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临床试验/NCT03738384
NCT03738384已完成不适用

Knee Connect: Physiotherapy Exercise Performance With Visual Feedback After Total Knee Arthroplasty - Pilot Study

Sunnybrook Health Sciences Centre1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年3月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Knee angle (degrees)

研究概览

简要总结

The main objective of this pilot study is to determine if using a portable, accelerometer based, visual feedback system improves exercise quality. The secondary objective of this study is to investigate the effect of motivational targets by testing the effects of increasing Range of Motion (ROM) targets. The results from this study will be used to improve the visual feedback system of the Knee Connect system and serve as starting point for a larger clinical study.

详细描述

The research team will recruit 10 post-op total knee replacement patients who are enrolled in the Knee Class at Sunnybrook Holland Orthopaedic and Arthritic Centre to perform five exercises over two sessions. Each patient will complete five tasks.

  1. Quarter squats
  2. Standing hip flexion
  3. Standing knee flexion
  4. Sitting knee extension
  5. Sitting knee flexion

The first three exercises will be performed with and without visual feedback. During standing hip flexion, standing knee flexion and quarter squat exercises, patients will first perform a set of each exercise following an instruction brochure. Patients will then repeat these exercises with the Knee Connect visual feedback system. The KneeConnect will be worn during the entire session, and will record the patient's knee angle and velocity regardless of visual feedback condition.

For the next two exercises, sitting knee extension and sitting knee flexion, patients will perform the first set of exercises (3 repetitions) with visual feedback of their leg position in space but without seeing an end target. The Knee Connect will measure the knee angle during these tests. For the subsequent set, the Knee Connect system will present a visual target for the patient to achieve. This target will be 5 degrees above the patient's maximum terminal knee angle recorded without motivational targets. A third set will be completed with the knee angle target set 10 degrees above the patient's maximum. A caveat to the target modification for seated knee extensions is that target changes to hyperextension, will result in a full extension target.

After each participant has completed the exercises with the KneeConnect system they will be asked to complete a short survey. The survey has been designed to assess the KneeConnect's usefulness and how much participants liked using the system.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Be enrolled in the "Knee Class" postoperative physiotherapy
  • •Be able to provide informed consent
  • •3-6 weeks post-operative from primary total knee replacement surgery

排除标准

  • •Revision total knee arthroplasty
  • •Neuromuscular disorder
  • •Knee Stiffness (knee flexion of <90 degrees during previous Knee Class session)
  • •Hip Stiffness (hip flexion of <90 degrees)

研究组 & 干预措施

TKR Patients

Experimental

Any patient 3-6 weeks post-op from a TKR

干预措施: Knee Connect + Visual Feedback System (Device)

结局指标

主要结局

Knee angle (degrees)

时间窗: One set of measurements 3-6 weeks post TKR

The difference in measured knee angle with and without visual feedback.

Knee velocity (degrees/s)

时间窗: One set of measurements 3-6 weeks post TKR

The difference in measured knee velocity with and without visual feedback.

次要结局

  • Peak knee flexion and extension angle (degrees)(One set of measurements 3-6 weeks post TKR)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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