The effect of a robotic walking intervention on individuals with spinal cord injury
- Conditions
- Nervous System DiseasesSpinal Cord Injury
- Registration Number
- PACTR201608001647143
- Lead Sponsor
- niversity of Cape Town
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 48
¿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
oStanding height: 157cm ¿ 188cm
oMaximum hip width: 42cm
oUpper leg length (Femur): 51cm to 61.4cm
oLower Leg length (Tibia): 48cm to 63.4cm
oMaximum weight: 100 kilograms
oHip extension greater than or equal to 5 degrees
oKnee extension less than or equal to 12 degrees
oAnkle 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
¿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:
oHeart or respiratory comorbidity
oSpinal instability (or spinal orthotic unless cleared by physician)
oAcute deep vein thrombosis (DVT) with activity restrictions
oStoma bag
oSevere, recurrent autonomic dysreflexia (AD) requiring medical intervention
oHeterotopic ossification (HO) in the lower extremities resulting in ROM restrictions at the hips or knees
oTwo or more pathological fractures in the last 48 months in a major weight bearing bone (femur or tibia) in the lower extremity
oHip 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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method euromuscular Changes;Psychological Changes;Secondary Complications
- Secondary Outcome Measures
Name Time Method