Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-01-02 @ 1:01 AM
Study NCT ID:
NCT05615766
Status:
RECRUITING
Last Update Posted:
2025-09-04
First Post:
2022-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of a Robotic Exoskeleton for Upper Limb Rehabilitation
Sponsor:
University of Liverpool
Organization:
Study Overview
Official Title:
EXO4UL- Assessment of a Robotic Exoskeleton for Upper Limb Rehabilitation of Spinal Cord Injured Patients
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Exo4UL
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: