NCT07419087

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
23mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress16%
Mar 2026Jul 2028

First Submitted

Initial submission to the registry

October 1, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
29 days until next milestone

Study Start

First participant enrolled

March 19, 2026

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2026

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2028

Expected
Last Updated

June 24, 2026

Status Verified

June 1, 2026

Enrollment Period

6 days

First QC Date

October 1, 2025

Last Update Submit

June 22, 2026

Conditions

Stroke (CVA) or Transient Ischemic AttackStroke (CVA) or TIA

Keywords

traductionTrunk Impairment ScaleTISpost-stroke

Outcome Measures

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.

    Through Phase 1 completion (up to 6 months)

Secondary Outcomes (10)

  • intra-examiner reliability

    Through Phase 2 completion (up to 21 months)

  • inter-examiner reliability

    Through Phase 2 completion (up to 21 months)

  • Internal Consistency

    Through Phase 2 completion (up to 21 months)

  • Standard Error of Measurement

    Through Phase 2 completion (up to 21 months)

  • Minimum Detectable Change

    Through Phase 2 completion (up to 21 months)

  • +5 more secondary outcomes

Study Arms (1)

TIS

EXPERIMENTAL
Other: Evaluation by the TIS

Interventions

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.

TIS

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Kerpape

Ploemeur, Please Choose..., 56270, France

RECRUITING

MeSH Terms

Conditions

StrokeIschemic Attack, Transient

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain Ischemia

Study Officials

  • Plouzennec Jean-Philippe, Physiotherapist

    Centre de Kerpape

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Philippe Plouzennec, Kinésithérapeute

CONTACT

+33 2.97.82.62.93jean-philippe.plouzennec@vyv3.fr

Longuet Charline, CRA

CONTACT

+33297826293charline.longuet@vyv3.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2025

First Posted

February 18, 2026

Study Start

March 19, 2026

Primary Completion

March 25, 2026

Study Completion (Estimated)

July 19, 2028

Last Updated

June 24, 2026

Record last verified: 2026-06

Locations

FR(1)