Investigation of Sensory Processing Patterns of Elderly Individuals Who Have Had Hip Fracture Surgery

March 31, 2023 updated by: Sena Erarslan, Atlas University

Investigation of the Relationship Between Sensory Processing and Potential Impact Factors in Elderly Adults Receiving Hip Fracture Surgery for Falling

This study aims to evaluate the sensory processing processes of elderly adults who have undergone fall-related hip fracture surgery in the last 6 months, according to different patterns, and to examine the relationship between physical performance, fall risk, fear of falling, and depression parameters that may be related to sensory processing.

Study Overview

Status

Status

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

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.

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.
Observational

Enrollment (Anticipated)

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.
134

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • Kagıthane
      • Istanbul, Kagıthane, Turkey, 34403
        • Recruiting
        • Istanbul Atlas University
        • Contact:

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

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Older adult individuals who have suffered a fall and therefore undergo hip fracture surgery.

Description

Inclusion Criteria:

  • Being 65 years or older
  • Being able to stand independently for 30 seconds
  • Being able to walk 3 m independently (with an assistive device if necessary)
  • Getting a score of 24 or more on the Mini Mental Test

Exclusion Criteria:

  • Hip fracture patients receiving medical treatment for pathological hip fractures, polytrauma, traffic accidents, bone tumors
  • Having a history of diseases that may directly affect the evaluation process (neurological diseases such as Parkinson's, Alzheimer's and cancer)
  • Having vision and hearing loss
  • Having a psychiatric illness

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

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
Adult Sensory Processing Scale
Time Frame: 20 minutes
The Adult Sensory Processing Scale is a self-report tool developed to measure the response given to stimuli from different sensory systems in adults, sensitive to individual differences. Scale; evaluates different behavioral responses (overreaction, underreaction and sensory seeking) in five different sensory systems, namely tactile, proprioceptive, vestibular, visual and auditory, which are indicators of sensory processing difficulties. The scale consists of 11 factors and 48 items in total. All items are rated on a 5-point Likert scale as never = 1, rarely = 2, sometimes = 3, often = 4, and always = 5. While calculating the scale, the scores obtained from each factor are graded in 3 different categories: "typical range", "possible difficulty" and "exact difficulty".
20 minutes
Short Physical Performance Battery
Time Frame: 25 minutes
Short Physical Performance Battery, consists of 3 performance-based tests that evaluate standing balance, walking speed and sitting balance, and which are simple and faster to use clinically than other fall risk tools. The performance time of each performed task is recorded with a stopwatch. Each performance test is scored between 1-4. If the task given in the test cannot be completed, 0 points are recorded. A total score in the range of 0-12 is obtained by summing the scores of all performance areas. High scores mean good performance .
25 minutes
Timed Up and Go Test
Time Frame: 5 minutes
It is a practical and reliable measurement tool that evaluates fall risk and mobility in elderly individuals. During the test, the participant is sitting in a standard chair with a seat height of approximately 46 cm. With the therapist's start command, the participant is asked to get up from the chair, walk up to the marked distance of 3 meters, turn back and sit back in the chair. To measure performance, the elapsed time is recorded in seconds.
5 minutes
Falls Efficacy Scale
Time Frame: 10 minutes
Scale; It aims to evaluate the self-confidence of the individual in the realization of 10 activities that are relatively safe from daily life activities without falling. The individual is asked to give a score between 1 and 10 on a numerical scale for each activity. 1 point means I don't trust at all, 10 points means I trust very much and all points are added to get the total score of the test. The total score that can be obtained from the scale is in the range of 10-100. An increase in the score indicates the presence of less safe behaviors related to falling.
10 minutes
Geriatric Depression Scale
Time Frame: 15 minutes
The scale was specifically designed by Yesavage et al. The easy-to-understand, self-reported 30-item scale includes questions about affective changes, negative attitudes about the past, present and future, and withdrawal from life. By summing all the items, a total score ranging from 0-30 is obtained. It is reported that the risk of depression is high for older adults who score 14 points or more.
15 minutes

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.
Atlas 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.
February 27, 2023

Primary Completion (Anticipated)

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.
April 10, 2023

Study Completion (Anticipated)

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.
April 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).
March 31, 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.
March 31, 2023

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.
April 13, 2023

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.
April 13, 2023

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.
March 31, 2023

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.
March 1, 2023

More Information

Terms related to this study

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.
  • SErarslan2023-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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