Effectiveness of Dual Task Training in Total Knee Arthroplasty

• ClinicalTrials.gov Identifier: NCT06009380
• Recruitment Status: Completed
• First Posted: August 24, 2023
• Last Update Posted: April 30, 2024
• Sponsor: Muğla Sıtkı Koçman University
• Information provided by (Responsible Party): Fatih Ozden, Muğla Sıtkı Koçman University

Tracking Information

• First Submitted Date: August 15, 2023
• First Posted Date: August 24, 2023
• Last Update Posted Date: April 30, 2024
• Actual Study Start Date: June 5, 2023
• Actual Primary Completion Date: March 15, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 19, 2023)

• 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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effectiveness of Dual Task Training in Total Knee Arthroplasty
• Official Title: Effectiveness of Dual Task Training Versus Usual Care in Patients With Total Knee Arthroplasty: A Randomized Controlled Trial
• Brief 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. 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Knee Arthroplasty
• Rehabilitation

Intervention

Other: Physiotherapy and Rehabilitation

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 Arms

• 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.
  Intervention: Other: Physiotherapy and Rehabilitation
• 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.
  Intervention: Other: Physiotherapy and Rehabilitation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 29, 2024): 28
• Original Estimated Enrollment (submitted: August 19, 2023): 26
• Actual Study Completion Date: March 30, 2024
• Actual Primary Completion Date: March 15, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 60 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT06009380
• Other Study ID Numbers: TDA Dual Task
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Fatih Ozden, Muğla Sıtkı Koçman University
• Original Responsible Party: Same as current
• Current Study Sponsor: Muğla Sıtkı Koçman University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Fatih Özden; Muğla Sıtkı Koçman University
• Principal Investigator: Mustafa Yalçın, MSc; Bursa Çekirge State Hospital

• PRS Account: Muğla Sıtkı Koçman University
• Verification Date: April 2024