Refinement and Clinical Evaluation of the H-Man for Arm Rehabilitation After Stroke

Study Overview
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Brief Summary
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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.

Detailed Description
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As above

Official Title
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Refinement and Clinical Evaluation of the H-Man: A Novel, Portable, Inexpensive Planar Robot for Arm Rehabilitation After Stroke

Conditions
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Stroke

Intervention / Treatment
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* Device: H-Man
* Other: Additional Conventional Therapy


Participation Criteria
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Eligibility Criteria
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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 <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)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: H-Man training + conventional therapy vs equal amount of conventional therapy 1:1 allocation
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: H-Man<br>H-Man is a novel, portable, inexpensive end-effector upper limb robot. | Device: H-Man<br>* H-man is a portable end-effector planar upper limb robot.<br>* Other names: No other names.;|
| Active Comparator: Additional Conventional Therapy<br>Repetitive goals based arm therapy | Other: Additional Conventional Therapy<br>* Repetitive goals based arm therapy<br>* Other names: No other names;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Fugl Meyer Assessment of Motor Recovery | As above | 0, 3, 6, 12 and 24 weeks after start of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Action Research Arm Test | As above | 0, 3, 6, 12 and 24 weeks after start of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Motor recovery, robotics, stroke rehabilitation