Centre de Kerpape
Ploemeur, Please Choose..., 56270, France
Location status: Recruiting
Location contact
Longuet Charline, CRA
CONTACT
Plouzennec Jean-Philippe, Physiotherapist
PRINCIPAL_INVESTIGATOR
leplaideur Stéphanie, Doctor
SUB_INVESTIGATOR
NCT Number: NCT07419087
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.
Interested in participating?
Request Info18 year–85 year
All sexes
Interventional
Not applicable
Ploemeur, Please Choose..., 56270, France
Location status: Recruiting
Longuet Charline, CRA
CONTACT
Plouzennec Jean-Philippe, Physiotherapist
PRINCIPAL_INVESTIGATOR
leplaideur Stéphanie, Doctor
SUB_INVESTIGATOR
The research will be conducted in two distinct phases :
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(Phase 1):
Inclusion criteria
(Phase 2):
Exclusion criteria
(Phase 1):
Exclusion criteria
(Phase 2):
The participant will be evaluated using the TIS on two consecutive days. An evaluation will be conducted by two different evaluators.
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.
Time frame: Through Phase 2 completion (up to 21 months)
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:
Time frame: Through Phase 2 completion (up to 21 months)
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:
Time frame: Through Phase 2 completion (up to 21 months)
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)
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)
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
Time frame: Through Phase 2 completion (up to 21 months)
Convergent validity will be evaluated by comparing the TIS with the following scales:
Demeurisse Motor Index : This scale assesses motor control of the upper and lower limbs after a stroke, only on the affected side.
Time frame: Through Phase 2 completion (up to 21 months)
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.
Time frame: Through Phase 2 completion (up to 21 months)
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.
Time frame: Through Phase 2 completion (up to 21 months)
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.
Time frame: Through Phase 2 completion (up to 21 months)
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.
Contact information is provided by the study sponsor or research team.
Jean-Philippe Plouzennec, Kinésithérapeute
CONTACT
Longuet Charline, CRA
CONTACT
Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape
Other
Acronym: KER-TIS fr
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