Epidural Stimulation and Resistance Training After SCI

Summary

Spinal cord injury (SCI) is a devastating health problem for tens of thousands of military personnel, Veterans and civilians annually. Many persons with SCI must use a wheelchair for their entire life. A new scientific breakthrough called "lumbosacral epidural stimulation" or "ES" can help people with SCI to stand, step and even walk again. At present, for ES to work, people must train with a specialized treadmill that requires several other qualified personnel to train them, which makes it hard for many people with SCI to benefit from this technology. On the other hand, there are wearable "robot suits" that can be used with ES, which would make it easier to use. Our research team has already used this "ES Robot Suit" for 3 months in one person with tetraplegia and showed remarkable improvements in motor control. Furthermore, the investigators are aiming to enhance overground motor recovery by adding 6 months of resistance training (RT). The addition of RT will likely to enhance muscle quality as indicated by increasing lean mass, peak torque and increase sensory flux to the central nervous system. Other additional benefits may include improvement in cardiovascular profile and bladder functions. The specific objectives of the current proposal are to compare the impact of EAW+ES following improving lower extremity muscle quality compared to those who will only undergo EAW+ ES without conducting RT on motor recovery, cardio-metabolic health and bladder control in persons with complete SCI. At the conclusion of the current proposal, the work will be readily available for translation into clinical setting to serve Veterans and Civilian survivors with SCI.

Conditions

• Spinal Cord Injuries

Interventions

DEVICE

Exoskeletal assisted walking

Exoskeletal assisted walking includes the use of robotic suit to train participant to walk with different level of assistance.

DEVICE

Epidural Stimulation

lumbo-sacral epidural simulation at the beginning of the study.

PROCEDURE

Resistance Training

Using two forms of resistance training to increase muscle size. The first form includes seated leg extension exercise for 12 weeks followed by a second form that includes sit-to-stand exercise using participant's body weight.

DEVICE

delayed-ES

lumbo-sacral epidural simulation starting 6 months after the beginning of the study.

PROCEDURE

no-Resistance training

The participants will perform 24 weeks of passive movement or passive stretching from seated position.

Sponsors & Collaborators

• Central Virginia VA Health Care System

  collaborator UNKNOWN

• United States Department of Defense

  lead FED

Principal Investigators

• Ashraf S Gorgey, PhD · Virginia Commonwealth University

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-02-03

Primary Completion

2026-05-31

Completion

2026-05-31

FDA Device

Yes

Countries

• United States

Study Locations