Last updated: February 23, 2024
Sponsor: United States Department of Defense
Overall Status: Active - Recruiting
Phase
2/3
Condition
Spinal Cord Injuries
Treatment
Resistance Training
no-Resistance training
Epidural Stimulation
Clinical Study ID
NCT04782947
SC190107
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- All participants will be between 18-60 years old, male or female, with traumatic motorcomplete SCI and level of injury of T10 and above, as determined by EMG testing andInternational Standards for Neurological Classification of SCI (ISNCSCI) exam.
- Participants' knee extensors must respond to standard surface NMES procedures (frequency: 30 Hz; pulse duration:450 μs and amplitude of the current:200 mA) toensure intact neural circuitry below the level of SCI.
- All participants will undergo ISNCSCI examination for neurological level and functionand only those with American Spinal Injury Classification (AIS A and B; i.e. motordeficit below the level of injury) will be included.
Exclusion
Exclusion Criteria:
- Diagnosis of neurological injury other than SCI, including cauda equina or distalconus injuries resulting in limb or sacral areflexia;
- Unhealed fracture in either lower or upper extremities;
- Severe scoliosis, hip knee range of motion (ROM) or flexion knee contracturespreventing positioning in an exoskeleton or plantarflexion contracture greater than 20degrees.
- Untreated or uncontrolled hypertension defined as high resting blood pressure greaterthan 140/90 mmHg and severe orthostatic hypotension (drop greater than 20 mmHgcompared to resting supine blood pressure) or incapable to maintain a sitting or EAWstanding posture;
- 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;
- Unable to fit in the device for any reason;
- Taking anti-coagulants or anti-platelet agents, including aspirin if unable to be offthis medication for medical reasons;
- Implanted pacemakers and/or implanted defibrillator devices;
- 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;
- Functional upper and lower extremity ROM, strength, spasticity and skin integrity willalso have assessed prior to enrollment in the program. The Modified Ashworth Scalewill be used to ensure safety of the participants prior to engagement in therehabilitation program. Participants with severe spasticity or limited ROM will beexcluded from the trial. This is based on the Ekso® manufacturer's recommendations72;
- Untreatable severe spasticity judged to be contraindicated by the site Physician;
- Pressure ulcer of the trunk, pelvic area, or lower extremities of grade 3 or more;
- Psychopathology documentation in the medical record or history that may conflict withstudy objectives;
- 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.
Study Design
Total Participants: 20
Treatment Group(s): 5
Primary Treatment: Resistance Training
Phase: 2/3
Study Start date:
February 03, 2021
Estimated Completion Date:
August 31, 2025
Study Description
Connect with a study center
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia 23249
United StatesActive - Recruiting
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