Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05103930 |
| Other study ID # |
InnovationForParticipation |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 11, 2019 |
| Est. completion date |
December 31, 2019 |
Study information
| Verified date |
March 2022 |
| Source |
University Hospital, Brest |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Children with disabilities experience activities limitations and participation restrictions.
Facilitating the children with disabilities' independence while performing tasks is a key
stake to improve their successful participation and their development.
Products and technology can prevent, compensate, relieve or neutralize disability or handicap
and help children and youth with disabilities to perform tasks that might otherwise be
difficult or impossible.
The aim of this study was i) to identify the most frequent activity limitations and
participation restrictions for which assistive products and technology may be useful for
children and youth with disabilities, and ii) to highlight macroscopic trends related to
encountered difficulties and wished products and technology.
The hypotheses were i/ that difficulties would be particularly expected for certain life
situations, especially outside the home in an unfamiliar environment ii/ that products and
technology would be wished for those situations which should be defined as priority subjects
and iii/ that thanks to those results it could be possible to highlight new processes to
develop innovative solutions.
Description:
The study was conducted according to current French legislation (loi Jardé (n°2012-300).It
was a cross-sectional study with a convergent parallel mixed method design. It used an online
open survey following the STROBE and CHERRIES guidelines. A tailored survey with closed and
open questions was used to obtain complementarity data on the topic i.e. to identify the most
frequent life situations for children with disabilities for which a product or technology
could be useful and drill deeper in these situations with responders' personal experiences to
characterize those situations and identify wished solutions.
Survey's development The survey was developed by a group involving three Physical Medicine
and Rehabilitation physicians and two occupational therapists. The conceptual framework of
the ICF (International Classification of Functioning, Disability and health) which recognizes
the role of environmental factors in the creation of disability was used. The survey was
pilot tested by two mothers of children with disabilities and an adult who has had a
disability since childhood. Comments were considered to improve the survey in a second
version.
It was developed using an online tool (google form). Three versions were developed targeting
the three participant profiles: persons with childhood onset disabilities, their relatives
and the professionals who work with them. Each version was composed of 14 to 16 questions (in
6 pages). Firstly, participants had access to a description of the study with a dedicated
picture so that making everyone aware of the project, and precising the general objective of
the study. Then, questions were asked on epidemiological data. In a second step, a closed
multiple-choice question was presented with a pre-established list of life situations of a
regular day. Responders had to select the life situations which they evaluated as the most
difficult for children with disabilities to be involved in. Respondents could tick as many
items as they wished. All items were extracted from validated scales ("Life H": assesment of
Life habits/ "ABILHAND assessment" / "ABILOCO KIDS"/ "PEDI": Paediatric Evaluation of
Disability Inventory / "ACTIVLIM-CP"). The list was proposed in a chronological order in
order to help the responder think of his own life. Then, open questions invited the
respondents to precise the ticked items. The first open question proposed to precisely
describe examples from the respondents' own experience (hereinafter referred to as
"difficulties") in regular weekdays. Then they had to describe wished strategies that could
allow an improvement (hereinafter referred to as "solutions"). Eventually, these last three
questions were repeated but dealing with weekend and holidays situations instead of regular
weekday situations. The survey was conceived to be short and take less than 10 minutes.
Respondents could review and change their answers. No completeness check was proposed.
Responders could not be identified from the survey (no identity data, no email or Internet
Protocol (IP) address), thus anonymity was guaranteed.
Survey's distribution Participants were surveyed through convenience and snowball sampling to
obtain data from participants with a wide range of situations between March and December
2019. The survey was promoted in France through "SFERHE" (Société Francophone d'Etudes et de
Recherche sur les Handicaps de l'Enfance) and through the "EACD" (European Academy of
Childhood Disability). A leaflet was prepared to present the project. It was posted in
hospitals and distributed on social media (Linked in, Facebook, Twitter), and by e-mail. To
facilitate the diffusion, the survey was addressed to families and patients' organisations
(FFAIMC, "Fondation PC", "AFM"), professional networks ("réseaux maladies rares") and
directly promoted during professional events (e.g. "EACD 2019 Paris", "SOFMER 2019
Bordeaux"). Participants answered voluntarily, no incentive was proposed.
