Actively Recruiting
Seated Balance Using the Indego™
Led by James J. Peters Veterans Affairs Medical Center · Updated on 2025-05-14
20
Participants Needed
1
Research Sites
412 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 the wheelchair. During EAW, users stand upright, maintain static and dynamic balance by actively and passively stimulating trunk and lower limb muscles in a manner not challenged during wheelchair use. Preliminary results in our laboratory suggest that the indirect balance challenges and postural perturbations that result during EAW training transfer to better seated balance control, resulting in more independence during seated activities. The purpose of this pilot study is to determine the effects of EAW training on various measures of seated balance (primary outcomes) and body composition (secondary outcomes). Twenty people with SCI (T4 and below) who are wheelchair users for mobility and cannot walk independently will be recruited. The participants will receive 36 sessions of EAW training in 12 weeks. The outcomes will be evaluated pre (baseline) and post (24 and 36 sessions). If EAW devices can be demonstrated to help people with SCI have better seated balance, in addition to the other potential benefits that are being investigated elsewhere, then exoskeletons may have the possibility to be more readily accepted in the clinical, home environments, and by the insurance companies.
CONDITIONS
Official Title
Seated Balance Using the Indego™
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Traumatic or non-traumatic spinal cord injury with duration of at least 6 months
- Use a wheelchair for indoor and outdoor mobility
- Level and completeness of injury T4 and below, complete or incomplete (ISNCSCI A to D)
- Able to hold crutches in hands with or without modifications
- Able to provide informed consent
You will not qualify if you...
- Diagnosis of neurological injury other than spinal cord injury
- Progressive condition expected to change neurological status
- Severe medical disease or condition contraindicated by the physician
- Incompatibility to fit with the exoskeleton device
- Traumatic or high impact lower extremity fracture within past 2 years
- Fragility, minimal trauma, or low impact lower extremity fracture since spinal cord injury
- Knee bone mineral density less than 0.60 gm/cm2
- Total hip bone mineral density T-score less than -3.5
- Untreatable severe spasticity contraindicated by the physician
- Flexion contracture incompatible with the device
- Limited ankle range of motion that cannot be adapted with orthotic device (plantar flexion > 0 degrees)
- Foot fracture confirmed by X-ray and CT
- Untreated or uncontrolled hypertension (systolic >140 mmHg or diastolic >90 mmHg)
- Unresolved orthostatic hypotension (systolic <90 mmHg or diastolic <60 mmHg) contraindicated by physician
- Current pressure ulcers on arms, trunk, pelvic area, or lower extremities
- History of seizure
- Use of medications that lower seizure threshold
- History of stroke, brain tumor, brain abscess, or multiple sclerosis
- History of moderate or severe head trauma
- History of implanted brain/spine/nerve stimulators, aneurysm clips, ferromagnetic metallic implants, or cardiac pacemaker/defibrillator
- Psychopathology that may conflict with study objectives
- Pregnancy or planning to become pregnant during the study period
AI-Screening
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Trial Site Locations
Total: 1 location
1
James J. Peters VA Medical Center
The Bronx, New York, United States, 10468
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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