- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05811559
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
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
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
- Name: Sena Erarslan, Master
- Phone Number: +90 5301017555
- Email: erg.senaerarslan@gmail.com
Study Locations
-
-
Kagıthane
-
Istanbul, Kagıthane, Turkey, 34403
- Recruiting
- İstanbul atlas university
-
Contact:
- Sena Erarslan, Master
- Phone Number: +90 5301017555
- Email: erg.senaerarslan@gmail.com
-
-
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
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
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
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)
February 27, 2023
Primary Completion (Anticipated)
April 10, 2023
Study Completion (Anticipated)
April 20, 2023
Study Registration Dates
First Submitted
March 31, 2023
First Submitted That Met QC Criteria
March 31, 2023
First Posted (Actual)
April 13, 2023
Study Record Updates
Last Update Posted (Actual)
April 13, 2023
Last Update Submitted That Met QC Criteria
March 31, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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