An Exploratory Study of a Wearable Robotic Hand Orthosis

Recruiting now · Not applicable

Conditions studied: Stroke

In brief

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.

Key facts

Study ID

NCT06412237

Run by

Tan Tock Seng Hospital

People needed

20

Starts

2024-06-01

Expected to finish

2026-01-01

Last updated by the study team

2025-04-15

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Tan Tock Seng Hospital — Singapore, Singapore, Singapore (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.