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Clinical Trials/NCT06018610
NCT06018610
Completed
Not Applicable

Mid-term Efficacy and Results of Postoperative Relaxation and Underfloor Classical Massage Methods and Training in Proximal Femur Fractures

Muğla Sıtkı Koçman University2 sites in 1 country40 target enrollmentMay 18, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fracture of Femur
Sponsor
Muğla Sıtkı Koçman University
Enrollment
40
Locations
2
Primary Endpoint
Sole sensory testing with Semmes-Weinstein Monofilament
Status
Completed
Last Updated
4 months ago

Overview

Brief Summary

The study will be conducted with volunteer patients who are followed up by the Orthopedics and Traumatology Service of Muğla Sıtkı Koçman University Training and Research Hospital and who have undergone proximal femur fracture surgery and meet the study criteria. It is aimed to investigate the mid-term efficacy of relaxation exercises and classical massage of the sole of the foot applied in addition to the conventional physiotherapy program in the postoperative in-hospital period in patients with proximal femur fracture.

Registry
clinicaltrials.gov
Start Date
May 18, 2022
End Date
October 1, 2025
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Muğla Sıtkı Koçman University
Responsible Party
Principal Investigator
Principal Investigator

Fatih Ozden

Assistant Professor

Muğla Sıtkı Koçman University

Eligibility Criteria

Inclusion Criteria

  • Male and female patients aged 50 years and older who were diagnosed with proximal femur fracture and underwent surgery
  • No medical contraindications that would limit the ability to exercise
  • Having a caregiver who can supervise the exercise program after discharge
  • To be able to understand simple commands and to have signed the consent form

Exclusion Criteria

  • Patients with pathological fractures and/or multiple fractures
  • Those with serious early complications
  • Terminally ill patients
  • Circumstances that would interfere with conducting assessments or communicating
  • Lack of cooperation during the study
  • Scoring ≤14 on the Mini Mental State Examinatio

Outcomes

Primary Outcomes

Sole sensory testing with Semmes-Weinstein Monofilament

Time Frame: Change from Baseline Semmes-Weinstein Monofilament Test at 3 days

The filament is imposed horizontally against the skin until there is a visible bending of the fiber. The patient then verbally assesses whether the sensation is perceived. Starting with the thinnest filament, thick filament is used sequentially until the patient feels it.

Hospital Anxiety and Depression Scale (HADS)

Time Frame: Change from Baseline HADS at 3 days

The HADS consists of two subscales, one with seven items measuring anxiety and the other with seven items measuring depression, which are scored separately. Each item is answered by the patient on a 4-point response category (0 to 3), so that possible scores range from 0 to 21 for anxiety and 0 to 21 for depression. 0 to 7 is considered "normal", 8 to 10 "mild", 11 to 14 "moderate" and 15 to 21 "severe".

Nottingham Hip Fracture Score (NHFS)

Time Frame: Change from Baseline NHFS at 3 days

The Nottingham Hip Fracture Score is an aggregate score of seven preoperative variables that gives an estimated risk of 30-day postoperative mortality using a standard logistic regression. This score is calculated based on age, gender, comorbidities, place of residence (i.e. home or institutional care), abbreviated mental test score (AMTS) and hemoglobin level at admission. Higher scores indicate better condition.

Barthel Index (BI)

Time Frame: Change from Baseline BI at 3 days

The Barthel Index was developed as a measure to assess disability in patients with neuromuscular and musculoskeletal disorders undergoing inpatient rehabilitation. A maximum total score of 100 can be obtained. Higher score indicates better condition.

EQ-5D-3L Quality of Life Scale

Time Frame: Change from Baseline EQ-5D-3L at 3 days

The EQ-5D-3L provides information on three aspects of quality of life. Each dimension has three levels of impairment: no problems (level 1), some problems (level 2) and extreme problems (level 3). The score ranges from less than 0 to 1 (where 0 is a health status equivalent to death and negative values are worse than death) and 1 is the most positive score (the best perceived level according to the five dimensions included in the scale). Finally, the EQ VAS score is obtained by asking patients to rate their health status on a 20 cm vertical scale. The scale ranges from 0 to 100, with 0 meaning "worst imaginable health" and 100 meaning "best imaginable health".

Tampa Scale for Kinesiophobia (TSK)

Time Frame: Change from Baseline TSK at 3 days

The questionnaire is a 17-item scale developed to measure fear of movement/reinjury. The normal score range is between 17 and 68.

Visual Analog Scale (VAS)

Time Frame: Change from Baseline VAS at 3 days

On a 10 cm straight line or numeric scale, the patient is asked to mark the pain they feel (0: no pain, 10: excruciating pain).

Study Sites (2)

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