An Exploratory Study of a Wearable Robotic Hand Orthosis

ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-80
SponsorTan Tock Seng Hospital

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • RELab tenoexo

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators