RECRUITING

Epidural Stimulation and Resistance Training After SCI

Conditions

Spinal Cord Injuries neuromodulation epidural simulation exoskeletal assisted walking resistance training rehabilitation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Epidural Stimulation and Resistance Training for Overground Locomotion After Spinal Cord Injury

Quick Facts

Study Start:2021-02-03

Study Completion:2025-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04782947

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. All participants will be between 18-60 years old, male or female, with traumatic motor complete SCI and level of injury of T10 and above, as determined by EMG testing and International Standards for Neurological Classification of SCI (ISNCSCI) exam. 2. Participants' knee extensors must respond to standard surface NMES procedures (frequency: 30 Hz; pulse duration:450 μs and amplitude of the current:200 mA) to ensure intact neural circuitry below the level of SCI. 3. All participants will undergo ISNCSCI examination for neurological level and function and only those with American Spinal Injury Classification (AIS A and B; i.e. motor deficit below the level of injury) will be included.	1. Diagnosis of neurological injury other than SCI, including cauda equina or distal conus injuries resulting in limb or sacral areflexia; 2. Unhealed fracture in either lower or upper extremities; 3. Severe scoliosis, hip knee range of motion (ROM) or flexion knee contractures preventing positioning in an exoskeleton or plantarflexion contracture greater than 20 degrees. 4. Untreated or uncontrolled hypertension defined as high resting blood pressure greater than 140/90 mmHg and severe orthostatic hypotension (drop greater than 20 mmHg compared to resting supine blood pressure) or incapable to maintain a sitting or EAW standing posture; 5. Other medical conditions including cardiovascular disease, uncontrolled type II DM, uncontrolled hypertension, and those on insulin, pressures sores stage 3 or greater, or symptomatic urinary tract infection; 6. Unable to fit in the device for any reason; 7. Taking anti-coagulants or anti-platelet agents, including aspirin if unable to be off this medication for medical reasons; 8. Implanted pacemakers and/or implanted defibrillator devices; 9. DXA T-Score less than -2.5. Scans done will include total body, dual hips and knees. Total hip BMD T-scores \< -3.5 and knee BMD scores of less than 0.6 g/cm2 68-71; 10. Functional upper and lower extremity ROM, strength, spasticity and skin integrity will also have assessed prior to enrollment in the program. The Modified Ashworth Scale will be used to ensure safety of the participants prior to engagement in the rehabilitation program. Participants with severe spasticity or limited ROM will be excluded from the trial. This is based on the Ekso® manufacturer's recommendations72; 11. Untreatable severe spasticity judged to be contraindicated by the site Physician; 12. Pressure ulcer of the trunk, pelvic area, or lower extremities of grade 3 or more; 13. Psychopathology documentation in the medical record or history that may conflict with study objectives; 14. Any condition that, in the judgment of the principal investigator or medical provider, precludes safe participation in the study and/or increases the risk of infection.

Inclusion Criteria

Exclusion Criteria

1. All participants will be between 18-60 years old, male or female, with traumatic motor complete SCI and level of injury of T10 and above, as determined by EMG testing and International Standards for Neurological Classification of SCI (ISNCSCI) exam.
2. Participants' knee extensors must respond to standard surface NMES procedures (frequency: 30 Hz; pulse duration:450 μs and amplitude of the current:200 mA) to ensure intact neural circuitry below the level of SCI.
3. All participants will undergo ISNCSCI examination for neurological level and function and only those with American Spinal Injury Classification (AIS A and B; i.e. motor deficit below the level of injury) will be included.

1. Diagnosis of neurological injury other than SCI, including cauda equina or distal conus injuries resulting in limb or sacral areflexia;
2. Unhealed fracture in either lower or upper extremities;
3. Severe scoliosis, hip knee range of motion (ROM) or flexion knee contractures preventing positioning in an exoskeleton or plantarflexion contracture greater than 20 degrees.
4. Untreated or uncontrolled hypertension defined as high resting blood pressure greater than 140/90 mmHg and severe orthostatic hypotension (drop greater than 20 mmHg compared to resting supine blood pressure) or incapable to maintain a sitting or EAW standing posture;
5. Other medical conditions including cardiovascular disease, uncontrolled type II DM, uncontrolled hypertension, and those on insulin, pressures sores stage 3 or greater, or symptomatic urinary tract infection;
6. Unable to fit in the device for any reason;
7. Taking anti-coagulants or anti-platelet agents, including aspirin if unable to be off this medication for medical reasons;
8. Implanted pacemakers and/or implanted defibrillator devices;
9. DXA T-Score less than -2.5. Scans done will include total body, dual hips and knees. Total hip BMD T-scores \< -3.5 and knee BMD scores of less than 0.6 g/cm2 68-71;
10. Functional upper and lower extremity ROM, strength, spasticity and skin integrity will also have assessed prior to enrollment in the program. The Modified Ashworth Scale will be used to ensure safety of the participants prior to engagement in the rehabilitation program. Participants with severe spasticity or limited ROM will be excluded from the trial. This is based on the Ekso® manufacturer's recommendations72;
11. Untreatable severe spasticity judged to be contraindicated by the site Physician;
12. Pressure ulcer of the trunk, pelvic area, or lower extremities of grade 3 or more;
13. Psychopathology documentation in the medical record or history that may conflict with study objectives;
14. Any condition that, in the judgment of the principal investigator or medical provider, precludes safe participation in the study and/or increases the risk of infection.

Contacts and Locations

Study Contact

Ashraf S Gorgey, PhD

CONTACT

804675500

ashraf.gorgey@va.gov

Robert Trainer, MD

CONTACT

8046755110

robert.trainer@va.gov

Principal Investigator

Ashraf S Gorgey, PhD

PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Study Locations (Sites)

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249

United States

Collaborators and Investigators

Sponsor: United States Department of Defense

Ashraf S Gorgey, PhD, PRINCIPAL_INVESTIGATOR, Virginia Commonwealth University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-03

Study Completion Date2025-08-31

Study Record Updates

Study Start Date2021-02-03

Study Completion Date2025-08-31

Terms related to this study

Keywords Provided by Researchers

neuromodulation
epidural simulation
exoskeletal assisted walking
resistance training
rehabilitation

Additional Relevant MeSH Terms

Spinal Cord Injuries