Stroke (CVA) or TIA, Stroke (CVA) or Transient Ischemic Attack
Conditions
Keywords
traduction, Trunk Impairment Scale, TIS, post-stroke
Brief summary
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.
Detailed description
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.
Interventions
OTHEREvaluation by the TIS
The participant will be evaluated using the TIS on two consecutive days. An evaluation will be conducted by two different evaluators.
Sponsors
Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape
Groupement des Hôpitaux de l'Institut Catholique de Lille
Universitaire Ziekenhuizen KU Leuven
Rennes University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
(Phase 1): * 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
Exclusion criteria
(Phase 1): * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Content validity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| intra-examiner reliability | Through Phase 2 completion (up to 21 months) | The TIS is administered several times by the same examiner at different moments. It is also considered as "the degree to which patients' scores remain the same during repeated measurements under several conditions" over time (test-retest), by the same person at different moments (intra-examiner), and at the same moment by different observers (inter-examiner). Two indices are used: * Cohen's Kappa coefficient, which determines the level of agreement to compare results item by item. Kappa is used for dichotomous item results, and weighted Kappa for ordinal item results. According to Landis and Koch, agreement is considered strong above 0.6. * The intraclass correlation coefficient (ICC) to compare the sub-scores and total scores of the scale. An ICC above 0.8 indicates excellent reliability, between 0.8 and 0.6 good reliability, between 0.6 and 0.4 moderate reliability, and below 0.4 low reliability. |
| inter-examiner reliability | Through Phase 2 completion (up to 21 months) | The TIS is administered at the same moment by different observers. It is also considered as "the degree to which patients' scores remain the same during repeated measurements under several conditions" over time (test-retest), by the same person at different moments (intra-examiner), and at the same moment by different observers (inter-examiner). Two indices are used: * Cohen's Kappa coefficient, which determines the level of agreement to compare results item by item. Kappa is used for dichotomous item results, and weighted Kappa for ordinal item results. According to Landis and Koch, agreement is considered strong above 0.6. * The intraclass correlation coefficient (ICC) to compare the sub-scores and total scores of the scale. An ICC above 0.8 indicates excellent reliability, between 0.8 and 0.6 good reliability, between 0.6 and 0.4 moderate reliability, and below 0.4 low reliability. |
| Internal Consistency | Through Phase 2 completion (up to 21 months) | To assess the internal consistency of behavioral and clinical items. Internal consistency reflects the interrelationship between items and indicates whether each item measures the same underlying construct. Cronbach's alpha coefficient will be calculated. Values \> 0.7 indicate good internal consistency; values close to 1 may indicate redundancy. |
| Standard Error of Measurement | Through Phase 2 completion (up to 21 months) | To calculate the Standard Error of Measurement (SEM) for behavioral and clinical scores. SEM quantifies the variability of repeated measurements and reflects measurement error. It can be influenced by the examiner, the measurement tool, or the patient. SEM is used to compute the Minimum Detectable Change (MDC). |
| Minimum Detectable Change | Through Phase 2 completion (up to 21 months) | To determine the Minimum Detectable Change (MDC) for behavioral and clinical measures. MDC represents the smallest change beyond measurement error that reflects a true change in the patient's condition. It will be calculated using : MDC = SEM \* 1.96 \* √2 |
| Convergent validity | Through Phase 2 completion (up to 21 months) | Convergent validity will be evaluated by comparing the TIS with the following scales: • NIHSS (National Institutes of Health Stroke Scale) : This scale measures the intensity and severity of neurological signs caused by stroke, and monitors their evolution. • Barthel Index : An index assessing functional independence across 10 categories by rating the amount of assistance required by the patient in each domain. Demeurisse Motor Index : This scale assesses motor control of the upper and lower limbs after a stroke, only on the affected side. * 10-Meter Walk Test: * Sit-to-Stand Test |
| Known-groups discrimination | Through Phase 2 completion (up to 21 months) | Known-groups discrimination will be performed by: A subgroup analysis comparing patients who are able to stand independently, those who can walk, those who can walk quickly, those who perform transfers independently, and non-walkers. These categories may be established based on the results of the previously mentioned tests. |
| Concurrent validity | Through Phase 2 completion (up to 21 months) | The concurrent validity of the TIS will be assessed by comparing its scores with established measures of postural control and trunk stability. PASS (36 pts): Evaluates balance in supine, sitting, and standing positions, including transitions. TCT (100 pts): Assesses four trunk movements: rolling toward affected/unaffected side, balancing sitting at edge of bed, and sitting up from lying. EPA (4 pts): Evaluates seated postural balance with or without support, considering induced or self-generated imbalance. Results reported as Pearson or Spearman correlations with TIS scores. |
| Ceiling and Floor Effects | Through Phase 2 completion (up to 21 months) | It demonstrates the difficulty of the tool in measuring the patient's abilities below (floor) or above (ceiling) a certain level. It shows the inadequacy of the tool for the situation of the patient being assessed. To highlight these effects, a large number of patients is required. The distribution of results becomes asymmetrical if one of these effects is observed. |
| Missing data | Through Phase 2 completion (up to 21 months) | The absence of responses to an item will be counted. The relevance of the item may be questioned if it accounts for too many missing responses. |
Countries
France
Contacts
CONTACTJean-Philippe Plouzennec, Kinésithérapeute
CONTACTLonguet Charline, CRA
PRINCIPAL_INVESTIGATORPlouzennec Jean-Philippe, Physiotherapist
Centre de Kerpape
Outcome results
None listed