Performance Attributes and User Progression While Using Ekso

NCT02132702 | Completed Results

• 1 other identifier: H-1-2013-082
• Study Type: interventional
• Target: 60
• Locations: 7 countries
• Sites: 9

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.

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (1)

Ekso treatment

EXPERIMENTAL

Device: Ekso

Interventions

Ekso DEVICE

Ekso treatment

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Hip extension greater than or equal to 5 degrees
• Knee extension greater than or equal to 5 degrees
• 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

You may not qualify if:

• 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:
• Spinal instability (or spinal orthotic unless cleared by physician)
• Acute deep vein thrombosis (DVT) with activity restrictions
• Severe, recurrent autonomic dysreflexia (AD) requiring medical intervention
• Heterotopic ossification (HO) in the lower extremities resulting in ROM restrictions at the hips or knees
• Two or more pathological fractures in the last 48 months in a major weight bearing bone (femur or tibia) in the lower extremity
• 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

Sponsors & Collaborators

• Ekso Bionics: lead
• Glostrup University Hospital, Copenhagen: collaborator

Study Sites (9)

Glostrup Hospital

Hornbæk, Denmark

Location

Universitats-und Rehabilitationskliniken

Ulm, Germany

Location

Heliomare Revalidatie

Wijk aan Zee, Netherlands

Location

Sunnaas Sykehus HF

Oslo, Norway

Location

Institut Guttmann, Neurorehabilitation Hospital

Barcelona, Spain

Location

Fundacion Lesionado Medular

Madrid, Spain

Location

Clinical Department of Rehabilitation Medicine and Department of Medicine and Health Services

Linköping, Sweden

Location

Sinalenheten, Akademiska Sjukhuset

Uppsala, Sweden

Location

Swiss Paraplegic Center (SPZ)

Nottwil, Switzerland

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Carsten Bach Baunsgaard
• Organization: Clinic for Spinal Cord Injuries, Rigshospitalet, University of Copenhagen

carsten.bach.baunsgaard@regionh.dk

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Study Officials

• Fin Biering-Sorensen, MD

  Glostrup University Hospital, Copenhagen

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2014
• First Posted: May 7, 2014
• Study Start: August 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-07

Locations

NO (1); DK (1); NL (1); DE (1); SE (2); CH (1); ES (2)