None listed
Conditions
Brief summary
For those with Multiple Sclerosis (MS), weight-bearing exercise can pose many challenges for both patients and their therapists. Due to physical demands and safety issues, those with severe mobility impairment are often denied the opportunity for weight bearing, task specific training. This type of training is essential if the recovery of functional abilities such as independent transfers and mobility are to be achieved. Advances in robotic technologies have led to the development of wearable lower body exoskeletons. These can be used to assist sit to stand, weight bearing activities and gait. This research team is in the fortunate position to be provided access to an exoskeleton (HELLEN) to research its applicability in people with MS, having already commenced a sister trial with participants with Acquired Brain Injury. This device has the potential to assist therapists to increase patient opportunities for weight bearing training at higher intensity and dosage to maximise their potential for recovery. This is ground breaking research with no previously published literature on this topic with this device. Our aim is to examine the potential health benefits and feasibility of using a lower limb exoskeleton as an adjunct tool for neurorehabilitation in those with severe mobility impairment due to MS. This is a Phase I, wait-list controlled trial with 20 participants. Baseline measurements will be taken on enrolment into the study followed by a 12week waitlist period. They will then receive 12 weeks of intervention, provided by a physiotherapist (Nicola Postol). This will involve two 1 hour sessions of individualised upright weight-bearing exercise facilitated by HELLEN, per week. Participants will be provided with a home exercise program, updated throughout the trial as required. Reassessment will occur after 6 and 12 weeks of intervention and after 12 weeks follow-up and will comprise of a battery of impairment, function and quality of life measures.
Interventions
HELLEN is a REX Bionics Exoskeleton which in lay terms is like a pair of robotic legs, which the user is strapped into. The straps are at the shins, thighs, abdomen, and around the hips. The user is fitted to the device whilst the device is in sitting. The user will transfer in their usual way into the device. A hoist is available if this is necessary.
Participants will initially be screened using standard questionnaires and assessment tools. Leg measurements will be taken so that the robotic d
HELLEN is a REX Bionics Exoskeleton which in lay terms is like a pair of robotic legs, which the user is strapped into. The straps are at the shins, thighs, abdomen, and around the hips. The user is fitted to the device whilst the device is in sitting. The user will transfer in their usual way into the device. A hoist is available if this is necessary. Participants will initially be screened using standard questionnaires and assessment tools. Leg measurements will be taken so that the robotic device can be individually fitted. They will then be put on a 12 week wait list and reassess prior to the commencement of therapy. 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 an experienced physiotherapist, including upright weight-bearing exercise facilitated by HELLEN (a REX Bionics Robotic Exoskeleton - "Hunter's Robotic Exoskeleton for Lower Limb Exercise and Rehabilitation") as tolerated by the patient. This may 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 practice. Participants will also be provided with a home exercise program relevant to their treatment, which will be updated throughout the trial as required. This will include exercises relevant to each individual maximising their potential in therapy e.g. standing tolerance at a bench with upper limb exercises, squats, transfer practise etc. It will not involve exercise in the device. Frequency of the home exercise program will be 5 days per week, for 20-30 mins per day, and monitored by checking the completed box on attendance records throughout the therapy period of the trial. Measurements will be retaken after 6 weeks of the therapy, after 12 weeks of therapy, and a further 12 weeks after the completion of the program
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 MS 2. Resident of the Hunter region over the age of 18 years 3. Severe mobility impairment whereby the participant is reliant on a mobility aid or other people for upright activities (Scores >6 on the Expanded Disability Status Scale)
Exclusion criteria
1. Weight >100kg or <40kg; height >6'4" or <4'8" (criteria set by the REX Bionics) 2. Pregnancy 3. Unstable or severe cardiac or respiratory conditions 4. Recent fractures in lower limbs/pelvis/spine 5. Significant cognitive impairment (<19 on MoCA) 6. Any medical condition which limits the ability to exercise in an upright position
Outcome results
None listed