Using a robotic exoskeleton for upper limb rehabilitation in spinal cord injury patients
EXO4UL- Assessment of a Robotic Exoskeleton for Upper Limb Rehabilitation of Spinal Cord Injured Patients
This study is testing a robotic device to help people with spinal cord injuries improve their arm movement and independence during rehabilitation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 9 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Liverpool Academic / other |
| Locations | 2 sites (London and 1 other locations) |
| Trial ID | NCT05615766 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a commercial robotic orthosis designed for upper limb rehabilitation in patients with spinal cord injuries. Conducted in two neuro-rehabilitation centers in the UK, the trial will involve nine tetraplegic inpatients who will participate in a twelve-week rehabilitation program. Each patient will attend three to four sessions per week, focusing on improving their upper limb function through the use of the robotic device alongside their usual care. The goal is to empower patients to self-manage their rehabilitation and enhance their independence.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with specific spinal cord injury levels (C5-C8) and some gross shoulder movement.
Not a fit: Patients with severe upper limb impairment or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the independence and quality of life for patients with spinal cord injuries.
How similar studies have performed: While this approach is relatively novel in the NHS, similar studies in other settings have shown promise in using robotic exoskeletons for rehabilitation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
London and 1 other locations
- Royal National Orthopaedic Hospital (Stanmore) — London, United Kingdom (Recruiting)
- The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust — Oswestry, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Heba Lakany, PhD — University of Liverpool
- Study coordinator: Heba Lakany, PhD
- Email: heba.lakany@liverpool.ac.uk
- Phone: +447737353181
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.