Assessment of a Robotic Exoskeleton for Upper Limb Rehabilitation

NCT05615766 | Recruiting FDA Device

• 1 other identifier: IRAS312522
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• The Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP).

  Change from baseline (week 1) at 6 weeks and 12 weeks

• The modified Ashworth scale

  Change from baseline (week 1) at 6 weeks and 12 weeks

• Range of Motion

  Change from baseline (week 1) at 6 weeks and 12 weeks

• Canadian Occupational Performance Measure (COPM)

  Change from baseline (week 1) at 6 weeks and 12 weeks

Other Outcomes (1)

• The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)

  Change from baseline (week 1) at 6 weeks and 12 weeks

Study Arms (2)

Device Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

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.

Also known as: Robotic Rehabilitation

Device Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Liverpool: lead
• Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust: collaborator
• The Queen Elizabeth National Spinal Injuries Unit, Scotland: collaborator
• Stoke Mandeville Spinal Research: collaborator

Study Sites (2)

Royal National Orthopaedic Hospital (Stanmore)

London, HA7 4LP, United Kingdom

RECRUITING

The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

Oswestry, SY10 7AG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Heba Lakany, PhD

  University of Liverpool

  PRINCIPAL INVESTIGATOR

• Simon J Pickard

  Robert Jones and Agnes Hunt Orthopaedic Hospital

  STUDY DIRECTOR

Central Study Contacts

Heba Lakany, PhD

CONTACT

+447737353181; heba.lakany@liverpool.ac.uk

Karen Wilding

CONTACT

+447717 863747; sponsor@liverpool.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 14, 2022
• Study Start: September 1, 2022
• Primary Completion: September 30, 2025
• Study Completion: March 1, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-04

Locations

GB (2)