Status:
COMPLETED
Bone Mineral Density Ekso Therapy Study
Lead Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Spinal cord injury (SCI) leads to rapid and profound bone loss with large decreases in bone mineral density (BMD) below the level of the lesion. Decreases in BMD of \~2% per month from the lower limbs...
Detailed Description
There are an estimated 40,000 people living with a Spinal Cord Injury (SCI) in the UK alone (http://www.apparelyzed.com/statistics.html). Spinal cord injury (SCI) leads to rapid and profound bone los...
Eligibility Criteria
Inclusion
- Aged 18-70 years old inclusive
- Traumatic and non-traumatic incomplete tetraplegic or paraplegic patient following acute SCI injury
- Be able to provide written informed consent or verbal consent in the presence of an independent witness
- Stable medical condition
- Independently transfer from a wheelchair to a regular chair ideally by completing a "lift and shift" manoeuvre or a standing pivot transfer.
- Currently undertaking an active standing programme with a standing frame i.e. Oswestry Standing Frame, for longer than 15 minutes for inpatients
- Sufficient upper limb function to be able to grasp and release objects in the hands with or without use of 'Active hands'.
- Sufficient range of movement to tolerate sit to stand and normal walking.
- Sufficient upper extremity strength and sitting balance to assist with balance in standing with a frame and or crutches.
- Sufficient lower extremity bone density to stand in standing frame and walk in traditional orthotics
- Motor complete paralysis (Asia A) C7 or below
- Incomplete motor paralysis (Asia C) C2 or below
- Weigh 220 pounds (100 kilograms) or less
- Between 5'2" and 6'4" (157 to 188 cm) tall
- Standing hip width of 17.5" or less.
Exclusion
- Aged less than 18 years old
- Lack the mental capacity to consent
- Ventilated patients
- Significant upper or lower limb contractures / spasticity
- Currently participating in another research study which may have an impact on the study or patient safety and well-being.
- Range of motion restrictions that would prevent clients from achieving a normal, reciprocal gait pattern, or would restrict clients completing normal sit-to-stand or stand-to-sit transitions
- Spinal instability
- Unresolved deep vein thrombosis (DVT)
- Decreased standing tolerance due to orthostatic hypotension
- Significant osteoporosis that prevents safe standing or may increase the risk of fracture caused by standing or walking
- Previous lower limb fractures less than 6 months ago.
- Uncontrolled spasticity
- Uncontrolled Autonomic Dysreflexia (AD)
- Insufficient upper extremity strength to assist with balance with frame or crutches
- Leg length discrepancy above recommended values. (Upper leg length discrepancy greater than half an inch (\> .5") or lower leg discrepancy greater than three-quarters of an inch (\>.75") )
- Skin integrity issues on contact surfaces of the device or on surfaces that would prohibit sitting
- Cognitive impairments resulting in motor planning or impulsivity concerns
- Pregnancy
- Ability to mobilise further than 10m on the parallel bars or with use of a walking aid.
Key Trial Info
Start Date :
October 6 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 14 2017
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03307954
Start Date
October 6 2016
End Date
September 14 2017
Last Update
April 13 2018
Active Locations (1)
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1
Northern General Hospital
Sheffield, United Kingdom, S5 7AU