- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06009380
Effectiveness of Dual Task Training in Total Knee Arthroplasty
April 29, 2024 updated by: Fatih Ozden, Muğla Sıtkı Koçman University
Effectiveness of Dual Task Training Versus Usual Care in Patients With Total Knee 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 knee arthroplasty surgery.
It is aimed to evaluate pain intensity, disability level, mini mental status, coordination, reaction time 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 Bursa Cekirge State Hospital and who have undergone total knee arthroplasty surgery.
It is aimed to evaluate at least 26 patients for the study.
The first evaluation will be performed 6 weeks post-operatively and the second evaluation will be performed 2 months after the treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
-
-
Osmangazi
-
Bursa, Osmangazi, Turkey
- Bursa Çekirge State Hospital
-
-
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 knee 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 knee arthroplasty
- Presence of revision surgery
- Presence of severe osteoarthritis in the contralateral knee
- Severe acute metabolic neuromuscular and cardiovascular diseases
- Extreme obesity (bmi>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.
|
The control group will receive the usual post-operative care of stretching lower extremity strengthening balance exercises and activities of daily living recommendations.
In addition to the program given to the control group, the dual task program will be given progressively to the study group.
|
Experimental: Intervention Group
In addition to the program given to the control group, the dual task program will be given to the study group progressively as previously stated (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 and activities of daily living recommendations.
In addition to the program given to the control group, the dual task program will be given progressively to the study 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).
|
Change from Baseline VAS at 8 weeks
|
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).
|
Change from Baseline CTUG at 8 weeks
|
Dual-Task Questionnaire (DTQ)
Time Frame: Change from Baseline DTQ at 8 weeks
|
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
|
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.
|
Change from Baseline MMSE at 8 weeks
|
3 Meter Backward Walk Test (3MBWT)
Time Frame: Change from Baseline 3MBWT at 8 weeks
|
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
|
Knee Society Short Form (KSSF)
Time Frame: Change from Baseline KSSF at 8 weeks
|
The scale is a 9-item measure developed to assess total knee arthroplasty patients' satisfaction, expectations, physical activities, and clinical and functional status in the preoperative and postoperative period, reported by both the physician and the patient.
|
Change from Baseline KSSF at 8 weeks
|
Lower Extremity Motor Coordination Test (LEMCT)
Time Frame: Change from Baseline LEMCT at 8 weeks
|
The test requires subjects sitting 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 (13).
|
Change from Baseline LEMCT at 8 weeks
|
10-Meter Walk Test (10MWT)
Time Frame: Change from Baseline 10MWT at 8 weeks
|
A 10 meter long track is marked.
Participants are instructed to "walk comfortably, at your usual pace" until they reach the end of the marked path.
A member of the research team simultaneously measures the walking time with a stopwatch, starting the stopwatch as soon as the participant's lead foot crosses the first mark and stopping it when the participant's lead foot crosses the last mark.
Distance and second data are used to determine walking speed.
|
Change from Baseline 10MWT at 8 weeks
|
Walking Impact Scale (Walk-12)
Time Frame: Change from Baseline Walk-12 at 8 weeks
|
The test consists of 12 items asking about self-perceived walking limitations over the past 2 weeks in activities related to walking, running, climbing stairs, standing, walking distance and effort, need for support indoors and outdoors, elements of gait quality and concentration while walking.
The scale has five response options: 1 = not at all, 2 = a little, 3 = moderately, 4 = somewhat and 5 = extremely.
In clinical practice, the response options for each item are summed to obtain a total score ranging from 12 to 60 points.
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Change from Baseline Walk-12 at 8 weeks
|
Reaction Time Measurement (RTM)
Time Frame: Change from Baseline RTM at 8 weeks
|
A platform with a circle on it is used to measure the stepping reaction.
The participant standing outside the hoop is given a voice command and asked to step the relevant limb into the hoop.
The time between immediately after the command and the first contact phase of stepping into the hoop is taken into account.
The video images are evaluated with the Kinovea program using slow motion technology.
|
Change from Baseline RTM at 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Fatih Özden, Muğla Sıtkı Koçman University
- Principal Investigator: Mustafa Yalçın, MSc, Bursa Çekirge State Hospital
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)
June 5, 2023
Primary Completion (Actual)
March 15, 2024
Study Completion (Actual)
March 30, 2024
Study Registration Dates
First Submitted
August 15, 2023
First Submitted That Met QC Criteria
August 19, 2023
First Posted (Actual)
August 24, 2023
Study Record Updates
Last Update Posted (Actual)
April 30, 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
- TDA Dual Task
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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