The WISE Trial - Walking Improvement for SCI With Exoskeleton

Sponsor

Ekso Bionics (Industry)

Overall Status

Completed

CT.gov ID

NCT02943915

Collaborator

Burke Medical Research Institute (Other)

Enrollment

Locations

Arms

36.3

Duration (Months)

4.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Injuries, Spinal Cord	Device: Ekso GT Rehabilitation Therapy Device: Body Weight Supported (BWS) Treadmill Training	N/A

Detailed 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:

To examine the economic factors such as number of physical therapists/staff required during training.
To analyze the physical burden on therapists assisting and supervising during training.
To study the influence of factors that may modify the gait recovery in the chronic incomplete SCI population (demographic, clinical, functional, psychological, balance, etc.).

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The WISE Trial - Walking Improvement for SCI With Exoskeleton

Study Start Date :

Sep 1, 2016

Actual Primary Completion Date :

Sep 10, 2019

Actual Study Completion Date :

Sep 10, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1: Ekso GT Rehabilitation Therapy 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 Walking Improvement for Spinal Cord Injuries with Exoskeleton Other Names: Exoskeleton
Active Comparator: Group 2: Active controls - BWSTT Therapy 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 Standard gait training using BWS PT and overground training Other Names: Conventional Therapy
No Intervention: Group 3: Passive controls Participants in this group continue with normal daily activities over 12 weeks.

Arm

Intervention/Treatment

Experimental: Group 1: Ekso GT Rehabilitation Therapy

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

Walking Improvement for Spinal Cord Injuries with Exoskeleton

Other Names:

Exoskeleton

Active Comparator: Group 2: Active controls - BWSTT Therapy

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

Standard gait training using BWS PT and overground training

Other Names:

Conventional Therapy

No Intervention: Group 3: Passive controls

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

Outcome Measures

Primary Outcome Measures

10 Meter Walk Test (10MWT) [Baseline and 12 Weeks]
The mean increase in gait speed demonstrated during the 10MWT after 12 weeks of training and compared between groups.

