The WISE Trial - Walking Improvement for SCI With Exoskeleton

NCT02943915 | Completed Results FDA Device

• 1 other identifier: 105333
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 10

Brief 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

Conditions

Injuries, Spinal Cord

Keywords

Spinal Cord; Injury; Exoskeleton; Ekso; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

  Between baseline and 24 weeks

• Change in Distance Covered Over 6 Minutes From Baseline to 24 Weeks

  Baseline-24 weeks

• Change in Time Required to Complete Timed Up and Go (TUG) Test From Baseline to 24 Week Follow up

  Baseline and 24 weeks

• Number of Participants Who Experienced a Fall During Protocol

  Throughout 24 weeks

• Change in Berg Balance Scale Score From Baseline to 24 Weeks

  Baseline-24 weeks

Study Arms (3)

Group 1: Ekso GT Rehabilitation Therapy

EXPERIMENTAL

Participants in this group receive Ekso GT (gait training) PT therapy intervention 3 times per week for 12 weeks (36 sessions). Intervention: Ekso GT Rehabilitation therapy

Device: Ekso GT Rehabilitation Therapy

Group 2: Active controls - BWSTT Therapy

ACTIVE COMPARATOR

Participants in this group receive a matched number of sessions of standard gait training using body-weight supported treadmill training and overground training. Intervention: Body Weight Supported Treadmill Training

Device: Body Weight Supported (BWS) Treadmill Training

Group 3: Passive controls

NO INTERVENTION

Participants in this group continue with normal daily activities over 12 weeks.

Interventions

Ekso GT Rehabilitation Therapy DEVICE

Walking Improvement for Spinal Cord Injuries with Exoskeleton

Also known as: Exoskeleton

Group 1: Ekso GT Rehabilitation Therapy

Body Weight Supported (BWS) Treadmill Training DEVICE

Standard gait training using BWS PT and overground training

Also known as: Conventional Therapy

Group 2: Active controls - BWSTT Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Motor incomplete paraplegia or tetraplegia
• 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)
• Sufficient diaphragmatic strength such that respiration is not compromised with exercise.
• 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)
• AIS-C SCI \& AIS-D SCI, as determined by the International Standards for Neurological Classification of SCI (ISNCSCI)
• Ambulates at \<0.44 meters/second with or without physical assistance and assistance device
• WISCI ≥ 1
• yrs, inclusive
• No current or history of other neurological conditions
• Screened and cleared by a physician
• Involved in standing program or must be able to tolerate at least 15 min upright
• Weigh 220 pounds (100kg) or less
• Be able to fit into the Ekso device
• Approximately between 5'0" and 6'4" tall
• Standing hip width of approximately 18" or less

You may not qualify if:

• AIS-A SCI or AIS-B SCI
• Lower motor neuron injuries, as shown by absent reflexes during bilateral quadriceps and Achilles tendon taps
• \< 3 months since previous intensive gait training regimen
• Already walking at self-selected ambulation speeds of at least 0.44 meter/second with or without assistance
• Currently involved in another intervention study
• Concurrent neurological disease
• Hip flexion contracture greater than \~17°
• Knee flexion contracture greater than 12°
• Unable to achieve neutral ankle dorsiflexion with passive stretch (neutral with max 12° knee flexion)
• Leg length discrepancy
• Greater than 0.5" for upper leg
• Greater than 0.75" for lower leg
• Spinal instability
• Unresolved deep vein thrombosis
• Uncontrolled autonomic dysreflexia

Sponsors & Collaborators

• Ekso Bionics: lead
• Burke Medical Research Institute: collaborator

Study Sites (10)

Barrow Neurological Institute at St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

Gaylord Hospital

Wallingford, Connecticut, 06492, United States

Location

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

Marianjoy Rehabilitation Hospital

Wheaton, Illinois, 60187, United States

Location

Kennedy Kruger Institute

Baltimore, Maryland, 21211, United States

Location

Rehabilitation Institute of Michigan

Detroit, Michigan, 48201, United States

Location

Courage Kenny Research Center

Minneapolis, Minnesota, 55407, United States

Location

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

Burke Medical Research Institute

White Plains, New York, 10605, United States

Location

TIRR Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

Related Publications (7)

• 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.

  PMID: 27372363 BACKGROUND

• 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.

  PMID: 26736463 BACKGROUND

• 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.

  PMID: 26364280 BACKGROUND

• 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.

  PMID: 24845221 BACKGROUND

• 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.

  PMID: 26818847 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 24788068 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Wounds and Injuries

Interventions

Exoskeleton Device

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Results Point of Contact

• Title: Dylan Edwards
• Organization: Moss Rehabilitation Research Institute, Elkins Park, PA, USA

dylan.edwards@jefferson.edu

215-663-6554

Study Officials

• Dylan Edwards, PhD

  Burke Medical Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2016
• First Posted: October 25, 2016
• Study Start: September 1, 2016
• Primary Completion: September 10, 2019
• Study Completion: September 10, 2019
• Last Updated: October 31, 2023
• Results First Posted: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)