Trunk Impairment Scale - Adaptation and Validation in French (KER-TIS fr)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke (CVA) or TIA; Stroke (CVA) or Transient Ischemic Attack
• Intervention / Treatment: Other: Evaluation by the TIS

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 Type: Interventional
• Enrollment (Estimated): 67
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean-Philippe Plouzennec, Kinésithérapeute; Phone Number: +33 2.97.82.62.93; Email: jean-philippe.plouzennec@vyv3.fr
• Study Contact Backup: Name: Longuet Charline, CRA; Phone Number: +33297826293; Email: charline.longuet@vyv3.fr

Study Locations

• France
  • Please Choose...
    • Ploemeur, Please Choose..., France, 56270
      • Centre de Kerpape
      • Contact: Longuet Charline, CRA; Phone Number: +33 2.97.82.62.93; Email: stephanie.leplaideur@vyv3.fr
      • Principal Investigator: Plouzennec Jean-Philippe, Physiotherapist
      • Sub-Investigator: leplaideur Stéphanie, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TIS	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Through Phase 1 completion (up to 6 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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).	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	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	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.	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.	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.	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.	Through Phase 2 completion (up to 21 months)

Collaborators and Investigators

• Sponsor: Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape
• Collaborators: Universitaire Ziekenhuizen KU Leuven; Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL) - France; CHU Rennes,France
• Investigators: Principal Investigator: Plouzennec Jean-Philippe, Physiotherapist, Centre de Kerpape

Study record dates

Study Major Dates

• Study Start (Estimated): February 24, 2026
• Primary Completion (Estimated): August 24, 2026
• Study Completion (Estimated): July 24, 2028

Study Registration Dates

• First Submitted: October 1, 2025
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: post-stroke; TIS; traduction; Trunk Impairment Scale
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Stroke; Ischemic Attack, Transient
• Other Study ID Numbers: 2024-A01762-45

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No