Assessment of a Robotic Exoskeleton for Upper Limb Rehabilitation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Experimental: Device Intervention.
- Who it may be relevant to
- Registry conditions: Spinal Cord Injuries. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
EXO4UL- Assessment of a Robotic Exoskeleton for Upper Limb Rehabilitation of Spinal Cord Injured Patients
Overview
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
- Device Experimental: 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.
Primary outcome measures
- Spinal Cord Independence Measure version III (SCIM III) [Time frame: Change from baseline (week 1) at 6 weeks]
- Spinal Cord Independence Measure version III (SCIM III) [Time frame: Change from baseline (week 1) at 12 weeks]
Secondary outcome measures (4)
- The Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP). [Time frame: Change from baseline (week 1) at 6 weeks and 12 weeks]
- The modified Ashworth scale [Time frame: Change from baseline (week 1) at 6 weeks and 12 weeks]
- Range of Motion [Time frame: Change from baseline (week 1) at 6 weeks and 12 weeks]
- Canadian Occupational Performance Measure (COPM) [Time frame: Change from baseline (week 1) at 6 weeks and 12 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Single blind
- Primary purpose
- Device feasibility
Study locations
United Kingdom · 2 centers
- Royal National Orthopaedic Hospital (Stanmore) — London
- The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust — Oswestry
Identifiers
NCT: NCT05615766 · IRAS312522