Performance Attributes and User Progression While Using Ekso

NCT ID: NCT02132702

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2017-01-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ekso treatment

Group Type: EXPERIMENTAL

Ekso

Intervention Type: DEVICE

Interventions

Ekso

Intervention Type: DEVICE

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role: collaborator

Ekso Bionics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fin Biering-Sorensen, MD

Role: PRINCIPAL_INVESTIGATOR

Glostrup University Hospital, Copenhagen

Locations

Glostrup Hospital

Hornbæk, , Denmark

Universitats-und Rehabilitationskliniken

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

Countries

Denmark; Germany; Netherlands; Norway; Spain; Sweden; Switzerland

Other Identifiers

H-1-2013-082

Identifier Type: -

Identifier Source: org_study_id