Stroke (CVA) or Transient Ischemic AttackKER-TIS frNCT07419087
Trunk Impairment Scale - Adaptation and Validation in French
A study testing Evaluation by the TIS in people with Stroke (CVA) or Transient Ischemic Attack and Stroke (CVA) or TIA, run by Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke (CVA) or Transient Ischemic Attack, Stroke (CVA) or TIA
- What is being tested?
- Evaluation by the TIS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteFrance
- Study dates
- 19 Mar 2026to 19 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Having been informed, having agreed to participate in the study, and having signed the free and informed consent form.
- 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
Who cannot join
- 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
- Contraindication to the sitting position or to hip adduction (hip prosthesis)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre de Kerpape
Ploemeur, Please Choose..., 56270
Longuet Charline, CRA, +33 2.97.82.62.93, stephanie.leplaideur@vyv3.fr
Plouzennec Jean-Philippe, Physiotherapist
About this study
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.
Read the 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.
- Being tested
- Evaluation by the TIS
- Keywords
- traduction, Trunk Impairment Scale, TIS, post-stroke
- Medical subject headings
- Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation by the TISOther
The participant will be evaluated using the TIS on two consecutive days. An evaluation will be conducted by two different evaluators.
| Study group | Role | What they receive |
|---|---|---|
| TIS | Experimental | Not described Receives: Other: Evaluation by the TIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through Phase 1 completion (up to 6 months)
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through Phase 2 completion (up to 21 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start19 Mar 2026
- Primary completion25 Mar 2026
- Study completion19 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke (CVA) or Transient Ischemic AttackStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape
- Sponsor type
- University, hospital or other
- Collaborators
- Groupement des Hôpitaux de l'Institut Catholique de Lille, Universitaire Ziekenhuizen KU Leuven, Rennes University Hospital
- Responsible party
- Sponsor
- Investigators
- Plouzennec Jean-Philippe, Physiotherapist, Principal investigator, Centre de Kerpape
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419087
- Sponsor's protocol ID
- 2024-A01762-45
- Acronym
- KER-TIS fr
- Status last verified
- Jun 2026
- First submitted
- 1 Oct 2025
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trunk Impairment Scale - Adaptation and Validation in French
- ClinicalTrials.gov ID
- NCT07419087
- Acronym / sponsor ID
- KER-TIS fr / 2024-A01762-45
- Keywords
- traduction, Trunk Impairment Scale, TIS, post-stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de KerpapeUniversity, hospital or other
- Collaborators
- Groupement des Hôpitaux de l'Institut Catholique de Lille, Universitaire Ziekenhuizen KU Leuven, Rennes University Hospital
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- 25 Mar 2026 (actual)
- Study completion
- 19 Jul 2028 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TIS | Experimental | Other: Evaluation by the TIS |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation by the TISThe participant will be evaluated using the TIS on two consecutive days. An evaluation will be conducted by two different evaluators. | Other | TIS |
Primary outcome
Content validity
Time frame: 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.
10 secondary outcomes
intra-examiner reliability
Time frame: Through Phase 2 completion (up to 21 months)
inter-examiner reliability
Time frame: Through Phase 2 completion (up to 21 months)
Internal Consistency
Time frame: Through Phase 2 completion (up to 21 months)
Standard Error of Measurement
Time frame: Through Phase 2 completion (up to 21 months)
Minimum Detectable Change
Time frame: Through Phase 2 completion (up to 21 months)
Convergent validity
Time frame: Through Phase 2 completion (up to 21 months)
Known-groups discrimination
Time frame: Through Phase 2 completion (up to 21 months)
Concurrent validity
Time frame: Through Phase 2 completion (up to 21 months)
Ceiling and Floor Effects
Time frame: Through Phase 2 completion (up to 21 months)
Missing data
Time frame: Through Phase 2 completion (up to 21 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Plouzennec Jean-Philippe, Physiotherapist principal investigator
Centre de Kerpape
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation by the TIS in people with Stroke (CVA) or Transient Ischemic Attack and Stroke (CVA) or TIA, run by Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Philippe Plouzennec, Kinésithérapeute (+33 2.97.82.62.93, jean-philippe.plouzennec@vyv3.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Content validity (time frame: Through Phase 1 completion (up to 6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.