The WISE Trial - Walking Improvement for SCI With Exoskeleton

Injuries, Spinal Cord Clinical Trial

— WISE  

Official title:

The WISE Trial - Walking Improvement for SCI With Exoskeleton

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02943915
• Other study ID #: 105333
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: September 10, 2019

Study information

• Verified date: October 2023
• Source: Ekso Bionics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized, controlled trial comparing exoskeleton gait training with standard gait training or no gait training in community-dwelling participants with chronic incomplete spinal cord injury

Description:

Community dwelling iSCI participants may improve clinical gait function by engaging in a gait training regimen, where robotic exoskeletons can readily deliver a precise dose and simultaneously reduce the physical stress imposed on therapists using conventional manually assisted stepping practice. Exoskeleton training is predicted to improve function in participants receiving usual care, but not superior to intensity-matched manual training. The rationale to implement exoskeleton robotics as preference in gait training is based on precision dosing, over-ground training, and reduced therapist burden for high repetition training.

The investigators aim to demonstrate that Ekso exoskeleton training can significantly improve gait speed in stable chronic, community-dwelling incomplete SCI (iSCI) participants. The objectives of this study are the following:

A. Primary Objective:

To demonstrate that a 12 week robotic gait training regimen can lead to a clinically meaningful improvement in independent gait speed on the 10 Meter Walk Test (10MWT) in community dwelling participants with chronic iSCI.

B. Secondary Objectives:

1. To examine the economic factors such as number of physical therapists/staff required during training.

2. To analyze the physical burden on therapists assisting and supervising during training.

3. To study the influence of factors that may modify the gait recovery in the chronic incomplete SCI population (demographic, clinical, functional, psychological, balance, etc.).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 10, 2019
• Est. primary completion date: September 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Motor incomplete paraplegia or tetraplegia

2. Neurological level of injury (NLI) C1- approximately T10 (inclusive, for upper motor neuron injuries only), as determined by the International Standards for Neurological Classification of SCI (ISNCSCI)

3. Sufficient diaphragmatic strength such that respiration is not compromised with exercise.

4. Sufficient upper extremity strength to use a front wheeled walker either by manual muscle testing (minimum triceps strength bilaterally of 3/5, shoulder abduction/adduction and flexion/extension 4/5)

5. AIS-C SCI & AIS-D SCI, as determined by the International Standards for Neurological Classification of SCI (ISNCSCI)

6. Ambulates at <0.44 meters/second with or without physical assistance and assistance device

7. WISCI = 1

8. 18 - 75 yrs, inclusive

9. No current or history of other neurological conditions

10. Screened and cleared by a physician

11. Involved in standing program or must be able to tolerate at least 15 min upright

12. Weigh 220 pounds (100kg) or less

13. Be able to fit into the Ekso device

14. Approximately between 5'0" and 6'4" tall

15. Standing hip width of approximately 18" or less

16. Have near normal range of motion in hips, knees and ankles

Exclusion Criteria:

1. AIS-A SCI or AIS-B SCI

2. Lower motor neuron injuries, as shown by absent reflexes during bilateral quadriceps and Achilles tendon taps

3. < 3 months since previous intensive gait training regimen

4. Already walking at self-selected ambulation speeds of at least 0.44 meter/second with or without assistance

5. Currently involved in another intervention study

6. Concurrent neurological disease

7. Hip flexion contracture greater than ~17°

8. Knee flexion contracture greater than 12°

9. Unable to achieve neutral ankle dorsiflexion with passive stretch (neutral with max 12° knee flexion)

10. Leg length discrepancy

1. Greater than 0.5" for upper leg

2. Greater than 0.75" for lower leg

11. Spinal instability

12. Unresolved deep vein thrombosis

13. Uncontrolled autonomic dysreflexia

14. Severe muscular or skeletal pain

15. Spasticity that prevents joint motion (severe stiffness or rigidity,) where both legs have a Modified Ashworth Score (MAS) score of 3 or higher for half or more of their proximal lower extremity muscles; proximal muscles include hip flexors/extensors/adductors and knee flexors/extensors.

16. Open skin ulcerations on buttocks or other body surfaces in contact with exoskeleton or harness

17. Pregnancy

18. Cognitive impairments - unable to follow 2 steps commands and communicate for pain or to stop session

19. Shoulder extension Range of Motion (ROM) < 50° excludes crutches during sit to stand or vice versa. (Walking with crutches permitted.)

20. Participant requires the assistance of more than one therapist to transfer safely.

21. Uncontrolled or severe orthostatic hypotension that limits standing tolerance; defined as sustained, symptomatic drops in systolic and diastolic blood pressure when moving from sitting to standing

22. Active heterotrophic ossification (HO), hip dysplasia or hip/knee axis abnormalities

23. Colostomy

24. History of long bone fractures since the SCI, secondary to osteoporosis

25. Unable to sustain current medication regimen

26. Any reason the physician may deem as harmful to the participant to enroll or continue in the study

Related Conditions & MeSH terms

• Injuries, Spinal Cord
• Spinal Cord Injuries
• Spinal Injuries

Intervention

Device:
• Ekso GT Rehabilitation Therapy
Walking Improvement for Spinal Cord Injuries with Exoskeleton
• Body Weight Supported (BWS) Treadmill Training
Standard gait training using BWS PT and overground training

