"Validated Language Transfer of the Spinal Cord Injury-Spasticity Evaluation Tool to German Language"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Score of the Spinal Cord Injury - Spasticity Evaluation Tool german version (SCI-SETde)
研究概览
简要总结
To better depict the full range of spasticity after Spinal Cord Injury (SCI) there is a need to take into account the patients perspective and their experiences during daily life. In 2007 the Spinal Cord Injury-Spasticity Evaluation Tool (SCI-SET) was created and validated. This specific questionnaire addresses the influence of spasticity on the daily life of SCI patients and takes into account negative as well as positive effects of spasticity to fulfill certain tasks. Until now this questionnaire is only available in english, turkish and persian language. Therefore, the investigators translated and culturally adapted this questionnaire and within this study this questionnaire shall be validated in a small cohort of SCI patients. The patients will fill in several different questionnaires at a first meeting and one week later the SCI-SETde questionnaire again to evaluate test-retest properties. Recruiting will happen completely at the Swiss Paraplegic Centre Nottwil, Switzerland.
详细描述
Life expectancy of persons in the acute phase after a spinal cord injury (SCI) dramatically increased in the second half of the last century. The long-term mortality (more than two years post-injury) is still an issue and a strong contributing risk factor are secondary health conditions also including spasticity. Spasticity has been reported to be present in 74% of people in a recent cross-sectional study investigating a cohort including Swiss residents. There are many different forms of spasticity seen in patients as well as varying definitions found in the literature. Furthermore it is recognized that spasticity may have both negative as well as positive impacts on daily life.
Spasticity should not solely be assessed with objective measures and the inclusion of the patient's perspective and personal perception is crucial to completely address and trace out spasticity in each individual. The patient reported impact of spasticity measure (PRISM) as well as the spinal cord injury spasticity evaluation tool (SCI-SET), both established in 2007, are validated and recommended to apply in routine practice. Unfortunately, the SCI-SET is only available in English, Persian and Turkish which hinders the implementation in other language regions.
Therefore the investigators decided to translate and cross-culturally adapt the SCI-SET and create a German version of that questionnaire (SCI-SETde). This finally helps to assess the usefulness of therapeutic interventions and to monitor the course of spasticity in patients. The SCI-SETde will be checked for comprehensibility and tested for cultural aspects in advance to its validation. These are prerequisites that it can later be used in daily routine.
The expected risk and burden for participants is very small because they only have to fill in questionnaires.
The primary objective is to establish the SCI-SETde and to cross-culturally adapt and validate it in a small cohort of patients. The translation and back-translation already happened and the authors of the initial SCI-SET are informed and gave their consent that a German version of this questionnaire may be established.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SCI for at least six month and presented with spasticity symptoms
- •at least 18 years old
- •able to understand the instructions as well as the questionnaires
- •no expected changes in medical treatment for the duration of the study (~1 month)
排除标准
- •inability to provide informed consent
- •co-morbidities (e.g. decubitus ulcers, heterotopic ossification, urinary tract infections or other infections) or any psychological state that influences spasticity
结局指标
主要结局
Score of the Spinal Cord Injury - Spasticity Evaluation Tool german version (SCI-SETde)
时间窗: Two weeks, initial time point and one week later secondary time point
The score is divided into a negative and a positive subscore as well as a given total overall score resulting from the 35 items which can be rated in the range from (-3) "extremely problematic" to +3 "extremely helpful". So the lowest (negative) achievable score is -105 and indicates a high limitation due to spasticity to execute activities of daily living. The highest achievable score is 105 and indicates a high supporting function of spasticity to execute activities of daily living.
Score from the adapted Penn Spasm Frequency Scale (PSFS)
时间窗: One day, initial time point
Frequency score: ranging from 0 "no spasms at all" to 4 "spasms occur more than ten times per hour". The score is descriptive indicating the frequency of spasms. The meaning of the score for the outcome remains open because it depends on several factors. If the spasms are beneficiary for example to transfer from wheelchair to car or bed we have to keep in mind that the patient doesn't need to transfer more than ten times per hour. But it might be helpful if the spasms occur several times per hour. Intensity score: ranging from 1 "weak" to 3 "strong". The score is descriptive indicating the intensity of spasms. The outcome depends on whether the spasms are limiting or helpful for the patient and depending on whether a strong spasm is more helpful than a moderate spasm. It may be that a strong spasm is limiting whereas a moderate spasm is helpful. So there is no general statement possible and the score can only be interpreted by taking all factors into consideration.
Score from Spinal Cord Independence Measure version 3 self-reported (SCIM III - SR)
时间窗: One day, initial time point
The total score of the SCIM III - self reported questionnaire consisting of 19 items. Self-care subscale, Items 1-4 (0-20); Respiration and sphincter management subscale, Items 5-8 (0-40); Mobility subscale, Items 9-17 (0-40) Scores are higher in patients that require less assistance or fewer aids to complete basic activities of daily living and life support activities.
Self-evaluation of limitation in daily life due to spasticity
时间窗: One day, initial time point
The participants are asked to rate the extent of limitation in daily life due to their spasticity on a scale ranging from 0 (no limitation) to 5 (highest imaginable limitation).
Self-evaluation of severity grade of spasticity
时间窗: One day, initial time point
The participants are asked to rate the severity grade of their spasticity on a scale ranging from 0 (no spasticity) to 5 (highest imaginable grade of spasticity).
次要结局
- Asking a question(Two weeks, initial time point and one week later secondary time point)
研究者
Tim Reck
Head of Interventional/Conservative pain medicine
Swiss Paraplegic Research, Nottwil