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

NCT ID: NCT03462264

Last Updated: 2018-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-24

Study Completion Date

2018-12-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Scoliosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised control trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control Group / Group 1

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Group 2

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.

Group Type EXPERIMENTAL

Pre-Formatted Diary

Intervention Type OTHER

The pre-formatted diary will prompt the date, start time, end time and a list exercises that the patient has completed that day that the patient will be requested to fill out.

Group 3

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.

Group Type EXPERIMENTAL

Scoliogold App

Intervention Type DEVICE

The mobile application will include a list of the specific exercises that the patient has to complete on a daily basis. It will have a start/stop button which the patient presses at the beginning and the end of each time that they complete their home exercise programme. This will get logged on to their application which can be accessed by the researcher to monitor home exercise compliance.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Scoliogold App

The mobile application will include a list of the specific exercises that the patient has to complete on a daily basis. It will have a start/stop button which the patient presses at the beginning and the end of each time that they complete their home exercise programme. This will get logged on to their application which can be accessed by the researcher to monitor home exercise compliance.

Intervention Type DEVICE

Pre-Formatted Diary

The pre-formatted diary will prompt the date, start time, end time and a list exercises that the patient has completed that day that the patient will be requested to fill out.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Glynn Analytics

UNKNOWN

Sponsor Role collaborator

Scoliosis SOS Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Georgina Frere

Senior Physiotherapist and Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Georgina CA Frere, BSc

Role: PRINCIPAL_INVESTIGATOR

Scoliosis SOS

Erika Maude

Role: STUDY_DIRECTOR

Scoliosis SOS

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Georgina C Frere, BSc

Role: CONTACT

+442074884428

David AJ Black, BSc

Role: CONTACT

+442074884428

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Scoliosissos

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

tSCS + EksoGT in SCI Patients
NCT05921175 NOT_YET_RECRUITING NA
Treadmill Training for Spinal Cord Injury
NCT00006429 COMPLETED PHASE2