Spinal Cord InjuriesExo4ULNCT05615766
Assessment of a Robotic Exoskeleton for Upper Limb Rehabilitation
A study testing Experimental: Device Intervention in people with Spinal Cord Injuries, run by University of Liverpool at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Experimental: Device Intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Sep 2022to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
Royal National Orthopaedic Hospital (Stanmore)
London, HA7 4LP
Emma Linley, 020 3947 0100, LSCIResearch@nhs.net
- Recruiting
The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Oswestry, SY10 7AG
Simon Pickard, 01691 404000, simon.pickard1@nhs.net
About this study
Official title: EXO4UL- Assessment of a Robotic Exoskeleton for Upper Limb Rehabilitation of Spinal Cord Injured Patients
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.
Read more
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
- Spinal Cord Injuries
- Being tested
- Experimental: Device Intervention
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Device InterventionDevice
Also called Robotic Rehabilitation
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.
| Study group | Role | What they receive |
|---|---|---|
| Device Intervention | Experimental | The intervention group who will be undergoing rehabilitation using the robotic exoskeleton in addition to the assigned traditional rehabilitation programme on their dominant arm only. Receives: Device: Experimental: Device Intervention |
| Control | No intervention | the matched control group will be the same subjects undergoing traditional rehabilitation only on their non-dominant arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal Cord Independence Measure version III (SCIM III)
assesses performance in activities of daily living and mobility for individuals with spinal cord injury
Measured: Change from baseline (week 1) at 6 weeks
Spinal Cord Independence Measure version III (SCIM III)
assesses performance in activities of daily living and mobility for individuals with spinal cord injury
Measured: Change from baseline (week 1) at 12 weeks
Secondary outcomes (4)
The Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP).
The GRASSP is a clinical impairment measure for the upper limb for use after tetraplegia. The measure includes three domains which are important in describing hand function.
Measured: Change from baseline (week 1) at 6 weeks and 12 weeks
The modified Ashworth scale
Ashworth scale is the most universally accepted clinical spasticity assessment tool used to measure the increase of muscle tone.
Measured: Change from baseline (week 1) at 6 weeks and 12 weeks
Range of Motion
to assess the capability of a joint to go through its complete spectrum of movements
Measured: Change from baseline (week 1) at 6 weeks and 12 weeks
Canadian Occupational Performance Measure (COPM)
COPM assesses the patient's perceived occupational performance in the areas of selfcare, productivity, and leisure
Measured: Change from baseline (week 1) at 6 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start1 Sep 2022
- Primary completion30 Sep 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust, The Queen Elizabeth National Spinal Injuries Unit, Scotland, Stoke Mandeville Spinal Research
- Responsible party
- Sponsor
- Investigators
- Heba Lakany, PhD, Principal investigator, University of LiverpoolSimon J Pickard, Study director, Robert Jones and Agnes Hunt Orthopaedic Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615766
- Sponsor's protocol ID
- IRAS312522
- Acronym
- Exo4UL
- Status last verified
- Apr 2025
- First submitted
- 2 Nov 2022
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXO4UL- Assessment of a Robotic Exoskeleton for Upper Limb Rehabilitation of Spinal Cord Injured Patients
- ClinicalTrials.gov ID
- NCT05615766
- Acronym / sponsor ID
- Exo4UL / IRAS312522
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Collaborators
- Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust, The Queen Elizabeth National Spinal Injuries Unit, Scotland, Stoke Mandeville Spinal Research
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device Intervention | Experimental | Device: Experimental: Device InterventionThe intervention group who will be undergoing rehabilitation using the robotic exoskeleton in addition to the assigned traditional rehabilitation programme on their dominant arm only. |
| Control | No intervention | –the matched control group will be the same subjects undergoing traditional rehabilitation only on their non-dominant arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Device InterventionAlso: Robotic RehabilitationThe 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. | Device | Device Intervention |
Primary outcome
Spinal Cord Independence Measure version III (SCIM III)
Time frame: Change from baseline (week 1) at 6 weeks
assesses performance in activities of daily living and mobility for individuals with spinal cord injury
Spinal Cord Independence Measure version III (SCIM III)
Time frame: Change from baseline (week 1) at 12 weeks
assesses performance in activities of daily living and mobility for individuals with spinal cord injury
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Heba Lakany, PhD principal investigator
University of Liverpool
Simon J Pickard study director
Robert Jones and Agnes Hunt Orthopaedic Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Device Intervention in people with Spinal Cord Injuries, run by University of Liverpool at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heba Lakany, PhD (+447737353181, heba.lakany@liverpool.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spinal Cord Independence Measure version III (SCIM III) (time frame: Change from baseline (week 1) at 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.