Actively Recruiting
EXO4UL- Assessment of a Robotic Exoskeleton for Upper Limb Rehabilitation of Spinal Cord Injured Patients
Led by University of Liverpool · Updated on 2025-09-04
9
Participants Needed
2
Research Sites
21 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
This research aims to evaluate the effectiveness of a commercial robotic orthosis, also known as a robotic exoskeleton, for upper limb rehabilitation in patients with spinal cord injuries. The study focuses on tetraplegic inpatients with specific spinal injury levels and aims to assess improvements in arm function and independence. The study is conducted in two neuro-rehabilitation centers within the NHS in the UK, involving nine participants in total. Participants will undergo a twelve-week rehabilitation program using the Myomo robotic orthosis on their dominant arm, combined with their usual care and traditional rehabilitation. They will attend three to four sessions per week, each lasting about 45 minutes. The non-dominant arm will receive only the traditional rehabilitation, serving as a control for comparison. The study evaluates the use of this device alongside standard rehabilitation practices. Throughout the study, participants will be assessed at the start, midpoint (6 weeks), and end (12 weeks) of the program. Measurements will include arm function, range of motion, spasticity level, and independence using clinical tools like the Spinal Cord Independence Measure version III (SCIM III) and others. Researchers will also gather feedback on patient and therapist satisfaction with the robotic device. The total participation duration is approximately 12 weeks, with ongoing monitoring of clinical changes.
CONDITIONS
Brief Title
Assessment of a Robotic Exoskeleton for Upper Limb Rehabilitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Spinal cord injury levels C5 or C6 with elbow and hand impairment
- Some gross shoulder movement to enable functional change at elbow and hand
- Preservation of hand sensation
- Some sitting balance to allow functional upper limb activity
- Evidence of active muscle activity in fingers and elbow (EMG grade 1-2)
- Minimal or no functional use of upper limb in the community at trial start
- Spasticity level between 1 and 3 on the Modified Ashworth Scale
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
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants undergo rehabilitation using the MARK robotic exoskeleton on their dominant arm in addition to traditional rehabilitation and standard care.
Up to 4 sessions per week, total of 48 sessions
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
Research Team
H
Heba Lakany, PhD
K
Karen Wilding
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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