Assessment of a Robotic Exoskeleton for Upper Limb Rehabilitation (Exo4UL)

University of Liverpool

Status: Enrolling

Conditions: Spinal Cord Injuries

Treatments: Device: Experimental: Device Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05615766

IRAS312522

Details and patient eligibility

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.

Enrollment: 9 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

---

9 participants in 2 patient groups

Device Intervention

Experimental group

Description:

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.

Treatment:

Device: Experimental: Device Intervention

Control

No Intervention group

Description:

the matched control group will be the same subjects undergoing traditional rehabilitation only on their non-dominant arm.