跳至主要内容
临床试验/NCT03462264
NCT03462264Unknown不适用

Stage 2: Strategies to Improve Home Exercise Compliance in Patients With Scoliosis: Use of a Mobile Application

Scoliosis SOS Ltd.0 个研究点目标入组 200 人开始时间: 2018年4月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
200
主要终点
The amount of hours per week exercised on average

研究概览

简要总结

This is a second study in a series of 3 studies. The first study assessed exercise compliance of scoliosis patients (adults and children). This study will look at different strategies to improve exercise compliance after a patient has completed an intensive course of treatment at Scoliosis SOS Clinic. It will be a randomised control trial. The control group will receive the regular exercise schedule that is created for the patients at the clinic, there will be two intervention groups, one using the exercise schedule with a diary and one using the exercise schedule with a mobile application. Compliance will be monitored through a questionnaire at their first and second check-up appointments which will take place every 3 months for a patient under the age of 18 and every 6 months for a patient who is 18 years old or over.

详细描述

Patients who have attended an intensive treatment course at Scoliosis SOS Clinic in London will be included in the study. This will include patients finishing an intensive course after the start date of the study or patients who have completed an intensive course up to 11 years ago and are still attending check-up appointments at the clinic. After a patient has completed this intensive course or when they come back for their next check-up appointment after the start date of the study, each patient will be randomised in to one of three groups: 1. Control group, 2. Diary group and 3. Mobile application group.

The patients in the control group will be given their normal exercise schedule without any instruction to record their compliance at the time. The diary group will be given a diary with a specific layout and instructed to note their exercise compliance, including the date, the amount of time and the exercises completed. The mobile application group will be provided with a link to download the application onto their smart phone for free. This group will be instructed to use this application whenever they complete their exercises at home.

The mobile application will include a copy of the patient's exercise schedule (they will also be provided with a hard copy of the exercise schedule), a picture list of all of the exercises present on their exercise schedule as well as a start/stop button which they will be advised to press once they begin their exercise and then again once they have finished exercising. This information will log on their profile, which can be accessed by the researcher.

The patients will be enrolled on to the study on the day that they finish their intensive physiotherapy course or at their next check-up appointment after the study commences. The patient will be given a full informed consent form, detailing every aspect of the study. They will then be asked to sign the form as their way of agreeing to take part in the study. Data will then be collected from each patient on the patient's first and second check-up appointments which usually occur once every three months for children below the age of 18 years old and once every six months for adults that are 18 years old and older. If the patient does not attend a check-up appointment within their recommended time period, they will be contacted via telephone or email to provide the details about their compliance.

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
是

入选标准

  • •all patients who have completed an intensive course of treatment at Scoliosis SOS Clinic from 23.02.2018

排除标准

  • 未提供

研究组 & 干预措施

Control Group / Group 1

No Intervention

This group will receive their personalised exercise schedule after treatment as per routine treatment at the clinic.

Group 2

Experimental

This group will receive their personalised exercise schedule after treatment as per routine treatment at the clinic as well as a pre-formatted diary for them to fill out.

干预措施: Pre-Formatted Diary (Other)

Group 3

Experimental

This group will receive their personalised exercise schedule after treatment as per routine treatment at the clinic as well as a link to download the free ScolioGold App on to their mobile from the clinic.

干预措施: Scoliogold App (Device)

结局指标

主要结局

The amount of hours per week exercised on average

时间窗: 3 Months

Over the past 3 months, on average, how many hours per week do you spend on your scoliosis-specific exercises? is the question that will be asked.

次要结局

未报告次要终点

研究者

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

Georgina Frere

Senior Physiotherapist and Consultant

Scoliosis SOS Ltd.

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