Trunk Impairment Scale - Adaptation and Validation in French
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Content validity
研究概览
简要总结
The objective of this project is to verify the validity and determine the clinimetric properties after translation and adaptation into French of the Trunk Impairment Scale (TIS), a scale for measuring trunk control and seated balance.
详细描述
The research will be conducted in two distinct phases :
- Phase 1: Translation will follow the methodology of translation/back-translation, structural validation of the produced version, and cognitive interview, as recommended by McKown for Performance Outcome Measures.
- Phase 2: This involves the metrological study, or validity/reliability study. This phase will be conducted at a single center. It follows a cross-sectional design.
The role of the evaluators (between D2 and D3) will be divided so that the TIS assessments and those related to construct validity are carried out by three different therapists in order to maintain the evaluators' "blindness" regarding the patient's functional level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age
- •Patients who have had a stroke
- •Full understanding of the French language
- •No cognitive disorders
- •No prior exposure to the TIS scale
- •Covered by a social security system
- •Having been informed, having agreed to participate in the study, and having signed the free and informed consent form.
- •Inclusion criteria (Phase 2):
- •Patients aged over 18 and under 85 years
- •Having had a stroke, with no time-since-onset limitation
- •Able to sit for 10 seconds without hand support
- •Able to provide informed consent
- •With an NIHSS score between 2 and 26
- •Covered by a social security system
- •Having been informed, having agreed to participate in the study, and having signed the free and informed consent form
排除标准
- •Insufficient command of the French language
- •Inability to understand instructions
- •Persons deprived of liberty (by judicial or administrative decision)
- •Adults under legal protection or unable to express their consent
- •Pregnant or breastfeeding women
- •Exclusion Criteria (Phase 2):
- •Contraindication to the sitting position or to hip adduction (hip prosthesis)
- •History of orthopedic or neurological disorders affecting sitting balance
- •Insufficient command of the French language
- •Inability to understand instructions
- •Person deprived of liberty (by judicial or administrative decision)
- •Adult under legal protection or unable to express consent
- •Pregnant or breastfeeding woman
研究组 & 干预措施
TIS
干预措施: Evaluation by the TIS (Other)
结局指标
主要结局
Content validity
时间窗: Through Phase 1 completion (up to 6 months)
he validity of the content is evaluated at four levels, described in detail in the methodology section of the translation and cross-cultural adaptation phase: By the reading committee (for the translation, reconciliation, and back-translation phases) By a group of professional experts in the field (to approve or not the pre-final versions) By comparing the items of the original TIS with its back-translation, by Prof. Verheyden and his team By a cognitive interview with patients, to assess the proper understanding of each item.
次要结局
- intra-examiner reliability(Through Phase 2 completion (up to 21 months))
- inter-examiner reliability(Through Phase 2 completion (up to 21 months))
- Internal Consistency(Through Phase 2 completion (up to 21 months))
- Standard Error of Measurement(Through Phase 2 completion (up to 21 months))
- Minimum Detectable Change(Through Phase 2 completion (up to 21 months))
- Convergent validity(Through Phase 2 completion (up to 21 months))
- Known-groups discrimination(Through Phase 2 completion (up to 21 months))
- Concurrent validity(Through Phase 2 completion (up to 21 months))
- Ceiling and Floor Effects(Through Phase 2 completion (up to 21 months))
- Missing data(Through Phase 2 completion (up to 21 months))