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临床试验/NCT03734380
NCT03734380Unknown不适用

Lower Knee Joint Loading by Real-time Biofeedback Stair Walking Rehabilitation for Patients With Medial Compartment Knee Osteoarthritis

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
57
试验地点
1
主要终点
Change in knee adduction moment (KAM)

研究概览

简要总结

This study will establish a machine-learning algorithm to predict KAM using IMU sensors during stair ascent and descent; and then conduct a three-arm randomized controlled trial to compare the biomechanical and clinical difference between patients receiving a course of conventional laboratory-based stair retraining, sensor-based stair retraining, and walking exercise control (i.e., walking exercise without gait retraining). The investigators hypothesise that the wearable IMUs will accurately predict KAM during stair negotiation using machine-learning algorithm, with at least 80% measurement agreement with conventional calculation of KAM. The investigators also hypothesise that patients randomized to the laboratory-based and sensor-based stair retraining conditions would evidence similar (i.e., weak and non-significant differences) reduction in KAM (primary outcome) and an improvement of symptoms (secondary outcomes), but that these subjects would evidence larger reductions in KAM than subjects assigned to the walking exercise control condition.

详细描述

Conventionally, gait retraining is necessarily implemented in a laboratory environment because evaluation of biomechanical markers, such as KAM, requires sophisticated motion capturing system and force plates. With advancement of wearable sensor technology, it is possible to measure gait biomechanics and provide real time biofeedback for gait retraining using inertial measurement unit (IMU), which is a lightweight and portable wireless device. In an ongoing government funded project, the investigators have developed IMU embedded footwear that measures KAM during level ground walking. The investigators have compared Least Absolute Shrinkage and Selection Operator (LASSO) regression and Random Forest in the prediction of KAM from IMU recordings. The investigators found that Random Forest could provide much higher KAM prediction accuracy than LASSO regression. The agreement between conventional laboratory-based and sensor-based measurement of KAM was approximately 90%. Based on investigators' previous research work, it is meaningful to extend the newly developed technology for KAM measurement during stair ascent and descent without the use of laboratory equipment. With the wearable sensors connected to the smartphones, gait retraining outside laboratory environment will become feasible but the effects of gait retraining using wearable sensors have not been directly verified.

Given these considerations, this project has two primary aims. The investigators will: (1) first establish a machine-learning algorithm to predict KAM using IMU sensors during stair ascent and descent; and then (2) conduct a three-arm randomized controlled trial to compare the biomechanical and clinical difference between patients receiving a course of conventional laboratory-based stair retraining, sensor-based stair retraining, and walking exercise control (i.e., walking exercise without gait retraining).

Primary hypothesis

Hypothesis 1: The wearable IMUs will accurately predict KAM during stair negotiation using machine-learning algorithm, with at least 80% measurement agreement with conventional calculation of KAM.

Hypothesis 2: Patients randomized to the laboratory-based and sensor-based stair retraining conditions would evidence similar (i.e., weak and non-significant differences) reduction in KAM (primary outcome) and an improvement of symptoms (secondary outcomes), but that these subjects would evidence larger reductions in KAM than subjects assigned to the walking exercise control condition.

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
Single (Outcomes Assessor)

入排标准

年龄范围
45 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 45-80 years of age;
  • patients with early medial compartment knee OA (Kellgren & Lawrence grade = 1 or 2);
  • self-reported knee pain at least once per week for the proceeding eight weeks;
  • patients should be able to walk unaided for at least 60 minutes.

排除标准

  • have a body mass index >35;
  • have a known learning disability;
  • use a shoe insert or knee brace;
  • have received corticosteroid injection within the previous eight weeks;
  • have absolute contraindications for vigorous physical activities according to the American College of Sports Medicine;
  • in order to avoid floor effect of training, all subjects will undergo an initial screening and only those with KAM greater than 0.3 Nm/kg during level ground walking will be invited into the retraining study.

结局指标

主要结局

Change in knee adduction moment (KAM)

时间窗: baseline and 7 weeks

The surrogate marker of the medial compartment knee joint loading (i.e. KAM) will be measured by a 10-camera motion capture system (Vicon, Oxford Metrics Group, Oxford, UK) at 100 Hz and an instrumented staircase equipped with two force plates (Bertec, Columbus, OH, USA) at 1000Hz during stair ascent and descent at baseline assessment and after 6-week stair retraining.

次要结局

  • Change in Chinese Knee Injury and Osteoarthritis Outcome Score (KOOS)(baseline and 7 weeks)
  • Chnage in validated visual analogue scale (VAS)(basleline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks and 7 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Roy Tsz-hei CHEUNG

Associate Professor

The Hong Kong Polytechnic University

研究点 (1)

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