Epidural Stimulation and Resistance Training After SCI

Part of paid clinical trials in Richmond, Virginia.

Sponsor
United States Department of Defense
Study ID
NCT04782947
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Exoskeletal assisted walking — DEVICE
    Exoskeletal assisted walking includes the use of robotic suit to train participant to walk with different level of assistance.
  • Epidural Stimulation — DEVICE
    lumbo-sacral epidural simulation at the beginning of the study.
  • Resistance Training — PROCEDURE
    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.
  • delayed-ES — DEVICE
    lumbo-sacral epidural simulation starting 6 months after the beginning of the study.
  • no-Resistance training — PROCEDURE
    The participants will perform 24 weeks of passive movement or passive stretching from seated position.

Study Details

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.

Key Dates

Start date
Feb 3, 2021
Status verified
Dec 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: EAW+ES+RT
    The exoskeletal assisted walking with epidural simulation and resistance training (EAW+ES+RT) group will undergo 6 months of supervised EAW +ES (3X per week) followed by additional 6 months of EAW+ES (3X per week) and progressive RT twice weekly (2X per week). In the EAW+ES+RT group, RT will be administered for 12 weeks using an open kinematic chain approach of applying surface NMES and ankle weights followed by 12 weeks twice weekly of gradually using the implanted ES to perform sit-to-stand approach (i.e. using their body weights to load the exercising muscles in a closed kinematic fashion).
  • Experimental: EAW+ delayed-ES +no-RT
    The control exoskeletal assisted walking with delayed epidural simulation and without resistance training (EAW+ delayed-ES +no-RT) group will enroll in 6 months of EAW without ES (3X per week) and then this will be followed by additional 6 months (3x per week) of EAW+ES (i.e., delayed entry approach) without conducting RT and will perform either passive movement of passive stretching (2X per week).

Primary Outcome Measure

Change in 10-meter over ground walking-speed [ Time Frame: Baseline to 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hunter Holmes McGuire VA Medical CenterRichmondVirginia23249
Ashraf S Gorgey, MPT,PhD, FACSM
[email protected]
804-675-5000
Lance Goetz, MD
[email protected]
804-675-5000
Ashraf S Gorgey, MPT, PhD, FACSM (PRINCIPAL_INVESTIGATOR)
Robert Trainer, MD (SUB_INVESTIGATOR)
Lance Goetz, MD (SUB_INVESTIGATOR)
Timothy Lavis, MD (SUB_INVESTIGATOR)
Adam Klausner, MD (SUB_INVESTIGATOR)
Carrie Peterson, PhD (SUB_INVESTIGATOR)
Denise Lester, MD (SUB_INVESTIGATOR)

Find similar trials in Richmond, VA

By research site
Hunter Holmes McGuire VA Medical Center· Richmond, VA

Related Studies