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临床试验/CTRI/2025/07/089953
CTRI/2025/07/089953尚未招募不适用

Enhancing home-based rehabilitation for knee stiffness post total knee replacement: A novel approach with wearable motion sensor device

Manipal Academy of Higher Education2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
试验地点
2
主要终点
Range of motion, manual muscle test, visual analogue scale, Knee injury and Osteoarthritis Outcome Score (KOOS), 6 Minute Walk Test, Time up and go

研究概览

简要总结

Pain and a limited range of motion (ROM) among patients undergoing total knee replacement (TKR) surgeries are common complaints during post-operative period. Proper rehabilitation at the community set up is utmost solution for improving joint health to attain the functional level. However, the potentiality for an effective treatment was not continued at home with the use of a particular approach due to various reasons resulting in post-operative joint complications.

When subjective evaluation is not possible in patients’ house, the technology-based monitoring system need to be developed. Some gold standard technology which is portable, wearable, low-cost, accessible to all is the present need of the time by means of sensors attached to knees to measure ROM. The wearable motion sensor device (WMSD) with interactive mobile apps to monitor in-home exercise progress, through wireless telerehabilitation technology and assist in tracking the ROM for knee joint and patient compliance.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
60.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Willing to participate in the study Capable of managing a smartphone and medically stable.
  • Underwent total knee replacement for arthritic changes Discharged from the hospital within 5to7 days.
  • Knee joint presentation (knee flexion lesser than 70 degrees, quadriceps strength lesser than 2plus, extension lag more than 5 degrees).

排除标准

  • Post-op complications such as deep vein thrombosis, infection, or neurovascular disorde.
  • Fixed bony deformity in lower limbs, decreased flexibility of trunk, any musculoskeletal injury or surgery in lower limbs in the last one year.

结局指标

主要结局

Range of motion, manual muscle test, visual analogue scale, Knee injury and Osteoarthritis Outcome Score (KOOS), 6 Minute Walk Test, Time up and go

时间窗: baseine and 8 weeks

次要结局

  • independence of use(patient satisfaction)

研究者

申办方类型
Other [Institution of Eminence, deemed to be university]
责任方
Principal Investigator
主要研究者

Preeti Mohanty

Manipal Institute of Technology

研究点 (2)

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