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Assessment of a Robotic Exoskeleton for Upper Limb Rehabilitation

Sponsor: University of Liverpool

NCT ID: NCT05615766

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Experimental: Device Intervention (device)
How long the study runs
Study runs about 42 months (dates as stated)
About the drug or intervention
Experimental: Device Intervention — device: 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.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
9
Started
2022-09-01
Last checked
2025-04

Plain English Summary

What is this study?

  • • Testing a new treatment for spinal cord injuries
  • • NA - 9 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with spinal cord injuries

Where?

  • • London - Royal National Orthopaedic Hospital (Stanmore)
  • • Oswestry - The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Spinal Cord Injuries

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Age 18+ years.
  • ✓Some gross shoulder movement at start of the trial to enable changes at the elbow/hand, to have the greatest...
  • ✓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.
See the full 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 Is This Study? (2 UK sites)

Royal National Orthopaedic Hospital (Stanmore)

London HA7 4LP, United Kingdom

Recruiting
Site contact (verified)

The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

Oswestry SY10 7AG, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Heba Lakany, PhD

Sponsor contact

CONTACT

+447737353181 heba.lakany@liverpool.ac.uk

Karen Wilding

Sponsor contact

CONTACT

+447717 863747 sponsor@liverpool.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2025-04