Clinical trial NCT04061616: Transcultural Validation of the Physical Activity Scale for Individuals With Physical Disabilities (PASIPD) in French: The PASIPD-Fr
Official title: Transcultural Validation of the Physical Activity Scale for Individuals With Physical Disabilities (PASIPD) in French: The PASIPD-Fr
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Disability
Neurological Diseases or Conditions
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2019-08-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The Physical Activity Scale for Individuals With Physical Disabilities (PASIPD) is a scale that has been developped and validated in English to quantify the level of physical activity for people with physical disabilities. The investigators aimed to translate and validate a French transcultural version of the PASIPD (PASIPD-Fr) through a rigourous process following international recommendations for cross-cultural translation and adaptation of questionnaires.

Detailed description: For the translation, permission to proceed was obtained, and translation was conducted in consultation with the developers. The investigators proceed to a first translation of the initial scale from English to French with two French native bilingual physicians that resulted in a unique french translation. An English native bilingual physicians proceeded to a back translation from French to English. This version have been sent to the developers who agreed that this back translated version was faithful to the original scale.

For the validation, the investigators used the international recommendations for cross-cultural translation and adaptation of questionnaires. Population was individuals with neurological disease (stroke, multiple sclerosis, Parkinson disease and neuromuscular disorders) with significant in physical disability. Patients were invited in an ambulatory setting. Data collected for every participant included demographic and general variables (age, sex, level, cause and time since neurological disease, walking capacities and aid), scores of a physical performance tests (10 Meter Walking Test, 10 MWT) and the 4 self-administered questionnaires: the Dijon Physical Activity Scale (PAS) the Activities-specific Balance Confidence (ABC) Scale, the Medical Outcome Study Short Form 12 " (MOS SF-12) and the Hospital Anxiety and Depression (HAD) scale.

Face validity was assessed using verbal feedbacks from physician and patients, and the mean time to fill-out the scale.

Criterion validity was assessed with correlation and discrimination analysis between the scores for the PASIPD-Fr and the Dijon PAS.

Construct validity was assessed using the correlation with scores of instruments that measure various aspects related to and physical activity (convergent validity) such as the self-reported questionaires ABC, SF-12 and HAD scales and also the 10 MWT.

For consistency and reliability, the investigators calculated the Cronbach α coefficient and calculated the ICC between 2 completions at a 2-week interval.

Sample calculation was based on an expected ICC \> 0.9, which required 50 participants to reject the hypothesis that the actual ICC is \< 0.6, which corresponds to the lower limit for a "good" reproducibility.

Eligibility criteria: Inclusion Criteria:

* Patient who received research information
* Patient affiliated to a social security system
* Patient over 18 years of age
* Patients with physical disabilities (Act No. 2005-102 on equal rights and opportunities)
* Individuals with the following disease: stroke survivors, multiple sclerosis, neuromuscular disease and idiopathic Parkinson's disease

Exclusion Criteria:

* Patient not affiliated to a social security system.
* Patients under guardianship or curators or protection of justice.
* Lack of informed information about the study
* Alteration of higher functions or sensory disturbance making it impossible to understand and adhere to the research protocol
* A severe medical condition that significantly alters functional abilities (severe heart failure, respiratory failure, unstable metabolic disorders such as active renal failure) and involves a life-threatening condition in the short to medium term (progressive neoplastic pathology, unstable systemic disease).

Primary outcomes:
measure: Criterion validity (correlation)
timeFrame: Both scales (PASIPD-Fr and Dijon PAS) were filled-out in a single point of time within a period of time of 12 months (study time frame)
measure: Criterion validity (discrimination)
timeFrame: Both scales (PASIPD-Fr and Dijon PAS) were filled-out in a single point of time within a period of time of 12 months (study time frame)
measure: Test-retest reliability
timeFrame: The PASIPD-Fr was administered twice at a 2-week interval within a period of time of 12 months (study time frame)
Secondary outcomes:
measure: Construct validity 10TMWT
timeFrame: Both PASIPD-Fr questionaire and 10MWT test were assessed in a single point of time within a period of time of 12 months (study time frame)
measure: Construct validity ABC-S
timeFrame: Both PASIPD-Fr questionaire and ABC-S scale were filled-out in a single point of time within a period of time of 12 months (study time frame)
measure: Construct validity HAD
timeFrame: Both PASIPD-Fr questionaire and HAD scale were filled-out in a single point of time within a period of time of 12 months (study time frame)
measure: Construct validity MOS SF12
timeFrame: Both PASIPD-Fr questionaire and MOS SF12 scale were filled-out in a single point of time within a period of time of 12 months (study time frame)
measure: Internal consistency
timeFrame: The PASIPD-Fr scale was filled-out in a single point of time within a period of time of 12 months (study time frame)
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU Caen Normandie
Study officials:
References: