Assessment of a Robotic Exoskeleton for Upper Limb Rehabilitation

ConditionSpinal Cord Injuries

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Liverpool

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

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. 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.

Treatment groups

9 Participants

are divided into 2 treatment groups

Group A: Device InterventionExperimental treatment 1 intervention

Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

Spinal Cord Independence Measure version III (SCIM III)

assesses performance in activities of daily living and mobility for individuals with spinal cord injury

Time frame

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

Time frame

Change from baseline (week 1) at 12 weeks

Secondary outcomes

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.

Time frame