NCT05811559

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2023

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2023

Completed
Last Updated

April 13, 2023

Status Verified

March 1, 2023

Enrollment Period

1 month

First QC Date

March 31, 2023

Last Update Submit

March 31, 2023

Conditions

Outcome Measures

Primary Outcomes (5)

  • Adult Sensory Processing Scale

    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

    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

    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

    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

    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

Interventions

No intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Atlas University

Istanbul, Kagıthane, 34403, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Sensation DisordersHip FracturesHypersensitivity

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesImmune System Diseases

Central Study Contacts

Sena Erarslan, Master

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 31, 2023

First Posted

April 13, 2023

Study Start

February 27, 2023

Primary Completion

April 10, 2023

Study Completion

April 20, 2023

Last Updated

April 13, 2023

Record last verified: 2023-03

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