard arm chair sitting back, stands, walks 3 meters, turns around, walks back, and sits into the chair. The time it takes to complete this sequence of movements is tracked. | Subset analysis based on data collection | Posted | Mean | 95% Confidence Interval | seconds | baseline (1st session), session #12, session #24, followup at 12 weeks. Sessions occur 3x/week over an 8 week training period with a follow up visit at week 12. |
|
|
|
| Secondary | Muscle Strength | The muscle strength of each of 5 key lower extremity muscles on each leg will be analyzed on a scale of 0-5. Lower extremity muscle scores are then added together to give a full lower extremity muscle score with a minimum score of 0 and a maximum score of 50. For each muscle: 0=None; No visible or palpable contraction. 1=Trace; Visible or palpable contraction with no motion. 2=Poor; Full range of motion (ROM) gravity eliminated. 3=Fair; Full ROM against gravity. 4=Good; Full ROM against gravity, moderate resistance. 5=Normal; Full ROM against gravity, maximal resistance. Higher LEMS scores (closer to 50) indicate higher strength towards typical, unimpaired muscle strength. Scores that are lower, close to or at 0, indicate little to no strength in the lower extremities. | Sub analysis completed based on data collected | Posted | Mean | 95% Confidence Interval | units on a scale | baseline (1st session), after session #1, session #12, session #24, followup at 12 weeks. Sessions occur 3x/week over an 8 week training period with a follow up visit at week 12. |
|
|
|
| Secondary | Change in Bladder Function | Evaluate the function of bowel and bladder as impacted by Ekso training using Modified International SCI Lower Urinary Tract Basic Data Set | Data not collected | Posted | baseline (1st session), after session #1, session #12, session #24, followup at 12 weeks. Sessions occur 3x/week over an 8 week training period with a follow up visit at week 12. |
|
|
| Secondary | Functional Abilities | Functional abilities will be measured based on Spinal Cord Independence Measure II (SCIM II). This assessment is scored from 0-100 with higher numbers equating to higher function/ more independence. | 8 total drop outs | Posted | Median | Inter-Quartile Range | score on a scale | baseline, session #12, session #24, followup at 12 weeks. Sessions occur 3x/week over an 8 week training period with a follow up visit at week 12. |
|
|
|
| Secondary | Change in Bowel Function | The effect of Ekso training on bowel function will be evaluated using Modified International SCI Bowel Function Basic Data Set | Data not collected | Posted | baseline (1st session), session #24, followup at 12 weeks. Sessions occur 3x/week over an 8 week training period with a follow up visit at week 12. |
|
|
| Secondary | Quality of Life - Satisfaction of Life | The Quality of Life change due to Ekso training will be evaluated using the International SCI Quality of Life Basic Data Sheet. Scores are from 1-10 with 1= completely dissatisfied and 10=completely satisfied. | 8 total dropouts | Posted | Median | Inter-Quartile Range | score on a scale | baseline (1st session),session #24, followup at 12 weeks. Sessions occur 3x/week over an 8 week training period with a follow up visit at week 12. |
|
|
|
| Secondary | Berg Balance Scale (BBS) - Balance | Impact of Ekso training on gait in participants who are ambulatory prior to Ekso training. Gait progression will be evaluated in individuals with motor incomplete SCI who are ambulatory outside of Ekso. They will utilize Berg Balance Scale (BBS) to measure balance. The BBS includes 14 tasks each scored from 0-4, and the point value given for each of the 14 items is then summed together to yield a final score. Total BBS scores are out of 56 possible points where the higher the score, the better the balance is and therefore the lower the risk of falls. Scores can range from 0 to 56. A score or <45/56 is a commonly used standard that indicates individuals may be at greater risk of falling | Subset of total participants based on data collection | Posted | Mean | 95% Confidence Interval | score on a scale | baseline (1st session), session #12, session #24, followup at 12 weeks. Sessions occur 3x/week over an 8 week training period with a follow up visit at week 12. |
|
|
|
| Secondary | 10 Meter Walk Test - Gait Speed | Impact of Ekso training on gait in participants who are ambulatory prior to Ekso training. Gait progression will be evaluated in individuals with motor incomplete SCI who are ambulatory outside of Ekso. They will utilize a 10 Meter Walk Test to analyze gait speed. Participants will walk over a 10 meter strip and the time taken to complete this is recorded. | Subanalysis completed based on data collected | Posted | Mean | 95% Confidence Interval | seconds | baseline (1st session), session #12, session #24, followup at 12 weeks. Sessions occur 3x/week over an 8 week training period with a follow up visit at week 12. |
|
|
|
| Secondary | Gait Progression | Impact of Ekso training on gait in participants who are ambulatory prior to Ekso training. Gait progression will be evaluated in individuals with motor incomplete SCI who are ambulatory outside of Ekso. They will utilize the Walking Index for Spinal Cord Injury II (WISCI II) and note any changes in walking assistive device utilized. Scores on the WISCI II range from 0 to 20. A higher score indicates the participant can walk more independently (from braces, assistive device, and hands on assistance) whereas a lower score indicates that a participants requires assistance from a brace, assistive device, and/or another person. | Subset analysis based on full data collection | Posted | Mean | 95% Confidence Interval | units on a scale | baseline (1st session), session #12, session #24, followup at 12 weeks. Sessions occur 3x/week over an 8 week training period with a follow up visit at week 12. |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 22 |
| 60 |
| dizziness or sycope | Cardiac disorders | Systematic Assessment |
|
| Neurological symptoms | Nervous system disorders | Systematic Assessment |
|
| Skin issues | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Concurrent medical issues | General disorders | Systematic Assessment |
|
Not provided
Not provided
| D014947 | Wounds and Injuries |
| Session 24 |
|
| Follow up |
|
| Follow up |
|
| Follow up |
|
| Follow up |
|
| Session 24 |
|
| Follow up |
|
| Session 24 |
|
| Follow up |
|
| Session 24 |
|
| Follow up |
|