SHS_543102 CHAJ XNON 16011

Exoskeletal Neurorehabilitation using HAL Exoskeleton Technology

Demonstrate presence of improvement of mobility, coordination skills, balance, and functional patient reported outcomes using validated outcomes measurements in patients who have sustained neurologic decline along with evaluation of central nervous system mechanisms involved in biofeedback responses.

Inclusion Criteria

1. Spinal cord injury patients with ASIA A through D functional status with thoracic and lumbar levels of paralysis are primary enrollment targets.
2. Cervical spinal cord injuries patients with injuries below the C6 level can be included after initial institutional experience with the thoracic and lumbar levels of injuries has been gained at the study site.
3. Patients with CVA, MS and other neurodegenerative disorders such as Parkinson’s disease that have significant gait impairment will be considered on a case-by-case basis depending upon stability of their neurologic status and their ability to function in a neuromuscularly controlled robotic suit at the discretion of the Principal Investigator.
4. Patients on active medications for spasticity must be on a stable dose for at least 3 months prior to study entry.
5. Signed informed consent prior to initiation of any study-specific procedure or treatment. The patient or the patient’s legally authorized representative (where acceptable) must be able to provide written informed consent (ICF) and understand the potential risks and benefits of study enrollment and treatment.

Exclusion Criteria

1. Contractures.
2. Patients under 18 years of age.
3. Patients unable to follow-up.
4. Patients unable to speak English.
5. Prisoners and individuals in other forms of involuntary confinement.
6. Patients unable to complete program and/or attend required follow-up visits.
7. Females of childbearing potential must have a negative pregnancy test.
8. High grade spinal cord level spasticity.
9. Unstable spasticity with ongoing dose and intervention changes within 90 days of planned HAL therapy.
10. High grade osteoporosis with presence of spontaneous fractures.
11. Coronary heart disease.
12. Implanted pacemakers or other implanted neural stimulators or pumps.
13. Acute pulmonary embolism.
14. Open decubital ulcers.
15. Unhealed fractures.
16. Body weight over 220 pounds.
17. Trochanter-to-trochanter width >37 cm interdistance using caliper measurement.
Pilot/Feasibility
Neurosciences, All Other
Spine
Jens Chapman, M.D.
Caryl Tongco
  • Swedish Medical Center