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| Name | Class |
|---|---|
| Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust | OTHER_GOV |
| The Queen Elizabeth National Spinal Injuries Unit, Scotland | UNKNOWN |
| Stoke Mandeville Spinal Research | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | No Intervention | the matched control group will be the same subjects undergoing traditional rehabilitation only on their non-dominant arm. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heba Lakany, PhD | Contact | +447737353181 | heba.lakany@liverpool.ac.uk | |
| Karen Wilding | Contact | +447717 863747 | sponsor@liverpool.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Heba Lakany, PhD | University of Liverpool | Principal Investigator |
| Simon J Pickard | Robert Jones and Agnes Hunt Orthopaedic Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal National Orthopaedic Hospital (Stanmore) | Recruiting | London | HA7 4LP | United Kingdom |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| 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 |
| The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust | Recruiting | Oswestry | SY10 7AG | United Kingdom |
|
| D014947 | Wounds and Injuries |