Refinement and Clinical Evaluation of the H-Man: A Novel, Portable, Inexpensive Planar Robot for Arm Rehabilitation After Stroke
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
- 否
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
H-Man is a novel, portable, inexpensive end-effector upper limb robot.
干预措施: H-Man (Device)
Additional Conventional Therapy
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
Chua Sui Geok, Karen
Senior Consultant
Tan Tock Seng Hospital
