Guiding Best Practice Clinical Care With In-Silico Rehabilitation and Statistical Parametric Mapping (SPM 1D) for Unilateral Chronic Hemiparetic Stroke and Trans-tibial Amputation: An Exploratory Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Body movement assessed by a motion capture system
研究概览
简要总结
Gait analysis is commonly performed in clinical practice. However, it is complex and requires an understanding of the activation of muscles in lower limbs, trunk, and upper limbs in a specific spatiotemporal pattern and the appropriate joint positions which support and advance the body weight in different phases of gait cycles.
In study, we plan to pilot the application of 3D gait analysis with statistical modelling in 2 common causes of gait deviation: unilateral hemiplegic stroke and unilateral lower limb amputation.
详细描述
This is a pilot study on the use of 3D gait analysis using motion capture in combination with Statistical Parametric Mapping in patients with unilateral hemiplegic stroke and unilateral lower limb amputation. Data collected will then be compared against a normative dataset.
The findings from this study will then be used to build a decision support tool in combination with clinical analysis which could focus clinical recommendations for gait training, physical therapy, exercise and orthotics prescription to reduce unnecessary joint forces in affected and unaffected segments.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Unstable recent cardiorespiratory conditions including uncontrolled hypertension/ hypotension, angina pectoris, myocardial infarction, active congestive cardiac failure, untreated cardiac arrhythmias (e.g. atrial fibrillation), untreated pulmonary embolism or deep vein thrombosis, presence of cardiac pacemaker.
- •Functional status: severe aphasia or neglect (inability to obey 1 steps command), communication disorder precluding understanding of instructions, cognitive impairment, dementia, untreated depression or psychiatric disorder.
- •End stage conditions such as medical instability or orthostatic insufficiency, organ, renal, liver, heart failure and life expectancy <6 months or on haemodialysis.
- •Pregnancy.
- •Local limb conditions which could be exacerbated by research interventions such as open wounds, ulcers, stump pain or stump wounds/ulcers, neuromas in amputees, active arthritis or joint or limb pain.
- •Skin conditions which could be worsened by application of adhesive skin markers such as uncontrolled eczema, psoriasis, fungal or bacterial infections etc.
结局指标
主要结局
Body movement assessed by a motion capture system
时间窗: Assessed within 1 year after patient recruitment
Direction and magnitude of each body movement will be combined to provide graphical data on a motion capture system
次要结局
- Stroke Impact Scale(Assessed within 1 year after patient recruitment)
- Amputee Mobility Predictor with prosthesis(Assessed within 1 year after patient recruitment)
- Fugl Meyer Assessment(Assessed within 1 year after patient recruitment)