Performance Attributes and User Progression While Using Ekso

Not Applicable

Completed

• Conditions: Spinal Cord Injury
• Interventions: Device: Ekso

• Registration Number: NCT02132702
• Lead Sponsor: Ekso Bionics

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-02
• Study First Submitted QC: 2014-05-05
• Study First Posted: 2014-05-07
• Study Start: 2014-08
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Results First Submitted: 2023-02-17
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-08
• Last Update Submitted: 2024-07-08
• Results First Posted: 2024-10-07
• Last Update Posted: 2024-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Inpatient or outpatient from 15 through 65 years of age at time of entry into the trial
• Motor complete (ASIA Impairment Scale [AIS] A and B), with a neurological level of injury (NLI) between C7-L2 (inclusive), or motor incomplete (AIS C and D), NLI C1-L2 (inclusive), as determined by the International Standards for Neurological Classification of SCI (ISNCSCI)
• Greater than 30 days since SCI occurred
• Height from 157 - 188 centimeters (5'2" to 6'2") or for individuals who do not meet this criteria the following criteria may be used as assessed per the Ekso operating manual:

Max hip width= 16.5" or 42cm Upper leg length= 20" to 24⅛" 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.

  1. Hip extension greater than or equal to 5 degrees
  2. Knee extension greater than or equal to 5 degrees
  3. Ankle dorsiflexion greater than or equal to 0 degrees

• 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:

  1. Spinal instability (or spinal orthotic unless cleared by physician)
  2. Acute deep vein thrombosis (DVT) with activity restrictions
  3. Severe, recurrent autonomic dysreflexia (AD) requiring medical intervention
  4. Heterotopic ossification (HO) in the lower extremities resulting in ROM restrictions at the hips or knees
  5. Two or more pathological fractures in the last 48 months in a major weight bearing bone (femur or tibia) in the lower extremity
  6. Hip subluxation (x-rays will be obtained for individuals injured prior to 10 years of age)

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ekso treatment	Ekso	-

Primary Outcome Measures

Name	Time	Method
Number of Participants Adherent to Gait Training Progression Using Ekso	24 sessions	Participants were scheduled to utilize exoskeleton 3x per week for 8 weeks. The number of participants who completed this dose was tracked.

Secondary Outcome Measures

Name	Time	Method
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.	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.
Impact of Ekso Training on Spasticity	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.	The impact of Ekso training on muscle spasticity will be measured using the Modified Ashworth Scale (MAS)
Timed Up and Go (TUG)	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.	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.
Muscle Strength	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.	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.
Change in Bladder Function	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.	Evaluate the function of bowel and bladder as impacted by Ekso training using Modified International SCI Lower Urinary Tract Basic Data Set
Functional Abilities	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.	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.
Change in Bowel Function	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.	The effect of Ekso training on bowel function will be evaluated using Modified International SCI Bowel Function Basic Data Set
Quality of Life - Satisfaction of Life	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.	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.
Berg Balance Scale (BBS) - Balance	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.	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
10 Meter Walk Test - Gait Speed	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.	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.
Gait Progression	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.	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.

Trial Locations

Locations (9)

Institut Guttmann, Neurorehabilitation Hospital; 🇪🇸 Barcelona, Spain

Fundacion Lesionado Medular; 🇪🇸 Madrid, Spain

Clinical Department of Rehabilitation Medicine and Department of Medicine and Health Services; 🇸🇪 Linkoping, Sweden

Sinalenheten, Akademiska Sjukhuset; 🇸🇪 Uppsala, Sweden

Glostrup Hospital; 🇩🇰 Hornbaek, Denmark

Heliomare Revalidatie; 🇳🇱 Wijk aan Zee, Netherlands

Universitats-und Rehabilitationskliniken; 🇩🇪 Ulm, Germany

Swiss Paraplegic Center (SPZ); 🇨🇭 Nottwil, Switzerland

Sunnaas Sykehus HF; 🇳🇴 Oslo, Norway