Feasibility Study to Investigate the Potential Reduction of Bone Mineral Density Loss in Spinal Cord Injured Patients Using Ekso Therapy
Abstract
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.
Conditions: Spinal Cord Injuries.
Primary outcome: Number of valid data sets.
Enrollment: 5 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 5 participants or records.
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