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Recruiting NCT07419087

Trunk Impairment Scale - Adaptation and Validation in French

No phase Interventional Stroke (CVA) or Transient Ischemic Attack Stroke (CVA) or TIA

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Evaluation by the TIS.
Who it may be relevant to
Registry conditions: Stroke (CVA) or Transient Ischemic Attack, Stroke (CVA) or TIA. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • 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.

Primary outcome measures

  • Content validity [Time frame: Through Phase 1 completion (up to 6 months)]
Secondary outcome measures (10)
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • Centre de Kerpape — Ploemeur

Identifiers

NCT: NCT07419087 · 2024-A01762-45

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