Bone Mineral Density Ekso Therapy Study

NCT03307954 | Completed

• 1 other identifier: STH19034
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (1)

• Number of valid data sets

  10 valid data sets (5 in each arm)

  2 years recruitment plus 3 months FU

Secondary Outcomes (5)

• Number of participants recruited

  2 years

• Number of participants with treatment-related adverse events according to the study protocol

  Up to 2 years plus 3 months FU

• Bone Mineral Density

  Week 0 and Week 12

• Bone Biochemistry

  Week 0 and Week 12

• Bone Biomarkers

  Week 0, Week 4, Week 8 and Week 12

Study Arms (2)

Ekso Therapy

EXPERIMENTAL

Up to 12 weeks of Ekso Therapy. Three sessions per week. One hour per session

Device: Ekso Therapy (Exoskeleton Suit)

Control

ACTIVE COMPARATOR

Up to 12 weeks of usual physiotherapy care. Three sessions per week. One hour per session.

Other: Usual Physiotherapy

Interventions

Ekso Therapy (Exoskeleton Suit) DEVICE

Ekso Therapy

Usual Physiotherapy OTHER

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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") )

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Northern General Hospital

Sheffield, S5 7AU, United Kingdom

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised controlled trial

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: October 12, 2017
• Study Start: October 6, 2016
• Primary Completion: September 14, 2017
• Study Completion: September 14, 2017
• Last Updated: April 13, 2018

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)