Assessment of a Robotic Exoskeleton for Upper Limb Rehabilitation

Spinal Cord Injuries Clinical Trial

— Exo4UL  

Official title:

EXO4UL- Assessment of a Robotic Exoskeleton for Upper Limb Rehabilitation of Spinal Cord Injured Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05615766
• Other study ID #: IRAS312522
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2023
• Est. completion date: March 2026

Study information

• Verified date: November 2022
• Source: University of Liverpool
• Contact: Heba Lakany, PhD
• Phone: +447737353181
• Email: heba.lakany[@]liverpool.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 9
• Est. completion date: March 2026
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University of Liverpool	Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust, Stoke Mandeville Spinal Research, The Queen Elizabeth National Spinal Injuries Unit, Scotland

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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