refinement and clinical evaluation of the h-man for arm rehabilitation after stroke

Conditions: Stroke

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 specialized rehabilitation. in recent years, robot-aided therapy has been proposed as a means of complementing traditional therapy to alleviate the burden on therapists and on the healthcare system. for shoulder/elbow rehabilitation, dozens of robots have been proposed in the literature but only half a dozen have been commercialized and typically none are seen in local clinics, due to exceedingly high costs. a novel, compact, inexpensive robotic interface, named 'h-man', was recently designed and developed at ntu for experiments in motor control neuroscience. the h-man can generate computer-controlled force fields to assist or resist a subject's motion and is potentially an optimal trade-off between clinical efficacy and robotic complexity. a first prototype of the h-man is available at ntu.the primary aim of this proposed project is to assess to what extent the investigators h-man is suitable for rehabilitation purposes using a feasibility pilot clinical trial design involving stroke survivors. the investigators believe that h-man can be used for neuro-rehabilitation of stroke patients with hemiparetic weakness, motor incoordination and motor ataxia of the upper limbs.in close cooperation between clinicians at the ttsh and ntu engineers, a portable version of the h-man will be developed which will be tested in a 12 subject pilot study, refined and then used in a 44 subject randomized controlled trial (rct) study. at the same time, the feasibility of h-man integration for a pared down home use model will be assessed in 4 subjects. the investigators primary hypothesis is that sub-acute/chronic patients will exhibit clinically significant decreases of impairment when training with the h-man combined with standard arm therapy on robot-measured scales and standardized clinical scales, at the level of elbow/shoulder after 18 sessions of training on the h-man.

as above

Eligibility criteria:
inclusion criteria: * 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 criteria: * 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 \ 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)

Keywords: motor recovery, robotics, stroke rehabilitation