Clinical trial NCT02132702: Performance Attributes and User Progression While Using Ekso
Official title: Performance Attributes and User Progression While Using Ekso Robotic Exoskeleton in an Eight Week, Over Ground, Locomotor Program in Individuals With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Lead sponsor: Ekso Bionics
Sponsor class: INDUSTRY
Collaborators: name: Glostrup University Hospital, Copenhagen
First posted: 2014-05-07
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Adherent to Gait Training Progression Using Ekso
timeFrame: 24 sessions
Secondary outcomes:
measure: Cardiovascular Effect
timeFrame: 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.
measure: Impact of Ekso Training on Spasticity
timeFrame: 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.
measure: Timed Up and Go (TUG)
timeFrame: 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.
measure: Muscle Strength
timeFrame: 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.
measure: Change in Bladder Function
timeFrame: 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.
measure: Functional Abilities
timeFrame: 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.
measure: Change in Bowel Function
timeFrame: 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.
measure: Quality of Life - Satisfaction of Life
timeFrame: 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.
measure: Berg Balance Scale (BBS) - Balance
timeFrame: 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.
measure: 10 Meter Walk Test - Gait Speed
timeFrame: 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.
measure: Gait Progression
timeFrame: 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.
Other outcomes:
Locations:
city: Hornbaek
country: Denmark
facility: Glostrup Hospital
city: Ulm
country: Germany
facility: Universitats-und Rehabilitationskliniken
city: Wijk aan Zee
country: Netherlands
facility: Heliomare Revalidatie
city: Oslo
country: Norway
facility: Sunnaas Sykehus HF
city: Barcelona
country: Spain
facility: Institut Guttmann, Neurorehabilitation Hospital
city: Madrid
country: Spain
facility: Fundacion Lesionado Medular
city: Linkoping
country: Sweden
facility: Clinical Department of Rehabilitation Medicine and Department of Medicine and Health Services
city: Uppsala
country: Sweden
facility: Sinalenheten, Akademiska Sjukhuset
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Center (SPZ)
Study officials:
affiliation: Glostrup University Hospital, Copenhagen
name: Fin Biering-Sorensen, MD
role: PRINCIPAL_INVESTIGATOR
References: