Rehabilitation robotics has the potential to facilitate rehabilitation at home and empower people with spinal injuries to self-manage increasing their independence and improving their quality of life. The objective of this study is to assess for the first time in the NHS the efficacy of a commercial robotic orthosis for upper limb rehabilitation in patients with spinal cord injury. The device is produced by Myomo (myomo.com) which is an American company. We will be assessing the wearable robotic orthosis also known as robotic exoskeleton in two different neuro-rehabilitation centres: National Spinal injuries Unit in Glasgow (Scotland) and The Robert Jones and Agnus Hunt Orthopaedic Hospital in Oswestry (England). The study will involve nine spinal cord injured tetraplegic inpatients in total. Patients will follow a twelve-week rehabilitation programme with three to four sessions per week in addition to their usual care and rehabilitation. Each session lasts for approximately 45 minutes. Participants arm function, range of motion, spasticity level will be measured before, half-way and at the end of the programme to assess change in these and other parameters. Training will focus on the dominant arm of the patient and compared to the other arm at every assessment stage. We shall evaluate therapists' and patients' satisfaction with the commercial device in addition to assessing various clinical measures to evaluate the efficacy of using the robotic orthosis in rehabilitation and recovery of arm function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
SINGLE
Enrollment
9
The robotic rehabilitation programme using the MARK from Myomo (myomo.com) for the intervention group will last for 12 weeks with up to four sessions of rehabilitation per week, i.e. total of 48 sessions. Spinal cord injured inpatients in the study will have this intervention on their dominant arm in addition to the traditional rehabilitation programme assigned and standard care.
Royal National Orthopaedic Hospital (Stanmore)
London, United Kingdom
RECRUITINGThe Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Oswestry, United Kingdom
RECRUITINGSpinal Cord Independence Measure version III (SCIM III)
assesses performance in activities of daily living and mobility for individuals with spinal cord injury
Time frame: Change from baseline (week 1) at 6 weeks
Spinal Cord Independence Measure version III (SCIM III)
assesses performance in activities of daily living and mobility for individuals with spinal cord injury
Time frame: Change from baseline (week 1) at 12 weeks
The Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP).
The GRASSP is a clinical impairment measure for the upper limb for use after tetraplegia. The measure includes three domains which are important in describing hand function.
Time frame: Change from baseline (week 1) at 6 weeks and 12 weeks
The modified Ashworth scale
Ashworth scale is the most universally accepted clinical spasticity assessment tool used to measure the increase of muscle tone.
Time frame: Change from baseline (week 1) at 6 weeks and 12 weeks
Range of Motion
to assess the capability of a joint to go through its complete spectrum of movements
Time frame: Change from baseline (week 1) at 6 weeks and 12 weeks
Canadian Occupational Performance Measure (COPM)
COPM assesses the patient's perceived occupational performance in the areas of selfcare, productivity, and leisure
Time frame: Change from baseline (week 1) at 6 weeks and 12 weeks
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