Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05285150 |
| Other study ID # |
6550 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2022 |
| Est. completion date |
February 28, 2023 |
Study information
| Verified date |
February 2023 |
| Source |
Hospital de Rehabilitacion Manuel Rocca |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Summary Introduction: Falls are involuntary events that cause loss of balance and hit the
body on the ground or on another firm surface that stops it. 40% of people with various
neurological disorders fall one or more times, and of all these, 21% suffer a fall-related
injury. Objective and instrumented gait analysis is an important tool for estimating the risk
of falls in patients.
Objective: To describe the protocols used by physical therapist residing in Argentina when
categorizing a balance problem within the framework of neurorehabilitation, vestibular
rehabilitation, geriatrics and gerontology. Identify the barriers and facilitators
self-perceived by physical therapist that make it difficult to weight deficiencies in
balance.
Method: An observational, descriptive, cross-sectional study of the online survey type will
be carried out. The recommendations given by the Checklist for Reporting of Survey Studies
will be used. The survey, which was created by the researchers of this study, will consist of
26 items divided into 4 sections. It will be aimed at all those physical therapist in
Argentina who are dedicated to neurorehabilitation, vestibular rehabilitation, geriatrics and
gerontology. The type of sampling used will be non-probabilistic by snowball, which will be
done online through the SurveyMonkeyTM tool.
Description:
Materials and method Study design An observational, descriptive, cross-sectional study will
be carried out. For its future report, the recommendations given by the Checklist for
Reporting of Survey Studies (CROSS) will be used.
Sample Characteristics All those physical therapist and related degrees dedicated to
neurorehabilitation/vestibular rehabilitation/geriatrics and gerontology who practice in
Argentina and who have experience in weighing balance deficiencies in subjects at risk of
falling will be included. All surveys with missing data will be excluded. The type of
sampling used will be non-probabilistic by snowball.
Data collection methods The online type survey which was created by the researchers of this
study, will be made up of 25 items divided into 4 sections, a restriction will be created in
each item to prevent respondents from leaving it without answering and those who have met all
the inclusion criteria will access it.
- The first section (respondent characteristics) consists of 10 questions.
- The second section (weighting performed by the respondent) is made up of 12 questions.
Those participants who choose the "no" option in question 11 will go on to the next
section.
- The third section (self-perception of barriers and facilitators at the time of
weighting) is made up of 2 questions.
- The fourth section (learning needs) consists of a question. Within the second section,
the choice of scales was made based on a previous search in the literature about those
that are most used, which to date have not been translated or adapted cross-culturally
into Argentine Spanish, most of them. the same It will be aimed at all those physical
therapist in Argentina who are dedicated to neurorehabilitation, vestibular
rehabilitation, geriatrics and gerontology. With this purpose, a pilot test was carried
out prior to the beginning of the study with the objective of the viability and
understanding of the survey, it was carried out with 10 experts in the area. They were
given a sheet with questions aimed at finding out the difficulties they encountered when
answering the survey in general or with a particular question. Modifications were made
through consensus among the authors.
Survey Administration You will be invited to participate in the study by sending the survey
via email and through social network links (FacebookTM, TwitterTM, InstagramTM, LinkedinTM
and WhatsappTM). The invitation will be given to specialized groups in the area,
specialization careers, physical therapy colleges in the country and the Argentine
association of kinesiology. The invitation will contain the objective of the study and its
corresponding link to access the survey, which will be online through the SurveyMonkeyTM
tool.
The period in which the current link will be maintained will be 2 months or until the
required sample size is reached. To avoid multiple participation of participants, the same
tool to be used (SurveyMonkeyTM) prevents double completion when using the same device. In
addition, a restriction will be applied to each question, thus preventing them from leaving
unanswered answers.
Sample size The required sample size will be 400 participants, since the accepted level of
error will be 5%. In turn, an analysis divided by half of the consistency will be carried
out, in order to determine if the results obtained are reliable or not.
Study Preparation Prior to the activation of the survey link, contact will be made throughout
the previous month in different institutions and experts on the subject, with the aim of
increasing the degree of knowledge and interest in it at the time of the start of the study.
Contact will be made through emails and different social networks (FacebookTM, TwitterTM and
InstagramTM).
Ethical considerations Given the voluntary and anonymous nature of the study, the signature
of the informed consent of the participants will not be required, as established by
resolution 1480/2011. Before accessing the questionnaire, participants will receive an
information sheet that will include study information, investigator contact information, a
privacy statement, and a statement regarding voluntary participation. At all times, the
protection of the identity and data of the study participants will be preserved, in
accordance with current legal regulations National Law on Protection of Personal Data 25326,
in accordance with international regulations in accordance with the provisions of the
Declaration of Helsinki.
