Status:
COMPLETED
Refinement and Clinical Evaluation of the H-Man for Arm Rehabilitation After Stroke
Lead Sponsor:
Tan Tock Seng Hospital
Collaborating Sponsors:
National Medical Research Council (NMRC), Singapore
Conditions:
Stroke
Eligibility:
All Genders
21-85 years
Phase:
NA
Brief Summary
Locally, stroke remains the 4th cause of death, causing 8.4% of deaths annually in Singapore, and a leading cause of neurological disability worldwide. Nearly 40% of the stroke survivors will require ...
Detailed Description
As above
Eligibility Criteria
Inclusion
- First ever clinical stroke (ischaemic or haemorrhagic) confirmed on brain imaging
- Duration post stroke: 3 months to 24 months
- Age 21 to 85 years
- Hemiplegic pattern of arm motor impairment with Shoulder abduction MRC motor power \>/= 3/5 and elbow flexion MRC motor power \>/= 3/5
- Affected upper limb Fugl Myer Motor Assessment (FMMA) scale 20-50
- And / or associated motor incoordination or motor ataxia
Exclusion
- Non stroke related causes of arm motor impairment
- Medical conditions incompatible with research participation: uncontrolled medical illnesses (hypertension or diabetes, heart failure, asthma, depression, end stage renal failure, terminal malignancy), life expectancy \<6 months, unhealed fractures or severe arm pain (visual analogue scale VAS \> 5/10, pregnancy
- Inability to tolerate sitting for 90 minutes.
- Local factors which preclude robotic interfacing or may be worsened by intensive arm therapy: spasticity of Modified Ashworth Scale grades 3-4, skin wounds, shoulder pain VAS \>5/10, active fractures or arthritis or fixed flexion contractures of shoulder, elbow, wrist or fingers incompatible with interface with the H-man robot.
- Severe sensory impairment of affected limb
- Severe visual impairment, hemispatial neglect or homonymous hemianopia
- Cognitive impairments or uncontrolled behaviour. (Folstein mini mental state exam MMSE \<26/28)
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2018
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT02188628
Start Date
July 1 2014
End Date
March 31 2018
Last Update
September 12 2019
Active Locations (1)
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1
Tan Tock Seng Rehabilitation Centre
Singapore, Singapore, 569766