None listed
Conditions
Brief summary
Each year in Australia 300-400 new cases of Spinal Cord Injury (SCI) are reported with prevalence predicted to continue to increase with population growth and improved medical care. The most obvious consequence of SCI is paralysis however it also has an impact on many other body functions as well, including social, financial and psychological implications. Most long-term wheelchair users adopt a sedentary lifestyle with prolonged sitting and limited opportunities to engage in physical activities. As a result, many people with SCI experience progressive physical deconditioning and its associated multifactorial health consequences such as diabetes and hyperlipidaemia. This contributes to loss of functional ability and the increased risk of cardiovascular morbidity and mortality. Physiotherapy during rehabilitation focuses on goals related to improving functional ability such as walking, transferring, propelling a wheelchair, balance and upper limb usage. This involves the management of weakness, reduced range of movement, decreased fitness, pain, and respiratory compromise. For those patients with paralysis there is often great difficulty in assisting them to stand and support their body weight. It places a substantial burden on therapists who must assist the patient into standing whilst trying to facilitate exercise and prevent falls. Therefore, these patients are often denied opportunity for the intense, functional therapy this is required to produce positive outcomes. The development of robotic exoskeletons has the potential to overcome the current limitations to therapy. These overground exoskeletons provide motorised assistance at the hips, knees and ankles via motors and coordinate movements at these joints to produce or assist with standing, upright exercises, and walking. They can be used to make gait training, transfer training, and balance training, easier and provide a safe opportunity for intensive practice related to standing and strenuous exercise. There are many different types of robotic exoskeletons currently available but there is no published evidence investigating the patient benefits of using the REX Bionics exoskeleton (HELLEN) as a rehabilitation tool. We aim to examine the potential benefits of using this device as an adjunct tool for rehabilitation in people with SCI. This data will be compared to data being collected in adjacent trials in Stroke and Multiple Sclerosis, currently being conducted by this research team.
Interventions
Participants are assisted to transfer into the device, which is basically a pair of robot pants, and are then strapped into it. The intervention will involve 2 sessions of exercise therapy per week for 12 weeks. Each session will be 1 hour duration and will consist of individualised therapy, prescribed and administered by a Rex Robotic accredited physiotherapist. This will entail upright weight-bearing exercise facilitated by the device (HELLEN) as tolerated by the participant and will be a com
Participants are assisted to transfer into the device, which is basically a pair of robot pants, and are then strapped into it. The intervention will involve 2 sessions of exercise therapy per week for 12 weeks. Each session will be 1 hour duration and will consist of individualised therapy, prescribed and administered by a Rex Robotic accredited physiotherapist. This will entail upright weight-bearing exercise facilitated by the device (HELLEN) as tolerated by the participant and will be a combination of sit to stand practise, standing tolerance, weight shift, trunk control exercises, stepping practise, side stepping, squats, upper limb exercises and gait practise. These exercises will be individually tailored to meet the abilities and needs of the client. Participants will also be provided with a short home exercise program (not in HELLEN) relevant to their treatment (requiring no more than half an hour per day), which will be reviewed and amended as required monthly during the therapy phase. Patients will be asked to self report participation in their home exercise program. Interventions will only be progressed according to the individual participants’ abilities as deemed appropriate by the administering physiotherapist. Interventions will be modified or ceased if, in communication with the participant, the researchers deem that this is necessary.
Sponsors
University of Newcastle
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of traumatic or non-traumatic SCI at least 3 months prior to enrolment 2. Resident of the Hunter region 3. 18 years of age or older 4. Discharged from inpatient rehabilitation programs 5. Severe mobility impairment and reliant on wheelchair, mobility aid, or the assistance of others for standing activities ( scores < /=5 on the mobility assessment of SCIM-III)
Exclusion criteria
1. Weight between 40 kg and 100kg; height between 4’8” and 6'4" (as per the recommendations of the robotic manufacturer) 2. Pregnancy 3. Unstable or severe cardiac or respiratory compromise 4. Nonconsolidated fractures in lower limbs/pelvis/spine or diagnosed severe osteopenia ( t-score less than or equal to -2.5) 5. Significant cognitive impairment (Montreal Cognitive Assessment Score of less than 19) 6. Any medical condition which limits the ability to exercise in an upright position. This includes: pressure sores in contact with the exoskeleton, lower limb heterotrophic ossification, severe lower limb muscle contracture, spinal instability, acute deep vein thrombosis, recurrent attacks of autonomic dysreflexia requiring medical intervention, hip subluxation, a history of pathological fractures in the lower limbs in the last 2 years)
Outcome results
None listed