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临床试验/CTRI/2025/11/096968
CTRI/2025/11/096968招募中不适用

Music Therapy for early rehabilitation of persons with total knee arthroplasty: A Single-Blinded Randomized Controlled Trial

NO1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2025年11月18日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
114
试验地点
1
主要终点
Pain : VAS

研究概览

简要总结

Persons who have undergone total knee arthroplasty (TKA) in the orthopedic department, CMC Vellore, will be assessed for eligibility by the Principal Investigator and included in the study after obtaining written consent. An initial assessment will be performed by the physical therapist (Outcome assessor) who will be blinded to the group allocation. The assessment will include measurement of pain using Visual Analogue Scale (VAS), knee flexion and extension range using a universal goniometer and an accelerometer, muscle power using Modified Oxford scale for manual muscle testing and hand-held dynamometer, knee function will be assessed using Knee injury and Osteoarthritis Outcome Score (KOOS) .Following this, the patients will be randomized using sequentially numbered, opaque, sealed envelope (SNOSE) to two groups. The ambulatory status shall be assessed after 3 days of surgery when patients are able to walk independently by using the 2 minute and 10 meter walk test . The interventional group will receive music therapy in addition to two weeks of conventional physiotherapy (PT). The control group will receive only two weeks of standard PT. During music therapy, patients will listen to music of their choice through earphones in one ear, while the other ear remains unobstructed to hear commands from the physical therapist conducting the conventional PT. Conventional PT will include exercises of the TKA protocol (Appendix I – TKA protocol), which will include isometric exercises, multiangled isometrics, dynamic knee strengthening exercises, and progressive gait training. This will be progressed until suture removal (12th post-op day). At the end of two weeks, the outcomes will be re-assessed by the physical therapist (blinded outcome assessor). The data will be analyzed to find out if the addition of music therapy to a two–week conventional PT helped in reducing pain and improving the joint range of motion and muscle strength when compared to the control group. In addition, ,hospital related anxiety and patient experience will also be analysed.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
50.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients admitted for total knee arthroplasty 2.Age group from 50 to 80 years 3.Both genders.

排除标准

  • Patients undergoing revision knee arthroplasty.
  • Patients presenting with deformities in other joint due ankylosing spondylitis, rheumatoid arthritis.
  • Patients having hearing difficulty.

结局指标

主要结局

Pain : VAS

时间窗: Pain:Day 1 and Day 12 | Knee range: Day 1 and Day 12 | Quadriceps strength:Day 1 and Day 12

Knee range :Universal goniometer and

时间窗: Pain:Day 1 and Day 12 | Knee range: Day 1 and Day 12 | Quadriceps strength:Day 1 and Day 12

accelerometer

时间窗: Pain:Day 1 and Day 12 | Knee range: Day 1 and Day 12 | Quadriceps strength:Day 1 and Day 12

Quadriceps strength:Modified Oxford scale and Hand-

时间窗: Pain:Day 1 and Day 12 | Knee range: Day 1 and Day 12 | Quadriceps strength:Day 1 and Day 12

held dynamometer

时间窗: Pain:Day 1 and Day 12 | Knee range: Day 1 and Day 12 | Quadriceps strength:Day 1 and Day 12

次要结局

  • Knee function :KOOS scale

研究者

发起方
NO
申办方类型
Other [nil]
责任方
Principal Investigator
主要研究者

Ashruto Dey

Christian Medical College Vellore

研究点 (1)

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