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Assessment of a Robotic Exoskeleton for Upper Limb Rehabilitation

NCT05615766 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-09-04

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

    collaborator OTHER_GOV

  • The Queen Elizabeth National Spinal Injuries Unit, Scotland

    collaborator UNKNOWN

  • Stoke Mandeville Spinal Research

    collaborator UNKNOWN

  • University of Liverpool

    lead OTHER

Principal Investigators

  • Heba Lakany, PhD · University of Liverpool

  • Simon J Pickard · Robert Jones and Agnes Hunt Orthopaedic Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2025-09-30
Completion
2026-03-31
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05615766 on ClinicalTrials.gov