Secondary Outcome Measures

10 Meter Walk Test (10MWT) [Baseline and evaluations week 6,12, 24]
10MWT: Number of participants who achieve the Minimal Clinically Important Difference (MCID) of 0.15 m/s 21 during the 10MWT. Number of participants who transition from exercise or household ambulation (defined as a walking speed of < 0.44 meters/second) to limited community or full community ambulation (> 0.44 meter/second) during the 10MWT. Time point of recovery at which participants reach the MCID and/or community ambulation speeds of > 0.44 meters/second.
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Exam - Full Exam for Classification [Baseline and week 12]
Number of participants who convert from American Spinal Cord Injury Association (AIS) C to AIS D.
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Exam - Full Exam for Scoring [Baseline and week 12]
Motor and sensory scores
Participant Quality of Life [Baseline and evaluations week 6, 12, 24]
International SCI Quality of Life Basic Data Set. Depression scores using the Epidemiological Studies Depression Scale (CES-D 10).
Numeric Pain Rating Scale [Weeks 1-12]
Numeric Pain Rating Scale for self-reported neuropathic pain upon resting and during gait training.
Therapist Outcomes [Weeks 1-12]
Number of therapists/staff required for each active group as well as set-up/donning time for cost effectiveness of the two active therapies.
6 Minute Walk Test (6MWT) [Baseline, Evaluations week 6, 12, and 24]
Measurement of endurance, level of assistance and assistive devices needed and distance walked
Timed Up and Go (TUG) [Baseline, Evaluations week 6, 12, and 24]
Test of basic mobility skills. Balance during sit-to-stand, walking, turning, and stand-to-sit.
Walking Index for Spinal Cord Injury II (WISCI-II) [Baseline, Evaluations week 6, 12, and 24]
Measurement of the ability of an individual to complete a locomotor task in a standardized environment. Score for need of assistive devices.
Spinal Cord Injury Functional Ambulatory Index (SCI-FAI) [Baseline, Evaluations week 6, 12, and 24]
Quality assessment of gait pattern
Spinal Cord Independence Measure (SCIM-III, Mobility subscale) [Baseline, Evaluations week 6, 12, and 24]
Mobility subscale for ability to perform transfers and walking different distances.
Body Mass Index (BMI) [Baseline, Evaluations week 6, 12, and 24]
General health measure.
Upper and Lower Extremity Muscle Strength [Baseline, Evaluations week 6 and 24]
As measured by physical therapist for muscle strength.
Spinal Cord Assessment Tool for Spastic Reflexes (SCATS) Modified Ashworth Scale [Baseline, Evaluations week 6, 12, and 24]
Spasticity measurement.
Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET) [Baseline, Evaluations week 6, 12, 24]
Participant reported spasticity measurement.
Numeric Rating of Spasticity [Baseline and weekly assessments for 12 weeks]
Participant reported spasticity measurement.
Heart Rate [Baseline, Weekly training sessions 1 - 12, Evaluations week 6, 12 and 24]
Physiological outcomes: heart rate
Participant Borg Rating of Perceived Exertion Scale (Borg) [Baseline and weekly assessments for 12 weeks, Evaluations week 6, 12 and 24]
Self-reported perceived exertion.
Modified International SCI Bowel Function Basic Data Set [Baseline, Evaluations week 6, 12 and 24]
Participant assessment of bowel function
Modified International SCI Lower Urinary Tract Basic Data Set [Baseline, Evaluations week 6, 12 and 24]
Participant lower urinary tract assessment and incidence of urinary track infections.
Incidence of Pressure Ulcers [Baseline, each training session 1 through 36.]
Skin integrity check.
Incidence of Falls [Each training session 1 through 36, Evaluations week 6, 12 and 24]
Assessed at each visit via participant report.
Incidence of Hospitalization and/or Unexpected Physician Visits [Each training session 1 through 36, Evaluations week 6, 12 and 24]
Assessed at each visit via participant report.
Therapist Borg Rating of Perceived Exertion Scale (Borg) [Weeks 1 through 12]
Self-reported perceived exertion.
Therapist National Aeronautics and Space Administration (NASA) Task Load Index [Weeks 1 through 12]
Self-reported work load assessment.
Participant National Aeronautics and Space Administration (NASA) Task Load Index [Weeks 1 through 12]
Self-reported work load assessment.
Video Assessment of Physical Therapist Posture [Week 1 and Week 12]
Independent assessment of shoulder, neck, and trunk posture.
Therapist Report of Pain and/or Injury [Up to Week 12]
Therapist self-reported questionnaire.
Blood Pressure [Baseline, Evaluations week 6, 12 and 24]
Physiological outcomes: blood pressure
Gait Quality [Baseline, Evaluations week 6, 12 and 24]
GAITRite for temporospatial gait parameters and symmetry
Berg Balance Scale [Baseline, Evaluations week 6, 12 and 24]
Measurement of static and dynamic sitting and standing balance

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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
18 - 75 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
Have near normal range of motion in hips, knees and ankles

Exclusion Criteria:

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
Severe muscular or skeletal pain
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.
Open skin ulcerations on buttocks or other body surfaces in contact with exoskeleton or harness
Pregnancy
Cognitive impairments - unable to follow 2 steps commands and communicate for pain or to stop session
Shoulder extension Range of Motion (ROM) < 50° excludes crutches during sit to stand or vice versa. (Walking with crutches permitted.)
Participant requires the assistance of more than one therapist to transfer safely.
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
Active heterotrophic ossification (HO), hip dysplasia or hip/knee axis abnormalities
Colostomy
History of long bone fractures since the SCI, secondary to osteoporosis
Unable to sustain current medication regimen
Any reason the physician may deem as harmful to the participant to enroll or continue in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Barrow Neurological Institute at St. Joseph's Hospital and Medical Center	Phoenix	Arizona	United States	85013
2	Gaylord Hospital	Wallingford	Connecticut	United States	06492
3	Shirley Ryan AbilityLab	Chicago	Illinois	United States	60611
4	Marianjoy Rehabilitation Hospital	Wheaton	Illinois	United States	60187
5	Kennedy Kruger Institute	Baltimore	Maryland	United States	21211
6	Rehabilitation Institute of Michigan	Detroit	Michigan	United States	48201
7	Courage Kenny Research Center	Minneapolis	Minnesota	United States	55407
8	Kessler Foundation	West Orange	New Jersey	United States	07052
9	Burke Medical Research Institute	White Plains	New York	United States	10605
10	TIRR Memorial Hermann Hospital	Houston	Texas	United States	77030