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

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.

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 Overview

• Status: Not yet recruiting
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Device: Experimental: Device Intervention

• Study Type: Interventional
• Enrollment (Anticipated): 9
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heba Lakany, PhD; Phone Number: +447737353181; Email: heba.lakany@liverpool.ac.uk
• Study Contact Backup: Name: Karen Wilding; Phone Number: +447717 863747; Email: sponsor@liverpool.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device Intervention; 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.	Device: Experimental: Device Intervention; 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.; Other Names: Robotic Rehabilitation
No Intervention: Control; the matched control group will be the same subjects undergoing traditional rehabilitation only on their non-dominant arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spinal Cord Independence Measure version III (SCIM III)	assesses performance in activities of daily living and mobility for individuals with spinal cord injury	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	Change from baseline (week 1) at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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	Change from baseline (week 1) at 6 weeks and 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)	The QUEST 2.0 evaluates a patient's satisfaction with various assistive technologies.	Change from baseline (week 1) at 6 weeks and 12 weeks

Collaborators and Investigators

• Sponsor: University of Liverpool
• Collaborators: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust; The Queen Elizabeth National Spinal Injuries Unit, Scotland; Stoke Mandeville Spinal Research
• Investigators: Principal Investigator: Heba Lakany, PhD, University of Liverpool; Study Director: Simon J Pickard, Robert Jones and Agnes Hunt Orthopaedic Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): March 1, 2025
• Study Completion (Anticipated): March 1, 2026

Study Registration Dates

• First Submitted: November 2, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: IRAS312522

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes