Trunk Impairment Scale - Adaptation and Validation in French

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorCentre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients over 18 years of age

Patients who have had a stroke

Full understanding of the French language

No cognitive disorders

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Evaluation by the TIS

    Other intervention

    The participant will be evaluated using the TIS on two consecutive days. An evaluation will be conducted by two different evaluators.

Treatment groups

67 Participants
are divided into 1 treatment group
Group A: TISExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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)
2

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)
3

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)
4

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape

Lead sponsor

Groupement des Hôpitaux de l'Institut Catholique de Lille

Collaborator

Universitaire Ziekenhuizen KU Leuven

Collaborator

Rennes University Hospital

Collaborator