NCT03462264

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 12, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

April 24, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2018

Completed
Last Updated

April 19, 2018

Status Verified

April 1, 2018

Enrollment Period

8 months

First QC Date

February 26, 2018

Last Update Submit

April 17, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • The amount of hours per week exercised on average

    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.

    3 Months

Study Arms (3)

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.

Other: Pre-Formatted Diary

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.

Device: Scoliogold App

Interventions

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.

Group 3

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 2

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Georgina CA Frere, BSc

    Scoliosis SOS

    PRINCIPAL INVESTIGATOR
  • Erika Maude

    Scoliosis SOS

    STUDY DIRECTOR

Central Study Contacts

Georgina C Frere, BSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomised control trial
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Physiotherapist and Consultant

Study Record Dates

First Submitted

February 26, 2018

First Posted

March 12, 2018

Study Start

April 24, 2018

Primary Completion

December 21, 2018

Study Completion

December 21, 2018

Last Updated

April 19, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

All of the data recorded will be anonymised and secured without the plan to share data to other researchers