Locations

Country	Name	City	State
United States	Kennedy Kruger Institute	Baltimore	Maryland
United States	Shirley Ryan AbilityLab	Chicago	Illinois
United States	Rehabilitation Institute of Michigan	Detroit	Michigan
United States	TIRR Memorial Hermann Hospital	Houston	Texas
United States	Courage Kenny Research Center	Minneapolis	Minnesota
United States	Barrow Neurological Institute at St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	Gaylord Hospital	Wallingford	Connecticut
United States	Kessler Foundation	West Orange	New Jersey
United States	Marianjoy Rehabilitation Hospital	Wheaton	Illinois
United States	Burke Medical Research Institute	White Plains	New York

Sponsors (2)

Lead Sponsor	Collaborator
Ekso Bionics	Burke Medical Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (7)

Forrest GF, Hutchinson K, Lorenz DJ, Buehner JJ, Vanhiel LR, Sisto SA, Basso DM. Are the 10 meter and 6 minute walk tests redundant in patients with spinal cord injury? PLoS One. 2014 May 1;9(5):e94108. doi: 10.1371/journal.pone.0094108. eCollection 2014. — View Citation

Gad PN, Gerasimenko YP, Zdunowski S, Sayenko D, Haakana P, Turner A, Lu D, Roy RR, Edgerton VR. Iron 'ElectriRx' man: Overground stepping in an exoskeleton combined with noninvasive spinal cord stimulation after paralysis. Annu Int Conf IEEE Eng Med Biol Soc. 2015 Aug;2015:1124-7. doi: 10.1109/EMBC.2015.7318563. — View Citation

Kolakowsky-Hayner SA, Crew J, Moran S, Shah A. Safety and feasibility of using the EksoTM bionic exoskeleton to aid ambulation after spinal cord injury. Spine. 2013 doi.org/10.4172/2165-7939.S4-003

Kozlowski AJ, Bryce TN, Dijkers MP. Time and Effort Required by Persons with Spinal Cord Injury to Learn to Use a Powered Exoskeleton for Assisted Walking. Top Spinal Cord Inj Rehabil. 2015 Spring;21(2):110-21. doi: 10.1310/sci2102-110. Epub 2015 Apr 12. — View Citation

Kressler J, Thomas CK, Field-Fote EC, Sanchez J, Widerstrom-Noga E, Cilien DC, Gant K, Ginnety K, Gonzalez H, Martinez A, Anderson KD, Nash MS. Understanding therapeutic benefits of overground bionic ambulation: exploratory case series in persons with chronic, complete spinal cord injury. Arch Phys Med Rehabil. 2014 Oct;95(10):1878-1887.e4. doi: 10.1016/j.apmr.2014.04.026. Epub 2014 May 17. — View Citation

Sale P, Russo EF, Russo M, Masiero S, Piccione F, Calabro RS, Filoni S. Effects on mobility training and de-adaptations in subjects with Spinal Cord Injury due to a Wearable Robot: a preliminary report. BMC Neurol. 2016 Jan 28;16:12. doi: 10.1186/s12883-016-0536-0. — View Citation

Stampacchia G, Rustici A, Bigazzi S, Gerini A, Tombini T, Mazzoleni S. Walking with a powered robotic exoskeleton: Subjective experience, spasticity and pain in spinal cord injured persons. NeuroRehabilitation. 2016 Jun 27;39(2):277-83. doi: 10.3233/NRE-161358. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Gait Speed From Baseline to 12 Weeks Using 10 Meter Walk Test (10MWT)	The mean change in gait speed demonstrated during the 10MWT after 12 weeks of training and compared between groups. Positive values indicate improvement in gait speed (faster) from baseline to 12 weeks. Negative values indicate a reduction in gait speed (slower) from baseline to 12 weeks.	Baseline and 12 Weeks
Secondary	Number of Participants Who Met the Minimal Clinically Important Difference of 0.15m/s in Gait Speed Per 10 Meter Walk Test (10MWT) From Baseline to 24 Weeks	Number of participants who achieve the Minimal Clinically Important Difference (MCID) of 0.15 m/s during the 10MWT when comparing between baseline gait speed and gait speed at 24 weeks.	Between baseline and 24 weeks
Secondary	Change in Distance Covered Over 6 Minutes From Baseline to 24 Weeks	6 minute walk test (6MWT) completed at baseline and 24 weeks. Change assessed. Positive values indicate an increase in distance was able to be walked at 24 weeks versus at baseline. Negative values indicate a decrease in distance was walked at 24 weeks versus at baseline.	Baseline-24 weeks
Secondary	Change in Time Required to Complete Timed Up and Go (TUG) Test From Baseline to 24 Week Follow up	Examined balance and walking in participants at baseline and follow up at 24 weeks. Positive values indicate an improvement of time (less time) required to complete task at 24 week follow up versus at baseline. Negative values indicate a decline, more time required to complete task at follow up versus baseline.	Baseline and 24 weeks
Secondary	Number of Participants Who Experienced a Fall During Protocol	At each training session, assessed if participant had experienced any falls. Count is number of participants who reported that yes, they did experience a fall.	Throughout 24 weeks
Secondary	Change in Berg Balance Scale Score From Baseline to 24 Weeks	Measurement of static and dynamic sitting and standing balance completed at baseline and at 24 weeks. Berg balance scale is a 14 item test with each item scored from 0-4. Possible scores range from 0-56. Higher scores indicate a lower risk of falls and better balance. Positive numbers indicate an improvement in Berg balance scale (scored out of 56), meaning that the participant scored higher at 24 weeks than at baseline. Negative values indicate a decline in performance of the Berg balance scale (scored out of 56), meaning that the participant scored lower at 24 weeks than at baseline.	Baseline-24 weeks