Improving seated balance for wheelchair users with spinal cord injuries using an exoskeleton

"The Effects of Exoskeletal-Assisted Walking on Seated Balance Using the Indego™"

This study is testing if using an exoskeleton while walking can help wheelchair users with spinal cord injuries improve their balance while seated.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: James J. Peters Veterans Affairs Medical Center (fed)
• Locations: 1 site (The Bronx, New York)
• Trial ID: NCT04047992 on ClinicalTrials.gov

What this trial studies

This pilot study investigates the effects of exoskeleton-assisted walking (EAW) on seated balance in individuals with spinal cord injuries (SCI) who are wheelchair users. Participants will undergo 36 sessions of EAW training, which aims to enhance trunk muscle use and improve overall seated stability and independence in daily activities. The study will measure primary outcomes related to seated balance and secondary outcomes concerning body composition. The research is conducted at the James J. Peters Veterans Affairs Medical Center in Bronx, New York.

Who should consider this trial

Good fit: Ideal candidates are individuals with spinal cord injuries at the T4 level or below who are wheelchair users and have been injured for at least six months.

Not a fit: Patients with neurological injuries other than spinal cord injuries or those with severe concurrent medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved seated balance and independence for individuals with spinal cord injuries.

How similar studies have performed: Preliminary findings suggest that exoskeleton-assisted walking may improve balance and quality of life, indicating potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Traumatic or non-traumatic SCI ≥6 months duration of SCI;
2. Wheelchair-user for indoor and outdoor mobility;
3. Level and completeness of injury T4 and below with complete or incomplete SCI (ISNCSCI A to D);
4. Able to hold the crutches in hands with or without modifications; and
5. Able to provide informed consent.

Exclusion Criteria:

1. Diagnosis of neurological injury other than SCI;
2. Progressive condition that would be expected to result in changing neurological status;
3. Severe concurrent medical disease, illness or condition judged to be contraindicated by the Site Physician;
4. Anthropocentric incompatibility to be fitted with the device;
5. Traumatic or high impact lower extremity fracture within the past 2 years;
6. Fragility, minimal trauma or low impact fracture of the lower extremity since spinal cord injury;
7. Knee BMD \< 0.60 gm/cm2;
8. Total hip BMD T-scores \< -3.5;
9. Untreatable severe spasticity judged to be contraindicated by the Site Physician;
10. Flexion contracture that is incompatible with the device;
11. Limitations in ankle range of motion that cannot be adapted with an orthotic device (plantar flexion \> 00);
12. Fracture of the foot by x-ray and confirmed by CT;
13. Untreated or uncontrolled hypertension (systolic blood pressure \>140 mmHg; diastolic blood pressure \>90 mmHg);
14. Unresolved orthostatic hypotension (systolic blood pressure \<90 mmHg; diastolic blood pressure \<60 mmHg) as judged to be contraindicated by the Site Physician;
15. Current pressure ulcer of the arms, trunk, pelvic area, or lower extremities;
16. History of seizure;
17. Use of medications that significantly lower seizure threshold, such as tricyclic antidepressants, amphetamines, neuroleptics, dalfampridine, and bupropion;
18. History of stroke, brain tumor, brain abscess, or multiple sclerosis;
19. 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);
20. History of implanted brain/spine/nerve simulators, aneurysm clips, ferromagnetic metallic implants, or cardiac pacemaker/defibrillator;
21. Psychopathology documentation in the medical record or history that may conflict with study objectives; and/or
22. Pregnancy or women who plan to become pregnant during the study period.

Where this trial is running

The Bronx, New York

• James J. Peters VA Medical Center — The Bronx, New York, United States (RECRUITING)

Conditions: Spinal Cord Injuries