Clinical trial NCT05615766: Assessment of a Robotic Exoskeleton for Upper Limb Rehabilitation
Official title: EXO4UL- Assessment of a Robotic Exoskeleton for Upper Limb Rehabilitation of Spinal Cord Injured Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: University of Liverpool
Sponsor class: OTHER
Collaborators: name: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
name: The Queen Elizabeth National Spinal Injuries Unit, Scotland
name: Stoke Mandeville Spinal Research
First posted: 2022-11-14
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief 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.

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: 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.

Primary outcomes:
measure: Spinal Cord Independence Measure version III (SCIM III)
timeFrame: Change from baseline (week 1) at 6 weeks
measure: Spinal Cord Independence Measure version III (SCIM III)
timeFrame: Change from baseline (week 1) at 12 weeks
Secondary outcomes:
measure: The Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP).
timeFrame: Change from baseline (week 1) at 6 weeks and 12 weeks
measure: The modified Ashworth scale
timeFrame: Change from baseline (week 1) at 6 weeks and 12 weeks
measure: Range of Motion
timeFrame: Change from baseline (week 1) at 6 weeks and 12 weeks
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Change from baseline (week 1) at 6 weeks and 12 weeks
Other outcomes:
measure: The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)
timeFrame: Change from baseline (week 1) at 6 weeks and 12 weeks
Locations:
city: London
country: United Kingdom
facility: Royal National Orthopaedic Hospital (Stanmore)
city: Oswestry
country: United Kingdom
facility: The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Study officials:
affiliation: University of Liverpool
name: Heba Lakany, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Robert Jones and Agnes Hunt Orthopaedic Hospital
name: Simon J Pickard
role: STUDY_DIRECTOR
References: