Nervous System Diseases Spinal Cord Injury
Conditions
Interventions
Robotic Locomotor Training
Activity Based Training
Sponsors
University of Cape Town
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ¿ Male or female individuals with a SCI (traumatic) ¿ 18 through to 65 years old ¿ English speaking (Does not need to be 1st language but must be fluent) ¿ Chronic (>1yr) spinal cord injury ¿ Motor/Sensory incomplete (AIS B, C, D), with a neurological level of injury (NLI) between C1-C8 as determined by the International Standards for Neurological Classification of SCI (ISNCSCI) ¿ Reliant upon a wheelchair as their primary mode of mobility ¿ Sufficient anthropometrics and range of motion (ROM) to achieve a normal, reciprocal gait pattern within the EksoTM suit o Standing height: 157cm ¿ 188cm o Maximum hip width: 42cm o Upper leg length (Femur): 51cm to 61.4cm o Lower Leg length (Tibia): 48cm to 63.4cm o Maximum weight: 100 kilograms o Hip extension greater than or equal to 5 degrees o Knee extension less than or equal to 12 degrees o Ankle dorsiflexion greater than or equal to 0 degrees ¿ Sufficient upper extremity (UE) strength to use a front wheeled walker (FWW) either by manual muscle testing (MMT) (minimum triceps strength bilaterally of 3/5, shoulder abduction/adduction and flexion/extension 4/5) and/or by functional standing test with FWW. Participants with impaired hand function may use cuff grips. ¿ Demonstrate adequate trunk stability and upper extremity strength to utilize EksoTM bionic walking suit as evidenced by the ability to complete a level (or near level) surface wheelchair to mat transfer with minimal assistance. ¿ Medically stable and cleared by a physician for full weight bearing locomotor training including 15 minute standing frame trial to assess standing tolerance. ¿ Severe osteoporosis: DEXA Z score < -2 of the hip or lumbar spine
Exclusion criteria
Exclusion criteria: ¿ Non-traumatic SCI ¿ Have trained in a robotic exoskeleton in the past ¿ Performing any other form of locomotor training ¿ Clinically Depressed (Beck Depression Inventory) ¿ Any medical issue that in the opinion of the investigator precludes full weight bearing locomotor training including but not limited to: o Heart or respiratory comorbidity o Spinal instability (or spinal orthotic unless cleared by physician) o Acute deep vein thrombosis (DVT) with activity restrictions o Stoma bag o Severe, recurrent autonomic dysreflexia (AD) requiring medical intervention o Heterotopic ossification (HO) in the lower extremities resulting in ROM restrictions at the hips or knees o Two or more pathological fractures in the last 48 months in a major weight bearing bone (femur or tibia) in the lower extremity o Hip subluxation (x-rays will be obtained for individuals injured prior to 10 years of age. ¿ Any medical issue that in the opinion of the investigator would affect participant safety either due to cognitive deficits/impulsivity, intolerance to mild exercise or other factors ¿ Any issue that in the opinion of the investigator would confound results such as a concurrent neurological injury or disorder (other than SCI) ¿ Modified Ashworth Scale (MAS) = 4 in any of the lower extremity joints (i.e scored a 4 on the scale (indicating rigidity in the joint) when testing joint movements in lower extremities (hip flexion/extension, knee flexion/extension, ankle dorsi/plantar flexion) ¿ Skin integrity issues in areas that contact the device (including abdominal ostomies) or that would prohibit sitting ¿ Pregnancy ¿ Z scores outside of recommended range (<-2)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neuromuscular Changes;Psychological Changes;Secondary Complications | — |
Countries
South Africa
Contacts
Public ContactRobert Evans
PhD Student
Outcome results
None listed