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临床试验/NCT05076539
NCT05076539Unknown不适用

A Quantitative Assessment of Early Mobility in Total Knee Replacement Patients Using Smart Activity Tracker

Singapore General Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年6月11日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Oxford Knee

研究概览

简要总结

This study aims to evaluate the patients' mobility and quality of life prior to their total knee replacement surgery and their progress pre-operatively and 6 months post-operatively using the smart activity tracker. We hypothesize that mobility limitation presents a strong correlation with reduced quality of life.

详细描述

The present study is to determine the effect of TKA based on their mobility and QOL pre and post surgery. The GPS and accelerometry-based tracker will be able to provide quantitative-based outcomes to indicate the physical activity of patients after TKR remains at or above pre-surgical levels.

A total of 50 participants are to be enrolled in this cross-sectional study. Patients who will be required to undergo unilateral total knee replacement will be recruited when fulfilling the respective inclusion and exclusion criteria. The patients will undergo the standard consultations and rehabilitation pre - and post operative care, no changes to the treatment itself will be made. After recruitment and counseling by the surgeon for TKR, the patients will have pre-operative baseline clinical scores taken prior to surgery. They will subsequently have their TKR surgery. Post-operatively, they will be followed up prospectively at the clinics as well as Orthopaedics Diagnostic Centre. Their outcome will be evaluated using validated scoring system, Oxford Knee Score, SF-36, Knee Society Clinical Rating System, satisfaction questionnaire, as well as be provided with a GPS-activity tracker.

50 patients will be issued a Garmin GPS-activity tracker where they will be required to wear for 24 hours for 1 week, prior to each timepoint (pre-operatively and 6 months post surgery). The de-identified raw data gathered from the Garmin tracker will be collected by Curtin University for their analysis.

The patients will undergo the standard consultations and rehabilitation pre - and postoperative care, no changes to the treatment itself will be made.

Standard consultations/review by orthopaedic specialist

研究设计

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

入排标准

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

入选标准

  • Patients who are referred by the Orthopaedic surgeon and are diagnosed with Knee Osteoarthritis, and consented to unilateral total knee replacement.
  • Able to ambulate with or without walking aid.
  • Ability to provide informed consent.

排除标准

  • Patients who have severe bilateral Knee Osteoarthritis, affecting their ability to walk and only one will be operated on.
  • Patients with pre-existing cognitive issues, such as dementia.
  • Patients planning for another surgery within 6 months after their TKR.
  • Patients with existing co-morbidities that limit their walking ability, such as severe respiratory distress syndromes.

结局指标

主要结局

Oxford Knee

时间窗: 6 months post surgery

Using the Oxford Knee questionnaire to get the oxford knee score

Discharge Destination

时间窗: up to 6 months post surgery

Where the patient will be going to after discharge from SGH

SF 36 Health survey

时间窗: 6 months post surgery

SF36 questionnaires to get SF-36 scores

Type of walking aids used

时间窗: up to 6 months post surgery

The type of walking aids required, namely, walking frame, broad- and narrow-based quadstick, or walking stick (in descending order of base of support provided)

Data Collected from Garmin GPS-activity tracker

时间窗: 6 months post surgery for 1 week

1. Latitude and longitudinal location coordinates to determine an individual's activity space 2. Distance travelled 3. Walking speed 4. Heart rate 5. Calories burned 6. Energy expenditure 7. Steps count 8. Physical activity

Knee Society Clinical Rating system

时间窗: 6 months post surgery

Measuring knee range of motion, knee extension lag, knee alignment in standing using the knee society clinical rating system (KSS Scores)

Length of stay

时间窗: up to 6 months post surgery

the number of nights spend in the hospital from the day of surgery

Knee range-of-motion

时间窗: up to 6 months post surgery

measure knee ROM

Ability to perform a straight leg raise

时间窗: up to 6 months post surgery

If patient is able to lift their leg independently. Lag is measured by a goniometer measured by a goniometer

Expectation met for surgery

时间窗: 6 months post surgery

Patient satisfaction form

Overall result of surgery

时间窗: 6 months post surgery

Subject's summary and outcomes form; data collected from Orthopaedic diagnostis center (ODC)

Premorbid history

时间窗: up to 6 months post surgery

Patients reported ambulation status before surgery, including the use of walking aids and assistance level required

Early ambulation rate

时间窗: up to 6 months post surgery

Percentage of patients who start walking postoperative day (POD) 1

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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