跳至主要内容
临床试验/NCT06009419
NCT06009419已完成不适用

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

Muğla Sıtkı Koçman University2 个研究点 分布在 2 个国家目标入组 28 人开始时间: 2023年10月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
28
试验地点
2
主要终点
Dual-Task Questionnaire (DTQ)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Dual-Task Questionnaire (DTQ)

时间窗: 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).

4-Meter Gait Speed (4MGS)

时间窗: Change from Baseline 4MGS at 8 weeks

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.

Visual Analog Scale (VAS)

时间窗: 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).

Lower-Extremity Motor Coordination Test (LEMOCOT)

时间窗: Change from Baseline LEMOCOT at 8 weeks

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.

Activity Specific Balance Confidence Scale (ABC)

时间窗: Change from Baseline ABC at 8 weeks

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.

Harris Hip Score (HHS)

时间窗: Change from Baseline HHS at 8 weeks

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).

Five Times Sit to Stand Test (5TSST)

时间窗: Change from Baseline 5TSST at 8 weeks

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.

Cognitive Timed Up and Go Test (CTUG)

时间窗: 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).

Mini-Mental State Examination (MMSE)

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Muğla Sıtkı Koçman University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatih Ozden

Assistant Professor

Muğla Sıtkı Koçman University

研究点 (2)

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