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Bone Mineral Density Ekso Therapy Study

NCT03307954 · Sheffield Teaching Hospitals NHS Foundation Trust · Updated 13 April 2018

What is being tested
Ekso Therapy (Exoskeleton Suit); Usual Physiotherapy
For
Spinal Cord Injuries
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years to 70 years. About 5 people. The full rules are on the registry page.
Where
United Kingdom
When
Starts or started 6 Oct 2016, ends 14 Sept 2017. Registered 12 Oct 2017.
Results
None posted yet.

In the researchers' words

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.
ClinicalTrials.gov, NCT03307954

Sites

  • Northern General HospitalSheffield, United Kingdom