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Physical TherapyNCT05285150

The Weighting of the Balance

An observational study of Physical Therapy and Survey, run by Hospital de Rehabilitacion Manuel Rocca at 1 site in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 23 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Physical Therapy, Survey, Balance
What is being tested?
Survey
How many people
205 participants
Where
1 siteArgentina
Study dates
1 Dec 2022to 28 Feb 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 23 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Physical therapist in Argentina who are dedicated to neurorehabilitation, vestibular rehabilitation, geriatrics and gerontology who practice in Argentina

Who may be able to join

  • Physical therapist in Argentina who are dedicated to neurorehabilitation, vestibular rehabilitation, geriatrics and gerontology.
  • Practice in Argentina.
  • Have experience in weighing balance deficiencies in subjects at risk of falling

Who cannot join

  • All surveys with missing data will be excluded

Trial locations and contacts

1 site in 1 country.

Argentina1 site
  • Hospital Rocca

    Buenos Aires, 1079

Other trials in Argentina

About this study

Official title: Weighting of Balance Deficiencies Performed by Physical Therapist in Argentina in Subjects With Risk of Falling

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.

Read the detailed 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.

Being tested
Survey
Keywords
Physical Therapy, Survey, Balance, Assessment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurveyOther

    It´s a survey

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Balance assessment

    It will be measured through the self-report of the respondent whether or not they use a standardized scale or clinical observation with their patients. The variable will be categorized as dichotomous qualitative and the response options will be yes or no.

    Measured: 2022

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2022
  2. Study start1 Dec 2022
  3. Primary completion30 Jan 2023
  4. Study completion28 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
205 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05285150
Sponsor's protocol ID
6550
Status last verified
Feb 2023
First submitted
4 Mar 2022
Last updated
28 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Physical Therapy and Survey, run by Hospital de Rehabilitacion Manuel Rocca at 1 site in Argentina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Balance assessment (time frame: 2022). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.

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