Effectiveness of Dual Task Training in Total Hip Arthroplasty

Hip Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06009419
• Other study ID #: kalça artroplasti dualtask
• Status: Completed
• Phase: N/A
• Start date: October 25, 2023
• Est. completion date: April 25, 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 25, 2024
• Est. primary completion date: April 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Arthroplasty

Intervention

Other:
• Rehabilitation
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.

Locations

Country	Name	City	State
Turkey	Mugla Sitki Koçman Training and Research Hospital	Mugla	Mentese

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	Five Times Sit to Stand Test (5TSST)	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.	Change from Baseline 5TSST 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	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	Activity Specific Balance Confidence Scale (ABC)	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
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	Harris Hip Score (HHS)	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
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	Lower-Extremity Motor Coordination Test (LEMOCOT)	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.	Change from Baseline LEMOCOT at 8 weeks
Primary	4-Meter Gait Speed (4MGS)	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.	Change from Baseline 4MGS at 8 weeks