Knee ArthroplastyNCT06009380
Effectiveness of Dual Task Training in Total Knee Arthroplasty
A study testing Physiotherapy and Rehabilitation in people with Knee Arthroplasty and Rehabilitation, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Knee Arthroplasty, Rehabilitation
- What is being tested?
- Physiotherapy and Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jun 2023to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Have any other orthopedic or neurological problem that may affect treatment and assessments
- Situations that prevent communication
- Lack of cooperation during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Knee Arthroplasty, Rehabilitation
- Being tested
- Physiotherapy and Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy and RehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Other: Physiotherapy and 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. Receives: Other: Physiotherapy and Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change from Baseline VAS at 8 weeks
Knee Society Short Form (KSSF)
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.
Measured: Change from Baseline KSSF 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.
Measured: Change from Baseline MMSE 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).
Measured: Change from Baseline DTQ 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).
Measured: Change from Baseline CTUG at 8 weeks
Lower Extremity Motor Coordination Test (LEMCT)
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).
Measured: Change from Baseline LEMCT 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.
Measured: Change from Baseline 3MBWT at 8 weeks
10-Meter Walk Test (10MWT)
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.
Measured: Change from Baseline 10MWT at 8 weeks
Walking Impact Scale (Walk-12)
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.
Measured: Change from Baseline Walk-12 at 8 weeks
Reaction Time Measurement (RTM)
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.
Measured: Change from Baseline RTM at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start5 Jun 2023
- Primary completion15 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Ozden, Muğla Sıtkı Koçman University
- Investigators
- Fatih Özden, Study director, Muğla Sıtkı Koçman UniversityMustafa Yalçın, MSc, Principal investigator, Bursa Çekirge State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009380
- Sponsor's protocol ID
- TDA Dual Task
- Status last verified
- Apr 2024
- First submitted
- 15 Aug 2023
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Dual Task Training Versus Usual Care in Patients With Total Knee Arthroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06009380
- Acronym / sponsor ID
- TDA Dual Task
- Conditions
- Knee Arthroplasty, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 24 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Physiotherapy and RehabilitationIn 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. |
| Control Group | Active comparator | Other: Physiotherapy and RehabilitationThe control group will receive the usual post-operative care of stretching lower extremity strengthening balance exercises activities of daily living recommendations. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapy and RehabilitationThe 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. | Other | Control Group, Intervention Group |
Primary outcome
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).
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.
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.
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).
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).
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).
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatih Özden study director
Muğla Sıtkı Koçman University
Mustafa Yalçın, MSc principal investigator
Bursa Çekirge State Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy and Rehabilitation in people with Knee Arthroplasty and Rehabilitation, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: Change from Baseline VAS at 8 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.