An interventional study of Evaluation by the TIS in Stroke (CVA) or Transient Ischemic Attack and Stroke (CVA) or TIA, sponsored by Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape. Recruiting at 1 site in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape · Not applicable, Interventional, and Other
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.
The research will be conducted in two distinct phases :
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 67 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape is the lead sponsor of 10 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria (Phase 1):
Inclusion criteria (Phase 2):
Exclusion Criteria (Phase 1):
Exclusion Criteria (Phase 2):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Evaluation by the TIS
The participant will be evaluated using the TIS on two consecutive days. An evaluation will be conducted by two different evaluators.
Content validity
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.
Time frame: Through Phase 1 completion (up to 6 months)
intra-examiner reliability
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.
Time frame: Through Phase 2 completion (up to 21 months)
inter-examiner reliability
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.
Time frame: Through Phase 2 completion (up to 21 months)
Internal Consistency
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.
Time frame: Through Phase 2 completion (up to 21 months)
Standard Error of Measurement
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).
Time frame: Through Phase 2 completion (up to 21 months)
Minimum Detectable Change
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
Time frame: Through Phase 2 completion (up to 21 months)
Convergent validity
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
Time frame: Through Phase 2 completion (up to 21 months)
Known-groups discrimination
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.
Time frame: Through Phase 2 completion (up to 21 months)
Concurrent validity
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.
Time frame: Through Phase 2 completion (up to 21 months)
Ceiling and Floor Effects
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.
Time frame: Through Phase 2 completion (up to 21 months)
Missing data
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.
Time frame: Through Phase 2 completion (up to 21 months)
Ran from Mar 2026 to primary completion in Mar 2026, 0 months.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's 0 months is below that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
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Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape