Performance Attributes and User Progression While Using Ekso

Spinal Cord Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02132702
• Other study ID #: H-1-2013-082
• Status: Completed
• Phase: N/A
• First received: May 2, 2014
• Last updated: February 12, 2018
• Start date: August 2014
• Est. completion date: January 2017

Study information

• Verified date: February 2018
• Source: Ekso Bionics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

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 24?" 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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Device:
• Ekso

Locations

Country	Name	City	State
Denmark	Glostrup Hospital	Hornbaek
Germany	Universitats-und Rehabilitationskliniken	Ulm
Netherlands	Heliomare Revalidatie	Wijk aan Zee
Norway	Sunnaas Sykehus HF	Oslo
Spain	Institut Guttmann, Neurorehabilitation Hospital	Barcelona
Spain	Fundacion Lesionado Medular	Madrid
Sweden	Clinical Department of Rehabilitation Medicine and Department of Medicine and Health Services	Linkoping
Sweden	Sinalenheten, Akademiska Sjukhuset	Uppsala
Switzerland	Swiss Paraplegic Center (SPZ)	Nottwil

Sponsors (2)

Lead Sponsor	Collaborator
Ekso Bionics	Glostrup University Hospital, Copenhagen

Countries where clinical trial is conducted

Denmark,  Germany,  Netherlands,  Norway,  Spain,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants able to complete gait training progression using Ekso	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. The user will be trained with 1 person assisting without an overhead tether in multiple modes and levels of assist while maintaining safety. The following will indicate completion of training: number of Ekso sessions completed, ability to train in ProStep on or before session #24 without a tether, number of steps in device, time spent walking in device, and the duration of training sessions in each mode.	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	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.
Secondary	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.
Secondary	Mobility 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 Timed Up and Go (TUG) to monitor mobility.	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	Impact of Ekso Training on Strength	The muscle strength of users will be analyzed to see if there is any gain in strength due to the Ekso training program.	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	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)	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	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	The Quality of Life change due to Ekso training will be evaluated using the International SCI Quality of Life Basic Data Sheet	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	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.	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 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.	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.	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.