Robotic Exoskeleton With Functional Electrical Stimulation in Acute Spinal Cord Injury

NCT04250688 | Unknown DMC FDA Device

• 1 other identifier: STU00202078
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to examine the effectiveness of mobility training using the Ekso robotic exoskeleton with functional electrical stimulation (FES) in persons affected by spinal cord injury; designated AIS classification A, B, C, or D. Traditionally, a person with an American Spinal Injury Association Impairment Scale (AIS) "A" injury, walking training is not performed. Even with AIS B, C and D injuries, although walking training may be appropriate, a person may not walk as much as needed to see an improvement due to environmental and staff limitations. The Ekso is a tool to give walking training to patients. The investigators aim to see if utilizing these technologies will affect recovery; specifically in sensation and muscle activity below the level of the injury as well as the ability to walk. The Ekso is a wearable, battery- operated exoskeleton that assists with walking. The Ekso has motors at the hip and knee joints to provide assistance that may be needed with walking. All motion is initiated either through body weight shifts or the use of an external controller. The Ekso robotic exoskeleton has been approved by the Food and Drug Administration as a powered exercise device for rehabilitative purposes such as this study. Currently, the Ekso is approved for people with spinal cord injuries from T4-L5 given bilateral arm strength of 4/5. With injuries from C7-T3, individuals must have AIS classification of D with bilateral arm strength of 4/5. For this study, it is possible that Ekso GT will be used outside of the current FDA approval if the injury level is C7-T3 and the person is classified as an AIS A, B or C injury level. Functional electrical stimulation (FES) will be used in conjunction with the robotic exoskeleton. FES involves using surface electrodes placed on the skin like a sticker over key leg muscles that will be stimulated in the normal walking pattern as a person walks in the device.

Conditions

Spinal Cord Injuries

Keywords

exoskeleton; ambulation; robotics; Functional electrical stimulation; acute spinal cord injuries

Outcome Measures

Primary Outcomes (2)

• Change in 6 Minute Walk Test from baseline in distance, rate of perceived exhaustion (RPE)

  The goal is to cover as much ground as possible over 6 minutes, the distance is measured with a measuring wheel. The minimum score is zero feet walked, there is no maximum score and the participant will be scored by how far they can walk in 6 minutes. The farther they walk, the better the score. The instructions are "Walk continuously if possible, but do not be concerned if you need to slow down or stop to rest." At the end of 6 minutes the participant is asked to rate their exertion level on a Borg Scale of 6 - 20 points.

  [Time Frame: Testing Day 1 - 3 and follow up testing Week 3 and Week 6.]

• Change in 10 meter walk test from baseline in gait speed

  Measure the time in second for and individual to walk 10 meters. The test is performed using a "flying start," patient walks 10 meters (33 ft) and the time is measured when the leading foot crosses the start line and the finish line. The instructions are: " Please walk this distance as fast as you safely can when I say go."

  Time Frame: Testing Day 1 - 3 and follow up testing Week 3 and Week 6

Secondary Outcomes (2)

• Magnetic resonance imaging lower extremity muscle volume

  Time Frame: Testing Day 1 - 3 and follow up testing Week 3 and Week 6

• Magnetic resonance imaging lower extremity fat infiltration

  Time Frame: Testing Day 1 - 3 and follow up testing Week 3 and Week 6

Study Arms (2)

Esko Bionics Suit + Functional Electrical Stimulation

EXPERIMENTAL

Device: Ekso Training with FES

Control

NO INTERVENTION

Interventions

Ekso Training with FES DEVICE

Esko Bionics Suit + Functional Electrical Stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medical clearance from attending inpatient physician
• Have an upper motor neuron spinal cord injury classified as ASIA A, B or C or D between C7-T11Subacute injury \<6 months at completion of study
• Be between 18-70 years of age.
• Be able to physically fit into the exoskeletal device.
• Be able to tolerate upright standing for a minimum of 30 minutes.
• Have joint range of motion within normal functional limits for ambulation.
• Have sufficient upper body strength to balance themself using the walker while wearing the exoskeleton.

You may not qualify if:

• Cervical level spinal cord injury above C6 or T12 and below
• Weight above 220 pounds
• Femur length above 47 cm or below 36 cm
• Joint contractures at the hip, knee, or ankle that limit normal range of motion (ROM) during ambulation;
• Cognitive and/or communication disability (e.g. due to brain injury);
• History of significant problems with skin break down or current skin break down that would prevent wearing the device;
• Any medical issue that precludes full weight bearing and ambulation (e.g. orthopedic injuries, pain, severe spasticity);
• History of severe osteoporosis or high risk of fractures. Medical clearance will be obtained for patients who are at risk of osteoporosis or fractures;
• Pregnancy;
• Inability to sign consent form indicating insufficient hand dexterity to utilize an assistive device.
• Cardiac Pacemaker;
• Metal implants in the areas of stimulation.

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• U.S. Department of Education: collaborator

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Arun Jayaraman, PT, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: January 31, 2020
• Study Start: January 1, 2016
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 7, 2023

Record last verified: 2023-03