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临床试验/NCT02188628
NCT02188628已完成不适用

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

Tan Tock Seng Hospital2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2014年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
44
试验地点
2
主要终点
Change from Baseline in Fugl Meyer Assessment of Motor Recovery

研究概览

简要总结

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.

详细描述

As above

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

Blinded therapist assessor to determine clinical outcomes at pre and post treatment and follow up.

入排标准

年龄范围
21 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

研究组 & 干预措施

H-Man

Experimental

H-Man is a novel, portable, inexpensive end-effector upper limb robot.

干预措施: H-Man (Device)

Additional Conventional Therapy

Active Comparator

Repetitive goals based arm therapy

干预措施: Additional Conventional Therapy (Other)

结局指标

主要结局

Change from Baseline in Fugl Meyer Assessment of Motor Recovery

时间窗: 0, 3, 6, 12 and 24 weeks after start of intervention

As above

次要结局

  • Change from Baseline in Action Research Arm Test(0, 3, 6, 12 and 24 weeks after start of intervention)

研究者

发起方
Tan Tock Seng Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chua Sui Geok, Karen

Senior Consultant

Tan Tock Seng Hospital

研究点 (2)

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