Bone Mineral Density Ekso Therapy Study
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries
Study type: Interventional

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 have been reported and rates of loss are maximal over the first two years. As
      a consequence, there is an increased risk of fragility fractures particularly of the lower
      limbs including an increased risk of hip fracture. Lower limb fragility fractures affect up
      to 35% of patients following SCI. These fractures are associated with considerable morbidity
      and an increase in mortality.

      This single centre UK study will determine if it is feasible to carry out a randomised
      controlled BMD study in the acute SCI patient population. The study will compare the BMD of
      patients who receive Ekso Therapy (powered exoskeleton device) verse patients who receive
      usual physiotherapy alone (control group). It will address patient recruitment rates and
      reasons for withdrawal from the study and highlight any practicality issues with study
      conduct. It will also provide preliminary data on the effects of Ekso Therapy on BMD,
      biochemistry and bone turnover markers.
    

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 loss with large decreases in bone
      mineral density (BMD) below the level of the lesion (Frey-Rindova et al., 2000). Decreases in
      BMD of ~2% per month from the lower limbs have been reported and rates of loss are maximal
      over the first two years (Jiang et al., 2005). Bone loss is associated with increased bone
      resorption and remodelling imbalance which is thought to be due to the combined effects of
      immobility together with neurogenic effects. As a consequence, there is an increased risk of
      fragility fractures particularly of the lower limbs including an increased risk of hip
      fracture. Lower limb fragility fractures affect up to 35% of patients following SCI. These
      fractures are associated with considerable morbidity and an increase in mortality.

      BMD is conventionally measured using dual-energy x-ray absorptiometry (DXA). This technique
      enables measurement of bone mineral content, projected area and areal BMD at the lumbar spine
      and proximal femur. DXA does not allow differentiation between cortical and trabecular bone
      and does not have the ability to examine microstructural change. High resolution peripheral
      quantitative computed tomography (HR-pQCT) is a novel technique which enables changes in
      trabecular and cortical microstructure to be evaluated. Using HR-pQCT it is possible to
      detect changes in surrogate measures of bone strength in response to loss of weight bearing
      activity over just 6 weeks (Kazakia et al, 2014).

      To date, there is no established intervention which has been demonstrated to prevent or
      reverse bone loss and fractures in this clinical setting. Small studies have suggested that
      anti-resorptive agents including bisphosphonates (Bryson et al., 2009) and denosumab (Gifre
      et al., 2015) have potential to protect against bone loss following SCI. Physical therapy
      using vibration was ineffective (Dudley-Javoroski et al., 2015) as was an ambulation
      programme undertaken late in the management of SCI (Needham-Shropshire et al., 1997). Once
      bone loss has occurred, it appears to be at best only partially reversible on recovery of
      lower limb function. It has been postulated that weight-bearing activity on its own
      (Dionyssiotis et al., 2015) or perhaps in combination with anti-resorptive treatment has the
      potential to preserve or improve bone health following SCI.

      In 2014, a new therapy service called 'Ekso Therapy' was introduced at the Sheffield Princess
      Royal Spinal Injuries Centre. Ekso is a revolutionary powered exoskeleton device, which is
      strapped on to patients with a SCI to enable them to stand and walk. The device is
      manufactured by Ekso Bionics and is CE marked. It has been reported to be a good form of
      exercise allowing patients to stretch, and is claimed to be beneficial for muscle strength,
      bone health, bowel and bladder function and circulation and has a positive psychological
      impact. None of these claims have been investigated or proven in large clinical trials.

      This single centre UK study will therefore determine if it is feasible to carry out a
      randomised controlled bone study in the acute SCI patient population using the Ekso device.
      Investigators will compare the BMD of acute SCI patients before and after they receive a
      programme of Ekso Therapy alongside their usual physiotherapy and compare it to patients who
      receive standing therapy with usual physiotherapy alone (control group).

      It will address patient recruitment rates and reasons for withdrawal from the study and
      highlight any practicality issues with study conduct. It will also provide preliminary data
      on the effects of Ekso Therapy on bone mineral density, biochemistry and bone turnover
      markers.
    

Intervention name(s): Ekso Therapy (Exoskeleton Suit); Usual Physiotherapy
Intervention type(s): Device; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised controlled trial
Masking: None (Open Label)
Primary purpose: Treatment