Status:
RECRUITING
Seated Balance Using the Indego™
Lead Sponsor:
James J. Peters Veterans Affairs Medical Center
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Exoskeleton-assisted walking (EAW) provides a new mobility option and appears to have potential therapeutic benefits for persons with SCI. However, present day technology is not sufficient to replace ...
Detailed Description
Introduction/Background: People with spinal cord injury (SCI) can lose partial to complete voluntary control of arm, trunk and leg muscles, resulting in an inability to sit with stability, stand and/o...
Eligibility Criteria
Inclusion
- Traumatic or non-traumatic SCI ≥6 months duration of SCI;
- Wheelchair-user for indoor and outdoor mobility;
- Level and completeness of injury T4 and below with complete or incomplete SCI (ISNCSCI A to D);
- Able to hold the crutches in hands with or without modifications; and
- Able to provide informed consent.
Exclusion
- Diagnosis of neurological injury other than SCI;
- Progressive condition that would be expected to result in changing neurological status;
- Severe concurrent medical disease, illness or condition judged to be contraindicated by the Site Physician;
- Anthropocentric incompatibility to be fitted with the device;
- Traumatic or high impact lower extremity fracture within the past 2 years;
- Fragility, minimal trauma or low impact fracture of the lower extremity since spinal cord injury;
- Knee BMD \< 0.60 gm/cm2;
- Total hip BMD T-scores \< -3.5;
- Untreatable severe spasticity judged to be contraindicated by the Site Physician;
- Flexion contracture that is incompatible with the device;
- Limitations in ankle range of motion that cannot be adapted with an orthotic device (plantar flexion \> 00);
- Fracture of the foot by x-ray and confirmed by CT;
- Untreated or uncontrolled hypertension (systolic blood pressure \>140 mmHg; diastolic blood pressure \>90 mmHg);
- Unresolved orthostatic hypotension (systolic blood pressure \<90 mmHg; diastolic blood pressure \<60 mmHg) as judged to be contraindicated by the Site Physician;
- Current pressure ulcer of the arms, trunk, pelvic area, or lower extremities;
- History of seizure;
- Use of medications that significantly lower seizure threshold, such as tricyclic antidepressants, amphetamines, neuroleptics, dalfampridine, and bupropion;
- History of stroke, brain tumor, brain abscess, or multiple sclerosis;
- History of moderate or severe head trauma (loss of consciousness for greater than one hour or evidence of brain contusion or hemorrhage or depressed skull fracture on prior imaging);
- History of implanted brain/spine/nerve simulators, aneurysm clips, ferromagnetic metallic implants, or cardiac pacemaker/defibrillator;
- Psychopathology documentation in the medical record or history that may conflict with study objectives; and/or
- Pregnancy or women who plan to become pregnant during the study period.
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04047992
Start Date
February 1 2018
End Date
December 31 2025
Last Update
May 14 2025
Active Locations (1)
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1
James J. Peters VA Medical Center
The Bronx, New York, United States, 10468