BACKGROUNG In Italy there are still few translated and validated instruments to assess
participation.
In the field of pediatric rehabilitation, among the tools available internationally, one
of the most comprehensive and widely used is the Assessment of Life Habits, or LIFE-H,
now in its 4.0 version. The LIFE-H scale was originally developed in French and
implemented by the International Network on the Disability Creation Process - INDPC, also
known as the Quebec Model or Handicap Creation Process.
Internationally, the "LIFE-H" scale has been translated and validated in several
languages. The scale is among the most comprehensive and detailed instruments in the
literature: it consists of 90 items (life habits), divided into 12 domains, 6 of which
are for regular activities (e.g., communication and mobility), and 6 for social roles
(responsibility and interpersonal relationships).
A study of Italian translation and cultural adaptation of the LIFE-H scale 4.0 for
children aged 5 to 13 years, was carried out during 2020-2021.
The scale and its related user manual in Italian version have also been insert into the
platform of the Canadian originator company "Réseau international sur le Processus de
production du handicap" - RIPPH).
AIM The goal of the study is to assess the intra- and inter-rater reliability, internal
consistency and construct validity of the scale in its Italian version.
METHOD Participants will be recruited from the pediatric rehabilitation centers of
Toscana Centro , AOU Meyer IRCCS and AORN Santobono-Pausilipon Subjects interviewed will
be caregivers of children with disabilities between the ages of 5 and 13 years.
Care-givers of children with physical, sensory and cognitive disabilities, regardless of
diagnosis, will be included in the study, as per the scale's user manual.
First Part Step 1: Presentation of the project through informational documentation to
pediatric rehabilitation physical therapists of the territorial services of Toscana
Centro and AOU Meyer IRCCS, who will identify candidate families for the study.
Step 2: Collection of informed consent by the investigating physical therapist in the
referral area.
Step 3: TEST: Administration of the LIFE-H 4.0 / 5-13 years scale by an investigator (FT
1). As stipulated among the modes of administration, the questionnaire will be completed
by the reference person or parent of the child with support from the experimenter. The
administration will be done via video call on Google Meet platform, which platform is
deemed most suitable in terms of use for families.
Step 4 : RETEST: After an interval of 15 days, second administration of the questionnaire
will be carried out in the same manner and by the same experimenter.
Step 5 : Analysis and comparison of the collected data. Second part Step 6: Making
contact with subjects who had adhered to both phases of the study (as indicated in the
informed consent signed in step one) and re-enrollment through informational
documentation to pediatric rehabilitation physical therapists from the territorial
services of Toscana Centro, AOU Meyer IRCCS, and AORN Santobono-Pausilipon, who will
identify candidate families for the study.
Step 7: Collection of informed consent from the investigating physical therapist in the
target area.
Step 8: TEST: Administration of the LIFE-H 4.0 / 5-13 years scale by an investigator (FT
3). As stipulated among the modes of administration, the questionnaire will be completed
by the reference person or parent of the child with support from the experimenter. The
administration will be done via video call on Google Meet which platform is deemed most
suitable in terms of family use.
Step 9: RETEST: Administration of the LIFE-H 4.0 / 5-13 years scale by an experimenter
(FT 4) 15 days apart in the same manner.
Step 10: To complete the validation process (Construct Validity), the PEM-CY
questionnaire will be provided to parents participating in the second phase of the study.
The instrument was chosen, among the few available in the Italian language, because of
features in common with the Life-H scale. The caregivers will be able to fill out the
paper version of the questionnaire themselves. The latter will be kept within the child's
medical record; the investigators will only be informed of the final score of the
questionnaire.
step 11: analysis and comparison of collected data SAMPLE SIZING AND STATISTICAL METHODS
OF DATA ANALYSIS With respect to the required sample size, contacts have been made with
the Canadian authors of the LIFE-H scale (International Network on the Disability
Creation Process - INDPC), who suggest a minimum minimum sample size of 30 subjects. Also
taking into consideration other scale validation articles, we therefore plan to enroll 30
subjects for Phase 1 (intra-operator concordance and internal consistency) and 130
subjects for Phase 2 (inter-operator concordance and construct validity of construct).
Analysis of the results of the LIFE-H questionnaire