NCT06009419

Brief Summary

This study was planned to investigate the effectiveness of usual care and dual task program in patients who underwent total hip arthroplasty surgery. It is aimed to evaluate pain intensity, disability level, mini mental status, coordination, 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 Muğla Training and Research Hospital and who have undergone total hip arthroplasty surgery. The evaluations will be performed in the Orthopedics and Traumatology outpatient clinic of Muğla Training and Research Hospital. It is aimed to evaluate at least 24 patients for the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

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
2 months until next milestone

Study Start

First participant enrolled

October 25, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2024

Completed
Last Updated

May 1, 2024

Status Verified

April 1, 2024

Enrollment Period

6 months

First QC Date

August 19, 2023

Last Update Submit

April 29, 2024

Conditions

Outcome Measures

Primary Outcomes (9)

  • 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

  • Cognitive Timed Up and Go Test (CTUG)

    Patients are first asked to stand up from a sitting position, walk 3 m at their normal speed, turn around, walk back to the chair and sit down. Walking aids are allowed. Patients are asked to perform this test while performing a cognitive dual task (subtract 2 continuously starting from 100).

    Change from Baseline CTUG at 8 weeks

  • Dual-Task Questionnaire (DTQ)

    The questionnaire consists of 10 items and each question is rated out of 5 points (ranging from 0 "never" to 4 "very often" or N/A "not applicable"). The score obtained is the average score per question (i.e. total score/10 for the questionnaire).

    Change from Baseline DTQ at 8 weeks

  • Activity Specific Balance Confidence Scale (ABC)

    This scale includes 16 tasks related to indoor and outdoor activities of daily living to measure balance confidence in older people with various levels of function. Scores for each question range from 0% (no confidence) to 100% (full confidence). Higher scores indicate greater confidence.

    Change from Baseline ABC at 8 weeks

  • 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

  • Harris Hip Score (HHS)

    The HHS contains 12 questions covering four domains: pain (44 points); function (47 points); deformity; and range of motion (9 points). This questionnaire was developed to assess the outcomes of young and middle-aged patients following hip arthroscopic debridement. Each question is answered using a Likert scale with an overall score ranging from 0 (extreme symptoms) to 100 (no symptoms).

    Change from Baseline HHS at 8 weeks

  • Mini-Mental State Examination (MMSE)

    The mini mental test is categorized under five main headings: orientation (10 points), recording memory (3 points), attention and calculation (5 points), recall (3 points) and language (9 points). The scale is scored out of a total of 30 points and has two different variants for educated and uneducated people. Traditionally, scores between 24 and 30 are considered normal. A score below 24 indicates cognitive impairment. 18-23 is considered as mild dementia, 12-17 as moderate dementia and below 12 as severe dementia.

    Change from Baseline MMSE at 8 weeks

  • Lower-Extremity Motor Coordination Test (LEMOCOT)

    The test requires subjects seated in a chair to alternately touch a proximal and distal target placed 30 cm apart on the floor with their feet within a 20-second period. A higher score indicates better motor coordination.

    Change from Baseline LEMOCOT at 8 weeks

  • 4-Meter Gait Speed (4MGS)

    Walking speed is assessed over two trials using a stopwatch in a long corridor over a distance of 4 meters during a single testing session, with one trial performed immediately after the other. Participants start ambulating approximately two meters before the start of the timed 4-meter walk and stop ambulating approximately two meters after completing the 4-meter walk. Timing begins and ends when the participants' lead foot crosses the start and end points of the 4-meter walk, respectively. Participants are instructed to walk at their normal safe walking speed and are allowed to use an assistive device if needed. The time taken to complete the two ambulation trials is recorded for analysis. Walking speed is calculated as the distance walked (4 meters) divided by the time taken to complete the 4-meter walk. The average walking speed for the two trials is calculated.

    Change from Baseline 4MGS at 8 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

In addition to the program given to the control group, the dual task program will be progressively given to the study group as previously described (Silsupadol et al., 2006). These applications will be explained to the patients or their relatives face-to-face in the clinical environment after the initial evaluation and then sent and followed up by telerehabilitation method and patients will always have access to programs and education. In addition, both groups will be told that they can contact the researcher upon request.

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 a dual task program 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 Sıtkı Koçman Training and Research Hospital

Muğla, Menteşe, 48000, Turkey (Türkiye)

Location

Related Publications (1)

  • Uysal I, Ozden F, Yalcin M, Isik EI, Sari Z. The effect of dual-task training in older adults with total hip arthroplasty: a randomized controlled trial. BMC Musculoskelet Disord. 2025 Jan 8;26(1):29. doi: 10.1186/s12891-025-08279-7.

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

October 25, 2023

Primary Completion

April 20, 2024

Study Completion

April 25, 2024

Last Updated

May 1, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations