NCT06133608

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

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

First Submitted

Initial submission to the registry

November 8, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 15, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 2, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

November 15, 2023

Status Verified

November 1, 2023

Enrollment Period

5 months

First QC Date

November 8, 2023

Last Update Submit

November 13, 2023

Conditions

Keywords

Fear of movingFear of falling

Outcome Measures

Primary Outcomes (1)

  • Tampa Scale for Kinesiophobia

    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

Study Arms (2)

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.

Other: MOBILIZATION TRAINING

Control

NO INTERVENTION

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.

Interventions

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, * Exercises performed in bed in the early period after surgery: Exercises such as ankle pump, ankle rotation, bed-supported knee bending, hip contraction, opening exercise, thigh exercise, straight leg raise, * Early standing up: Activities such as sitting in bed or on a chair, standing up with the help of a walker, walking, * Exercises performed while standing: Exercises such as lifting the knee, opening the leg to the side, * Daily living activities: It will provide information on regulating ADLs such as bathing, dressing, using the toilet, getting into and driving the car, going up and down stairs, eating, sleeping, doing housework, sexual life, and information about the safety precautions that should be taken at home.

Experimental

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Having difficulty in communicating
  • Severe sensory loss related to vision and hearing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 8, 2023

First Posted

November 15, 2023

Study Start

January 2, 2024

Primary Completion

June 5, 2024

Study Completion

December 20, 2024

Last Updated

November 15, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share