An Exploratory Study of a Wearable Robotic Hand Orthosis

Launched by TAN TOCK SENG HOSPITAL · May 8, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new device called a wearable robotic hand orthosis, which is designed to help people who have had a stroke and still have difficulties using their arms. Many stroke survivors, about 75%, continue to struggle with movement in their upper limbs even after rehabilitation. This study aims to see how assistive technologies like the robotic hand can improve their ability to use their arms effectively in daily life.

To be eligible for this study, participants should be between 21 and 80 years old and must have had their first stroke at least six months ago, with some movement ability in their arm. They should also be able to communicate in English and have a stable home environment with someone to assist them. If you or someone you know meets these criteria and is interested in participating, you can expect to work with the device and receive guidance on exercises to help improve arm function. It's important to note that certain medical conditions, like severe pain or cognitive issues, may prevent eligibility, so those will be assessed before joining the study.

Gender

ALL

Eligibility criteria

• 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.