跳至主要内容
临床试验/NCT04289025
NCT04289025已完成不适用

Digital Health: Modelling and Artificial Intelligence Using Sensor Data to Personalise REHABilitation Following Joint Replacement

Norfolk and Norwich University Hospitals NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2020年9月23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
46
试验地点
1
主要终点
Subjective change in gait

研究概览

简要总结

This study aims to determine a volunteer's gait objectively after surgery, when signed off from the consultant and physiotherapist. This will identify any gait deficiencies using simple traffic light coding, using GaitSmart, a CE Marked Class 1M Medical Device. Volunteers chosen for the intervention programme, a set of exercises to improve gait deficiencies identified in the report. All the exercises will be standard one already used within the NHS. The objectives are to compare the outcomes from the intervention group with the Standard of Care group, in terms of gait and PROMS and from this determine the clinical and economic benefits of the intervention.

详细描述

This study aims to determine a volunteer's gait objectively after surgery, when signed off from the consultant and physiotherapist. This will identify any gait deficiencies using simple traffic light coding, using GaitSmart, a CE Marked Class 1M Medical Device. All volunteers in the intervention group will be provided with a copy of their report. Protocol for SoC group SoC volunteers receive a GaitSmart test at their first appointment but are not given their report. Questionnaires to record Volunteer reported outcome measures (PROMS) include: Oxford hip score (OHS) or Oxford knee score (OKS) plus the Euroqol questionnaire (EQ5D-5D) are completed. SoC volunteers return at week 15 for a second test but are not given their report. Questionnaires to record Volunteer reported outcome measures (PROMS) include: Oxford hip score (OHS) or Oxford knee score (OKS) plus the Euroqol questionnaire (EQ5D-5D) are completed. Protocol for GaitSmart intervention group GaitSmart intervention group have the procedure explained to them at the first appointment. All exercises have the volunteer standing or sitting and are chosen from exercises already provided by the NHS. Each volunteer will get a subset of these. The nurse will ensure volunteers can perform the exercises before leaving the session. GaitSmart test performed at weeks 6, 9, 12 and 15. The report is provided plus six personalised exercises. The nurse will check they are able to perform the tests at each visit. Those not suitable will be struck off the list. Questionnaires to record Volunteer reported outcome measures (PROMS) will be completed at weeks 6 and 15.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •The subject must provide written informed consent.
  • •Subject is scheduled for primary Total Knee replacement / Total Hip replacement within the next 30 days.
  • •Subject is considered skeletally mature.
  • •Subject is willing, able, and plans to perform the activities associated with the study.
  • •Unilateral or bilateral hip or knee replacement volunteers free of moderate to severe pain in the contralateral limb.
  • •Signed off at 6 weeks by physiotherapist.

排除标准

  • •Will not be a resident living within the catchment area for Norfolk & Norwich University hospital for at least 6 months post-surgery.
  • •Undertaking the surgery as a private patient.
  • •Patients who, in the opinion of the clinical staff, do not have capacity to consent.
  • •Patients who are pregnant.
  • •Unable to understand written and spoken English.
  • •Patient who is currently enrolled in another interventional trial involving surgery, exercise or rehabilitation.
  • •Any neurological condition that affects movement.

研究组 & 干预措施

No Intervention

No Intervention

This group of patients will receive no intervention.

Exercise

Active Comparator

Personalised exercise programme is provided to the exercise group.

干预措施: Exercise (Other)

结局指标

主要结局

Subjective change in gait

时间窗: 15 weeks post op

Change in a patient's Oxford hip or knee score

Objective change in gait kinematics

时间窗: 15 weeks post op

Change in a patient's gait measured objectively using Gaitsmart

Quality of life changes

时间窗: 15 weeks post op

Change in a patient's Quality of Life score (EQ5D)

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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