Ekso Bone Mineral Density Study Version 1.0
Research type
Research Study
Full title
Feasibility Study to Investigate the Potential Reduction of Bone Mineral Density Loss in Spinal Cord Injured Patients Using Ekso Therapy.
IRAS ID
207203
Contact name
Kidangalil Mathew
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 3 months, 1 days
Research summary
Effects of Ekso Therapy on the Bone Mineral Density of Spinal Cord Injured (SCI) Patients
Bone density loss is very common in patients following SCI and can occur rapidly after injury. Loss of bone density makes the lower limbs weak and patients can become more susceptible to bone breaks even after a minor fall. In order to prevent or reduce bone density loss occurring, Ekso therapy will be investigated. Ekso is a revolutionary powered exoskeleton device, which is strapped on to SCI patients to enable them to stand and walk. It is reported to be a good form of exercise allowing patients to stretch and is claimed to be beneficial for muscle strength and bone health. However, to date there is limited clinical evidence.
This is a single centre randomised controlled study which will take place at the Sheffield Princess Royal Spinal Injuries Centre. The study will provide some initial results on whether Ekso therapy reduces or prevents the bone density loss of SCI patients. Twenty inpatients aged 18-70 years with incomplete SCI at C2 level (neck) or below, or complete SCI at C7 level or below will be recruited. Patients will be split into two groups at random. Group 1 will receive Ekso therapy 3 times per week for 12 weeks. Group 2 will receive standing therapy 3 times per week for 12 weeks. Both groups will also receive usual physiotherapy care. Before, during and after the 12 weeks of therapy, the patient’s bone biochemistry, bone health and bone mineral density will be assessed.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
16/YH/0284
Date of REC Opinion
26 Jul 2016
REC opinion
Favourable Opinion