Spinal Cord Injuries
Conditions
Brief summary
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.
Interventions
DEVICEExperimental: Device Intervention
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.
Sponsors
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
The Queen Elizabeth National Spinal Injuries Unit, Scotland
Stoke Mandeville Spinal Research
University of Liverpool
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18+ years. * The levels of C5 C6 Asia C/D would provide individuals with elbow and hand impairment and potentially functional shoulder movements. C7, C8 individuals could also benefit from the hand component of the device. * Some gross shoulder movement at start of the trial to enable changes at the elbow/hand, to have the greatest potential for functional change. * Preservation of hand sensation as base for motor restoration. * Some sitting balance would give the best opportunity for the arm to be released for functional upper limb activity. * EMG (muscle activity) evidence of active finger flexion, extension and elbow flexion extension Grade 1-2. * Minimal or No community functional use of upper limb at start of trial. * Spasticity MAS 1-3/5.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spinal Cord Independence Measure version III (SCIM III) | Change from baseline (week 1) at 6 weeks | assesses performance in activities of daily living and mobility for individuals with spinal cord injury |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP). | Change from baseline (week 1) at 6 weeks and 12 weeks | 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. |
| The modified Ashworth scale | Change from baseline (week 1) at 6 weeks and 12 weeks | Ashworth scale is the most universally accepted clinical spasticity assessment tool used to measure the increase of muscle tone. |
| Range of Motion | Change from baseline (week 1) at 6 weeks and 12 weeks | to assess the capability of a joint to go through its complete spectrum of movements |
| Canadian Occupational Performance Measure (COPM) | Change from baseline (week 1) at 6 weeks and 12 weeks | COPM assesses the patient's perceived occupational performance in the areas of selfcare, productivity, and leisure |
Other
| Measure | Time frame | Description |
|---|---|---|
| The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) | Change from baseline (week 1) at 6 weeks and 12 weeks | The QUEST 2.0 evaluates a patient's satisfaction with various assistive technologies. |
Countries
United Kingdom
Contacts
Primary ContactHeba Lakany, PhD
Backup ContactKaren Wilding
Outcome results
None listed