Investigation of Palpation Pressure Sensitivity

February 9, 2024 updated by: Ömer Osman Pala, Abant Izzet Baysal University

Investigation of Palpation Pressure Sensitivity of Physiotherapists

The study is planned for searching physiotherapists palpation abilities. There were 2 groups of physiotherapists. They were asked for to push target pressures. After making some exercise, the assesment was done again.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

2 groups of physiotherapists with different fields of experience were attended to study. Fingers are positioned on the marked area at the center point of the scale. Therapists were asked to apply pressure to the scale with estimated weights of 0.5 kg, 1 kg, 2 kg and 4 kg. In each measurements, the value on the scale was recorded without being shown to the participants. After the measurements, the participants were made to experiment when the digital screen can be seen, in order to teach the physiotherapists how much pressure they applied to reach the target weight. Participants were given a total of 10 minutes for the trials. Then, the digital screen was hidden again, and the therapist was asked to apply 0.5 kg, 1 kg, 2 kg and 4 kg weight in a randomized order and maintain that pressure for 5 seconds. The weight fixed by the therapist for 5 seconds was noted by the researcher; the participant was not informed about the values on the digital screen.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
63

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Bolu, Turkey, 14300
        • Faculty of Health Sciences Bolu Abant Izzet Baysal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Willing to participate,
  • Active working patients as a physiotherapists pediatric, neurologic, orthopedic physiotherapy, manual therapy or osteopathy.

Exclusion Criteria:

  • Having a neurological disease (multiple sclerosis, polyneuropathy, etc.) -Having a disease that may cause neurological deficit in the upper extremity (cervical myelopathy, carpal tunnel syndrome, pronator teres syndrome, cubital tunnel syndrome, ---
  • Guyon canal syndrome)
  • Refuse to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Manual Therapy using group
This group includes physiotherapists that using manual therapy techniques.
Other: Pressure sensitivity education
Therapists were asked to apply pressure to the scale with estimated weights of 0.5 kg, 1 kg, 2 kg and 4 kg. In each measurement, the value shown on the scale was recorded without being shown to the participant.After the measurements, the participants were made to experiment when the digital screen can be seen, in order to teach the physiotherapists how much pressure they applied to reach the target weight. Participants were given a total of 10 minutes for the trials. Then, the digital screen was hidden again, and the therapist was asked to apply 0.5 kg, 1 kg, 2 kg and 4 kg weight in a randomized order and maintain this pressure for 5 seconds. The weight fixed by the therapist for 5 seconds was noted by the researcher; the participant was not informed about the values on the digital screen.
Experimental: Non Manual Therapy using
This group includes physiotherapists using different techniques during working, not manual therapy
Other: Pressure sensitivity education
Therapists were asked to apply pressure to the scale with estimated weights of 0.5 kg, 1 kg, 2 kg and 4 kg. In each measurement, the value shown on the scale was recorded without being shown to the participant.After the measurements, the participants were made to experiment when the digital screen can be seen, in order to teach the physiotherapists how much pressure they applied to reach the target weight. Participants were given a total of 10 minutes for the trials. Then, the digital screen was hidden again, and the therapist was asked to apply 0.5 kg, 1 kg, 2 kg and 4 kg weight in a randomized order and maintain this pressure for 5 seconds. The weight fixed by the therapist for 5 seconds was noted by the researcher; the participant was not informed about the values on the digital screen.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Measurement Palpation Pressure with Digital Scale
Time Frame: baseline
The digital scale will used to assess the palpation pressure of participants. This digital scale is designed for a measurement range of 1-10.000 gr. Palpation pressures will measure at baseline and after education to see whether any changes.
baseline
Measurement Palpation Pressure with Digital Scale
Time Frame: 10 minute after pressure sensitivity education
The digital scale will used to assess the palpation pressure of participants. This digital scale is designed for a measurement range of 1-10.000 gr. Palpation pressures will measure at baseline and after education to see whether any changes.
10 minute after pressure sensitivity education

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abant Izzet Baysal University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ömer Osman Pala, Assoc. Prof, Abant Izzet Baysal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 3, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 16, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 20, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AIBU-FTR-OOP-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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