Muscle Ultrasound as a Predictor of Functional Status in Spinal Cord Injury Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Spinal Cord Independence Measure (SCIM) III
研究概览
简要总结
Establish if change from the baseline in ultrasound muscle parameters over 2 months of rehabilitation correlates with functional status of SCI patients at the end of rehabilitation
详细描述
Rehabilitation is the key to ambulatory recovery in patients with spinal cord injury, although only 25% of patients regain this ability despite current rehabilitation protocols. There is emerging evidence that intensive and prolonged rehabilitation, though costly and manpower intensive, may result in ambulatory recovery in patients previously thought to be non-ambulant. However, there are no suitable clinical biomarkers which can identify these group of patients who will benefit from this intervention.
Hence the aim is to establish if change from the baseline in ultrasound muscle parameters over rehabilitation correlates with functional status of SCI patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •First ever acute SCI
- •Age 21-65 years
- •Presence of weakness in the lower limbs (defined as either ASIA A, B, C or D)
- •Independent in ambulation prior to onset of SCI
- •Able to understand study procedures and sign informed consent
- •Clinical suitability for rehabilitation
排除标准
- •Presence of premorbid lower musculoskeletal conditions eg contractures, fractures, previous operations, that prevents proper ultrasound assessment of the affected limb
- •Cardiorespiratory conditions eg congestive cardiac failure (EF<40%), chronic arrhythmias, COPD stage 3-4
- •End stage illness, end stage renal failure, life expectancy <6 months
- •Other active neurological conditions
- •Botulinum toxin injection over the past 3 months
结局指标
主要结局
Spinal Cord Independence Measure (SCIM) III
时间窗: Performed at 1 year
It is used by health care practitioners to assess and grade the functional status of a person based on the level of assistance he or she requires, in patients with spinal cord injury. Only the patient's indoor mobility subscore will be assessed from abilities, graded from 0-8.
Walking Index for Spinal Cord Injury II (WISCI II)
时间窗: Performed on 1 year
A walking scale used by health care practitioners to grade the walking ability of SCI patients.
Functional Independence Score
时间窗: Performed at 1 year
An 18-item of physical, psychological and social function (graded from 1-7)
ASIA score
时间窗: Performed at 1 year
This is an assessor administered test that systematically examines the dermatomes and myotomes in spinal cord patients through testing the strength and sensation
次要结局
- Range of motion of elbow, hip and knee(Performed at 1 year)
- Spasticity(Performed at 1 year)