Effectiveness of Dual Task Training in Total Knee Arthroplasty

Rehabilitation Clinical Trial

Official title:

Effectiveness of Dual Task Training Versus Usual Care in Patients With Total Knee Arthroplasty: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06009380
• Other study ID #: TDA Dual Task
• Status: Completed
• Phase: N/A
• Start date: June 5, 2023
• Est. completion date: March 30, 2024

Study information

• Verified date: April 2024
• Source: Mugla Sitki Koçman University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 30, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
Turkey	Bursa Çekirge State Hospital	Bursa	Osmangazi

Sponsors (1)

Lead Sponsor	Collaborator
Mugla Sitki Koçman University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.	Change from Baseline KSSF at 8 weeks
Primary	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
Primary	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
Primary	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
Primary	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).	Change from Baseline LEMCT at 8 weeks
Primary	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.	Change from Baseline 3MBWT at 8 weeks
Primary	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.	Change from Baseline 10MWT at 8 weeks
Primary	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.	Change from Baseline Walk-12 at 8 weeks
Primary	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.	Change from Baseline RTM at 8 weeks