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临床试验/NCT05999864
NCT05999864已完成不适用

Efficacy of Proprioceptive Neuromuscular Facilitation Exercise Programme Versus Usual Care in Patients With Total Knee Arthroplasty: A Randomised Controlled Trial

Muğla Sıtkı Koçman University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年6月8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
50
试验地点
1
主要终点
Figure 8 Walking Test (F8WT)

研究概览

简要总结

This study was planned to investigate the effectiveness of usual care and proprioceptive neuromuscular facilitation exercise program in patients undergoing total knee arthroplasty surgery. It is aimed to evaluate pain intensity, disability level, proprioception, kinesiophobia, balance, range of motion 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 Fethiye State Hospital and who have undergone total knee arthroplasty surgery. The evaluations will be performed in the Orthopedics and Traumatology outpatient clinic of Fethiye State Hospital. It is aimed to evaluate at least 32 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.

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 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

排除标准

  • 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 (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

Figure 8 Walking Test (F8WT)

时间窗: Change from Baseline F8WT at 8 weeks

Participants are instructed to stand at the midpoint between two cones (1.52 m apart) and look at one of the cones. Participants are asked to walk in a circle of 8 around the cones at a comfortable speed and direction of their choice. The stopwatch is stopped while returning to the starting point. The elapsed time and the number of steps taken are recorded.

Knee Joint Proprioception Measurement

时间窗: Change from Baseline Knee Joint Proprioception Measurement at 8 weeks

The inclinometer is placed distal to the tibial tuberosity. In full knee extension, the patient is asked to perform a single leg squat with eyes closed or unable to see the leg being tested. He/she is allowed to support with his/her hands to prevent loss of balance. When the knee flexion angle of 30° is reached, the patient is asked to stop and stay at this point for 5 seconds. Then return to full knee extension. This movement is repeated 3 times. This time, without any stop command, the patient is asked to reach the same 30° knee flexion angle as in the previous exercises. This application is also repeated 3 times. The "absolute angle difference", which is the difference between the targeted angle in each repetition and the angle realized by the patient, is recorded. The arithmetic mean of the 3 repetitions' absolute angle difference is recorded as the result data.

Modified Four Square Step Test (mFSST)

时间窗: Change from Baseline mFSST at 8 weeks

A suitable background is divided into four identical squares with a "+" shaped line using tape. The squares are numbered with numbers between 1-4 in a clockwise direction and this sequence is explained to the participant. The patient steps from the starting point to squares 1,2,3 and 4 in a way that the direction remains the same and without stepping on the lines. The test is terminated when the last foot contact is interrupted at square 4. The time elapsed during the main measurement is recorded with a stopwatch.

Tampa Scale for Kinesiophobia (TSK)

时间窗: Change from Baseline TSK at 8 weeks

The questionnaire is a 17-item scale developed to measure fear of movement/reinjury. The normal score range is between 17 and 68.

Berg Balance Scale (BBS)

时间窗: Change from Baseline BBS at 8 weeks

The 14 items in the scale assess static sitting and standing balance as well as expected balance during activities. Scoring is done on a 5-point scale that takes into account whether the patient can perform the task safely and independently and is usually based on a specific time interval. Normal performances are rated from 0 (unable to perform) to 4 points (normal performance). Scores on individual items are summed for a total score, with a maximum score of 56 points.

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.

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).

Western-Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

时间窗: Change from Baseline WOMAC at 8 weeks

Functionality level in the patient group with knee OA was measured using WOMAC. WOMAC consists of 3 main headings: pain intensity, stiffness and physical function. The individuals included in the study are asked to score each item between 0 (no pain, stiffness, difficulty) and 5 (very severe pain, stiffness, difficulty). The total score ranges from 0 (no disability) to 96 (complete disability).

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 (1)

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