NCT05615766 Assessment of a Robotic Exoskeleton for Upper Limb Rehabilitation
| NCT ID | NCT05615766 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Liverpool |
| Condition | Spinal Cord Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 9 participants |
| Start Date | 2022-09-01 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 9 participants in total. It began in 2022-09-01 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Heba Lakany, PhD
PRINCIPAL INVESTIGATOR
University of Liverpool
Frequently Asked Questions
Who can join the NCT05615766 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spinal Cord Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05615766 currently recruiting?
Yes, NCT05615766 is actively recruiting participants. Contact the research team at heba.lakany@liverpool.ac.uk for enrollment information.
Where is the NCT05615766 trial being conducted?
This trial is being conducted at London, United Kingdom, Oswestry, United Kingdom.
Who is sponsoring the NCT05615766 clinical trial?
NCT05615766 is sponsored by University of Liverpool. The principal investigator is Heba Lakany, PhD at University of Liverpool. The trial plans to enroll 9 participants.