RECRUITINGINTERVENTIONAL
An Exploratory Study of a Wearable Robotic Hand Orthosis
An Exploratory Study of a Wearable Robotic Hand Orthosis in the Chronic Stroke Population in Singapore: A Clinic to Home Feasibility Trial
About This Trial
Upper limb deficits usually remain in 75% of the stroke survivors despite completing full rehabilitation. This is due to lack of effectiveness of rehabilitation and the degree of support and resources available. In this study, the investigators plan to study the use of assistive technologies in chronic stroke survivors.
Who May Be Eligible (Plain English)
Who May Qualify:
- Patient with first ever clinical stroke (ischaemic or haemorrhagic) with hemiplegic motor deficit(s) due to stroke as diagnosed by CT or MRI.
- Post stroke of at least 6 months with stable neurological status.
- Age 21 to 80 years of age.
- Hemiplegic pattern and shoulder abduction MRC motor power \> 2/5 and elbow extension \>2/5
- Has a stable home abode and a carer/NOK to assist with donning of device and supervise home based exercise
- MOCA \> or equal to 22/30
- Able to give and sign willing to sign a consent form at research site.
- Able to speak English
Who Should NOT Join This Trial:
- Non-stroke related causes of arm motor impairment.
- Has unstable or terminal medical conditions which may affect participation (e.g.: unresolved sepsis, postural hypotension, end stage renal failure, cancer, retroviral disease, on immunosuppressive therapy) or anticipated life expectancy of \<1 year due to malignancy or neurodegenerative disorder.
- Local factors which may be worsened by intensive arm therapy: spasticity of Modified Ashworth Scale grades 3-4, skin wounds, shoulder pain Pain Scale \>5/10, active/non-united fractures or arthritis or fixed joint/tissue flexion contractures of shoulder, elbow, wrist or fingers incompatible with tenoexo interface.
- Patient with severe cognitive, perceptual (include hemi-neglect), and/or emotional-behavioural issues that preclude participation.
- Experiencing moderate to severe levels of pain (Numerical Vertical Pain Scale \> 5).
- Is pregnant or breast feeding. Neither the tenoexo nor the IMUs have been tested to evaluate the usage with pregnant and/or breast feeding mothers. Further, due to the length of the study, pregnancy may make it difficult to follow the study schedule.
- Have a pacemaker. Magnets are used throughout the system.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Patient with first ever clinical stroke (ischaemic or haemorrhagic) with hemiplegic motor deficit(s) due to stroke as diagnosed by CT or MRI.
* Post stroke of at least 6 months with stable neurological status.
* Age 21 to 80 years of age.
* Hemiplegic pattern and shoulder abduction MRC motor power \> 2/5 and elbow extension \>2/5
* Has a stable home abode and a carer/NOK to assist with donning of device and supervise home based exercise
* MOCA \> or equal to 22/30
* Able to give and sign informed consent at research site.
* Able to speak English
Exclusion Criteria:
* Non-stroke related causes of arm motor impairment.
* Has unstable or terminal medical conditions which may affect participation (e.g.: unresolved sepsis, postural hypotension, end stage renal failure, cancer, retroviral disease, on immunosuppressive therapy) or anticipated life expectancy of \<1 year due to malignancy or neurodegenerative disorder.
* Local factors which may be worsened by intensive arm therapy: spasticity of Modified Ashworth Scale grades 3-4, skin wounds, shoulder pain Pain Scale \>5/10, active/non-united fractures or arthritis or fixed joint/tissue flexion contractures of shoulder, elbow, wrist or fingers incompatible with tenoexo interface.
* Patient with severe cognitive, perceptual (include hemi-neglect), and/or emotional-behavioural issues that preclude participation.
* Experiencing moderate to severe levels of pain (Numerical Vertical Pain Scale \> 5).
* Is pregnant or breast feeding. Neither the tenoexo nor the IMUs have been tested to evaluate the usage with pregnant and/or breast feeding mothers. Further, due to the length of the study, pregnancy may make it difficult to follow the study schedule.
* Have a pacemaker. Magnets are used throughout the system.
Treatments Being Tested
DEVICE
RELab tenoexo
The RELab tenoexo is a fully wearable and portable RHO developed at the Rehabilitation Engineering Laboratory (RELab) at ETH Zurich.
Locations (1)
Tan Tock Seng Hospital
Singapore, Singapore, Singapore