- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06133608
Kinesiophobia and Fear of Falling After Femur Fracture
The Effect of Mobilization Training on Kinesiophobia and Fear of Falling in Patients Undergoing Hip Arthroplasty After Femur Fracture
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
As a result of the changes that occur in old age, individuals face different problems and risks more frequently than the younger age group. One of the most important among these is falls, which cause high mortality and morbidity in this age group. Hip fractures that occur after a fall are the most distressing injuries that elderly individuals experience. Hip arthroplasty is one of the treatment methods preferred by patients who have hip fractures after a fall. After hip arthroplasty, elderly patients may avoid mobilization due to the fear of falling and damaging the prosthesis. This can lead to restriction of activities and a decrease in functional independence. This avoidance behavior increases with the fear of falling. Avoidance of movement due to fear of falling is defined as "kinesiophobia". Studies have stated that mobilization training before or after hip arthroplasty surgery is effective in postoperative mobilization. For this reason, it is thought that providing mobilization training to patients undergoing hip arthroplasty surgery will lead to more success in mobilization.
This study will be conducted as intervention research to determine the effect of mobilization training to be provided to the patient undergoing hip arthroplasty on postoperative kinesiophobia and fear of falling. The project will be carried out with 50 voluntary patients (25 intervention, 25 control) aged over 65 who came to Hospital for hip arthroplasty after femur fracture, can communicate, have no advanced sensory loss related to vision and hearing, do not have a psychiatric history, and will undergo hip arthroplasty surgery for the first time. Data will be collected using a "Sociodemographic Characteristics Questionnaire", the "Tampa Scale for Kinesiophobia", and "the Fall Activity Scale". Appropriate statistical methods will be used in the analysis of the data. Patients in the control group will be given routine care during the study. Patients in the experimental group will receive technology-assisted mobilization training in addition to routine care. Before mobilization, a training video loaded into a tablet will be given to patients. Written permission will be taken from the ethics committee and the institution for the implementation of the research and written consent will be obtained from the patients.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients who will undergo hip prosthesis due to femur fracture after a fall,
- Patients who were mobilized before falling,
- Being over 65 years of age
- Volunteering to participate in the research
- No previous hip arthroplasty
- Ability to read and write
- There is no perception disorder or psychiatric disorder that would hinder communication.
Exclusion Criteria:
- Having difficulty in communicating
- Severe sensory loss related to vision and hearing
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental
Patients in the intervention group will be educated by watching videos on the first day after surgery, in addition to routine clinical education.
On the 10th post-operative day, the patients will be called by the researcher and the "Tampa Kinesiophobia Scale" and "Fall Activity Scale" will be administered.
|
Things to consider in the hospital in the early period after surgery: The first day in the hospital after surgery, the importance of the abduction pillow and early mobilization,
|
|
No Intervention: Control
The control group will receive routine clinical training.
On the 10th post-operative day, the patients will be called by the researcher, and the "Tampa Kinesiophobia Scale" and "Fall Activity Scale" will be administered.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tampa Scale for Kinesiophobia
Time Frame: 10 days
|
Tampa Scale for Kinesiophobia is a 17-question checklist and is used for acute and chronic low back pain, fibromyalgia, and diseases associated with musculoskeletal injuries and whiplash.
A 4-point Likert scoring (1 = Strongly disagree, 4 = Completely agree) is used in the scale.
A total score is calculated after reversing items 4, 8, 12 and 16.
The person receives a total score between 17-68.
A high score on the scale indicates that the person has a high level of kinesiophobia.
Permission was obtained from the researchers for the use of the scale.
|
10 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KastamonuU2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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