Validity and Reliability of the 12-item Multiple Sclerosis Walking Scale (12-WS) in Subjects With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 4
- 主要终点
- Validity of the 12-item Multiple Sclerosis Walking Scale (12-WS) in subjects with incomplete SCI.
研究概览
简要总结
Established gait assessments for subjects with spinal cord injury (SCI) (6MWT, 10MWT, TUG, SCIM III and WISCI II) are widely used in the clinical and research setting. So far, no valid measurement exists that assesses the patients' perspective of walking ability in SCI. As there is the 12-item Multiple Sclerosis Walking Scale (12-WS) to assess the patients' perspective on gait ability in patients with multiple sclerosis, it is hypothesized that the 12-WS would also be a valid instrument for subjects with incomplete SCI. The main goal of this study is to collect data from clinical gait assessments in subjects with spinal lesions and to demonstrate that the 12-WS is a valid and reliable patient-reported outcome measurement for individuals with incomplete spinal cord injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years
- •Diagnosis of chronic spinal cord injury (>6 months; cervical or thoracic motor incomplete traumatic or non-traumatic (AIS C, D) above T12
- •Must have impaired walking function as demonstrated by neurological examination.
排除标准
- •Women who are pregnant or breast feeding
- •Current orthopaedic problems of lower limbs
- •History of major cardiac condition (e.g., infarction, insufficiency (NYHA II-IV))
- •History of major pulmonary condition (e.g., chronic obstructive pulmonary disease GOLD II-IV
- •Current major depression or psychosis
- •Participation in another interventional study (except specTra-study) that may have an impact on walking function.
结局指标
主要结局
Validity of the 12-item Multiple Sclerosis Walking Scale (12-WS) in subjects with incomplete SCI.
时间窗: Day 1
The scale is numeric and ranges from 0-100. A lower score means a better outcome.
Re-test reliability of the subjective perceived limitations in ambulation of the 12-item Multiple Sclerosis Walking Scale (12-WS) in subjects with incomplete SCI.
时间窗: Change from day 1 to day 2
The scale is numeric and ranges from 0-100. A lower score means a better outcome.
次要结局
- Walking speed (m/s) - 10-meter walkint test (10MWT)(Day 1)
- Clinical examination (a neurological examination including the ASIA score (categoric outcome grade A-E) - International Standards for Neurological Classification of Spinal Cord Injury(Day 1)
- Walking impairment (numeric value from 0-20) - WISCI II(Day 1)
- Walking distance (m) and number of rests - 6MWT(Day 1)
- Dynamic balance (numeric value from 0-30) - Functional Gait Assessment (FGA)(Day 1)
- Change in impairment level (nominal outcome Yes - No) - Follow up questions in telephone interview(Day 2, maximum 8 weeks after day 1)
- Walking speed including sit-stand transfer (s) - Timed Up and Go-test (TUG)(Day 1)
- Functional independence (numeric value from 0-40) - Spinal Cord Independence Measure III (SCIM III), Items 9-17(Day 1)