NCT06009432

Brief Summary

This study was planned to investigate the effectiveness of usual care and additional proprioceptive neuromuscular facilitation exercise program in patients undergoing total hip arthroplasty surgery. It is aimed to evaluate pain intensity, disability level, proprioception, kinesiophobia, balance and functional status of the patients. The study will be conducted with volunteer patients who are followed up by the Orthopedics and Traumatology outpatient clinic of Fethiye State Hospital and who have undergone total hip arthroplasty surgery. The evaluations will be performed in the Orthopedics and Traumatology outpatient clinic of Fethiye State Hospital. It is aimed to evaluate at least 42 patients for the study. The first evaluation will be performed 6 weeks post-operatively and the second evaluation will be performed 2 months after treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
completed

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

August 19, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 24, 2023

Completed
1 year until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 15, 2025

Status Verified

December 1, 2025

Enrollment Period

1.1 years

First QC Date

August 19, 2023

Last Update Submit

December 7, 2025

Conditions

Outcome Measures

Primary Outcomes (8)

  • Visual Analog Scale (VAS)

    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).

    Change from Baseline VAS at 8 weeks

  • Western-Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Functionality level in the patient group with knee OA was measured using WOMAC. WOMAC consists of 3 main headings: pain intensity, stiffness and physical function. The individuals included in the study are asked to score each item between 0 (no pain, stiffness, difficulty) and 5 (very severe pain, stiffness, difficulty). The total score ranges from 0 (no disability) to 96 (complete disability).

    Change from Baseline WOMAC at 8 weeks

  • 3 Meter Backward Walk Test (3MBWT)

    A distance of 3 meters is measured and marked. Children are asked to walk backwards safely when the signal is given and stop when they reach the marked point. They are allowed to look behind them if necessary. Measurements are repeated 3 times and the average time is recorded.

    Change from Baseline 3MBWT at 8 weeks

  • One Leg Standing Test (OLST)

    The subject is tested standing on one leg using the right and left legs respectively. The test is repeated on a hard surface with eyes open and closed. The subject is asked to place both hands on the hips and look at a target on the wall at eye level at a distance of 1 meter. The subject is asked to stand with one leg in a 90 degree flexion position and the other leg in a standing position. A stopwatch is used to record the time the subject can maintain the test position. If the subject can hold the position for more than 30 seconds, the test is terminated and the elapsed time is recorded.

    Change from Baseline OLST at 8 weeks

  • Five Times Sit to Stand Test (5TSST)

    A chair without armrests, with a 28.5 cm deep seat and backrest and adjustable height is used for the tests. Subjects start in a seated position, with their arms in the desired position and their backs against the chair backrest. The following verbal instructions are given: "Please stand up and sit down 5 times as quickly as possible. Straighten your knees when standing up and lean your back against the backrest when sitting down." Timing with the digital stopwatch is started manually with the instruction "Start" and stopped when the subject's back touches the backrest after the fifth standing up.

    Change from Baseline 5TSST at 8 weeks

  • Fear-Avoidance Beliefs Questionnaire (FABQ)

    The FABQ consists of 16 items and is divided into 2 subscales. The items are scored on a 7-point Likert scale (from strongly disagree to strongly agree). The score of each subscale is used independently. Higher scores represent more fear avoidance beliefs.

    Change from Baseline FABQ at 8 weeks

  • Falls Efficacy Scale International (FES-I)

    The FES-I is a self-report questionnaire, providing information on level of concern about falls during activities of daily living. The questionnaire contains 16 items scored on a four-point scale (1 = not at all concerned to 4 = very concerned) providing a total score ranging from 16 (absence of concern) to 64 (extreme concern).

    Change from Baseline FES-I at 8 weeks

  • Hip joint proprioception measurement

    Patients were placed in a supine position and blindfolded to eliminate visual cues. The test started at neutral position (0°) and patient actively fexed the hip toward the fexion target position of 45°, which was indicated by a mechanical obstruction. After holding that position for 5 s, patient focused and remembered the angle, and brought the joint actively back to the neutral starting position. Then, patient was asked to actively reproduce the target position without the mechanical obstruction and hold at where he/she felt it was the just position. Five repetitions were performed for each leg and "absolute angular error" values were obtained from the start and stop angles.

    Change from Baseline proprioception measurement at 8 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

In addition to the program given to the control group, the study group will be given proprioceptive neuromuscular facilitation exercise as previously described (Smedes et. al., 2021). These applications will be applied to the patients for 8 weeks, 2 days a week in the clinical environment after the initial evaluation. In addition, both groups will be told that they can contact the researcher when requested.

Other: Rehabilitation

Control Group

ACTIVE COMPARATOR

The control group will receive the usual post-operative care of stretching lower extremity strengthening balance exercises activities of daily living recommendations.

Other: Rehabilitation

Interventions

The control group will receive the usual post-operative care of stretching, lower extremity strengthening, balance exercises, activities of daily living recommendations. The study group will be given proprioceptive neuromuscular facilitation exercise in addition to the program given to the control group.

Control GroupIntervention Group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having undergone unilateral total hip arthroplasty surgery and being 6 weeks postoperative
  • Participate in all necessary follow-up assessments
  • years of age or older
  • Understand simple commands
  • Signing the consent form

You may not qualify if:

  • A previous history of total hip arthroplasty
  • Presence of revision surgery
  • Presence of severe osteoarthritis in the contralateral hip
  • Severe acute metabolic neuromuscular and cardiovascular diseases
  • Severe obesity (bki\>35)
  • Presence of malignancy
  • Have any other orthopedic or neurological problem that may affect treatment and assessments
  • Situations that prevent communication
  • Lack of cooperation during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muğla

Muğla, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Rehabilitation

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Fatih Özden, PhD

    Muğla Sıtkı Koçman University

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 19, 2023

First Posted

August 24, 2023

Study Start

September 1, 2024

Primary Completion

October 1, 2025

Study Completion

December 1, 2025

Last Updated

December 15, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations