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.
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.
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.
- Conditions
- Physical Therapy, Survey, Balance, Assessment
- 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.
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.
- First posted17 Mar 2022
- Study start1 Dec 2022
- Primary completion30 Jan 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hospital de Rehabilitacion Manuel Rocca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerardo Candoni, Hospital de Rehabilitacion Manuel Rocca
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weighting of Balance Deficiencies Performed by Physical Therapist in Argentina in Subjects With Risk of Falling
- ClinicalTrials.gov ID
- NCT05285150
- Acronym / sponsor ID
- 6550
- Conditions
- Physical Therapy, Survey, Balance, Assessment
- Keywords
- Physical Therapy, Survey, Balance, Assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Hospital de Rehabilitacion Manuel RoccaUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 23 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Physical therapist in Argentina who are dedicated to neurorehabilitation, vestibular rehabilitation, geriatrics and gerontology who practice in Argentina
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- All surveys with missing data will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyIt´s a survey | Other | – |
Primary outcome
Balance assessment
Time frame: 2022
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.