Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05615766

Assessment of a Robotic Exoskeleton for Upper Limb Rehabilitation

Led by University of Liverpool · Updated on 2025-09-04

9

Participants Needed

2

Research Sites

182 weeks

Total Duration

On this page

Sponsors

U

University of Liverpool

Lead Sponsor

R

Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Assessment of a Robotic Exoskeleton for Upper Limb Rehabilitation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Spinal cord injury at levels C5, C6 (Asia C/D), C7, or C8
  • Some gross shoulder movement at the start of the trial
  • Preservation of hand sensation as a basis for motor restoration
  • Some sitting balance to enable functional upper limb activity
  • EMG evidence of active finger and elbow movements grade 1-2
  • Minimal or no functional use of upper limb in the community at trial start
  • Spasticity level between MAS 1-3/5
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Royal National Orthopaedic Hospital (Stanmore)

London, United Kingdom, HA7 4LP

Actively Recruiting

2

The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

Oswestry, United Kingdom, SY10 7AG

Actively Recruiting

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Research Team

H

Heba Lakany, PhD

CONTACT

K

Karen Wilding

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

2

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