Exploring a wearable robotic hand device for stroke recovery
An Exploratory Study of a Wearable Robotic Hand Orthosis in the Chronic Stroke Population in Singapore: A Clinic to Home Feasibility Trial
This study is testing a robotic hand device to see if it can help stroke survivors improve their arm and hand movements during therapy and daily activities.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 21 Years to 80 Years |
| Sex | All |
| Sponsor | Tan Tock Seng Hospital Academic / other |
| Locations | 1 site (Singapore, Singapore) |
| Trial ID | NCT06412237 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of the RELab tenoexo, a wearable robotic hand orthosis, to assist chronic stroke survivors in improving their upper limb functionality. The device is designed to support hand movements during therapy exercises and daily activities, aiming to enhance rehabilitation outcomes. The study will assess the feasibility of using this technology in both clinical settings and at home, while also monitoring upper limb usage before, during, and after the training period. The focus is on multi-ethnic stroke populations, addressing a gap in previous research.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 to 80 who have experienced their first stroke at least six months prior and have stable neurological status with specific motor deficits.
Not a fit: Patients with non-stroke related arm impairments or those with unstable medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the functional abilities of stroke survivors, enhancing their quality of life.
How similar studies have performed: Previous studies have shown promise in using assistive technologies for rehabilitation, but this specific approach with the RELab tenoexo is novel for multi-ethnic stroke populations.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Singapore, Singapore
- Tan Tock Seng Hospital — Singapore, Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Tegan Plunkett — Tan Tock Seng Hospital
- Study coordinator: Megan Lau
- Email: megan_se_lau@ttsh.com.sg
- Phone: 68894580
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.