- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06009419
Effectiveness of Dual Task Training in Total Hip Arthroplasty
April 29, 2024 updated by: Fatih Ozden, Muğla Sıtkı Koçman University
Effectiveness of Dual Task Training Versus Usual Care in Patients With Total Hip Arthroplasty: A Randomized Controlled Trial
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Menteşe
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Muğla, Menteşe, Turkey, 48000
- Muğla Sıtkı Koçman Training and Research Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Having undergone unilateral total hip arthroplasty surgery and being 6 weeks postoperative
- Participate in all necessary follow-up assessments
- 60 years of age or older
- Understand simple commands
- Signing the consent form
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control Group
The control group will receive the usual post-operative care of stretching lower extremity strengthening balance exercises activities of daily living recommendations.
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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.
|
Experimental: Intervention Group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale (VAS)
Time Frame: Change from Baseline VAS at 8 weeks
|
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).
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Change from Baseline VAS at 8 weeks
|
Activity Specific Balance Confidence Scale (ABC)
Time Frame: Change from Baseline ABC at 8 weeks
|
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
|
Five Times Sit to Stand Test (5TSST)
Time Frame: Change from Baseline 5TSST at 8 weeks
|
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.
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Change from Baseline 5TSST at 8 weeks
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Cognitive Timed Up and Go Test (CTUG)
Time Frame: Change from Baseline CTUG at 8 weeks
|
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).
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Change from Baseline CTUG at 8 weeks
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Dual-Task Questionnaire (DTQ)
Time Frame: Change from Baseline DTQ at 8 weeks
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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).
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Change from Baseline DTQ at 8 weeks
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Harris Hip Score (HHS)
Time Frame: Change from Baseline HHS at 8 weeks
|
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
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Mini-Mental State Examination (MMSE)
Time Frame: Change from Baseline MMSE at 8 weeks
|
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.
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Change from Baseline MMSE at 8 weeks
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Lower-Extremity Motor Coordination Test (LEMOCOT)
Time Frame: Change from Baseline LEMOCOT at 8 weeks
|
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.
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Change from Baseline LEMOCOT at 8 weeks
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4-Meter Gait Speed (4MGS)
Time Frame: Change from Baseline 4MGS at 8 weeks
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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.
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Change from Baseline 4MGS at 8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Fatih Özden, PhD, Muğla Sıtkı Koçman University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 25, 2023
Primary Completion (Actual)
April 20, 2024
Study Completion (Actual)
April 25, 2024
Study Registration Dates
First Submitted
August 19, 2023
First Submitted That Met QC Criteria
August 19, 2023
First Posted (Actual)
August 24, 2023
Study Record Updates
Last Update Posted (Actual)
May 1, 2024
Last Update Submitted That Met QC Criteria
April 29, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- kalça artroplasti dualtask
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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