Data

Telerehabilitation and internet-based management of rotator cuff related pain: a pilot and feasibility randomised controlled trial

Monash University

Dataset description

The intervention will be delivered via a tailored online website for participants.
The intervention groups include:
*Group (ii): Detailed education, advice and exercises + “virtual physiotherapist” (performance of exercises is entered into a website and it provides guidance for modification)
*Group (iii): Detailed education, advice and exercises + “virtual physiotherapist” + weekly telerehabilitation session via Zoom with physiotherapist.
We hypothesize the addition of a weekly telerehabilitation session for Group (iii) will improve the personalization and personability of the program while still using an online platform. We anticipate this will improve adherence to the program and result in superior results of primary and secondary outcomes in group (iii) compared to group (i) and group (ii).
The online website has been specifically designed for this trial. It is built to encourage self-navigation throughout the website. The online website was built by an IT expert in conjunction with a physiotherapy shoulder expert.
It will include the education material, which is a document around rotator cuff related pain including anatomy, physiology, contributing factors, treatment and advice including activity modification and recommended care. This is provided in both written and video format.
It also includes the exercise intervention, which is provided in both written and video exercises. There will be two exercises: shoulder elevation in standing; and shoulder external rotation in side-lying. Three sets of 15 repetitions of each exercise will be performed. The exercise will be individualised based on pain (pain should be minimal during the exercise, i.e. less than 5/10 on a 10-point numerical rating scale), and capacity (they should feel they are not able to perform more than 2 additional repetitions at the end of each set of 15). Participants are encouraged to modify the exercises (either make easier or more difficult) as per their self-perceived levels of pain. If they find the exercise too easy, they are prompted to increase the exercise intensity by adding external load in increments of 1kg. Each day they should ensure that they can perform the exercise with acceptable pain (<5/10). If this is not the case they will be advised to regress, i.e. reduce the weight, or revert to an isometric holding exercise (holding a weight statically). If there is still unacceptable pain (5/10 or above) they will be advised to rest for that day.
Participants are required to complete their exercises daily, unless their pain symptoms guide them to rest for the day and try again the following day. Participants in group (ii) and group (iii) are expected to enter what exercises they completed (and any modifications) into a daily recording page within the website. This will track adherence to the program and allow the monitoring of progression of exercise and participation throughout the trial.
All participants will be required to complete an online survey at baseline, at six weeks and at twelve weeks at the conclusion of the study. Participants will be required to complete an initial baseline Zoom session, and participants in group three will be required to complete a weekly telerehabilitation session. This weekly telerehabilitation session will be completed via Zoom, an online videoconference platform. It will be set up at an agreed upon time between the physiotherapist and the participant. The aim of the session is to assess exercise technique, suggest progressions if indicated and answer any participant questions. It is expected to take between 10-30 minutes per week.
Participants will be provided with education at baseline and required to complete a questionnaire regarding this education to measure knowledge improvement. The education intervention has been developed with input from multidisciplinary expert shoulder clinicians.
Click to explore relationships graph

Source Study

Trial acronym

Not available

Trial ID

ACTRN12620000088943

Purpose

Prevention

Phase

Not Applicable

Funding

Government body,Australian National Health and Medical Research Council

Scientific enquiries

Dr Thach Tran

Brief Summary

Mental health problems are more prevalent among adolescents in low- and lower-middle income countries (LALMIC), where most of the world’s young people live, than in high-income countries. As yet, there is little recognition of mental health, and few mental health programs or services exist for adolescents in these settings. We have demonstrated that in Vietnam, one in seven young people attending secondary school had experienced suicidal thoughts or plans in the previous year, over a third (34%) ....
Read more

Key Inclusion Criteria

Grade 10 student Studying in a selected class

Key Exclusion Criteria

Students whose parents do not give permission for them to participate. Students who do not wish to participate.

Can healthy volunteers participate?

Yes

 

Population

Sample Size    1084

Min. age    14 Years

Max. age    17 Years

Sex    Both males and females

Condition category    Mental health

Condition code    Mental Health

Intervention

Intervention code Behaviour , Prevention

Intervention name - Happy House The Resourceful Adolescent Program for adolescents (RAP-A) is a school-based program designed to promote factors that protect against adolescent depression and other mental health problems. It is a strengths-based program, focussed on developing strengths rather than on the pathology. The intervention for this trial is Happy House, the culturally-adapted RAP-A for adolescents in Vietnam. Happy House will be delivered through six workshop-style sessions, with a foc ....
Read more

Comparison

Control group Active

Participants in the control group will only receive the usual school curriculum.

Outcomes

Outcome: Depression, assessed using the Centre for Epidemiologic Studies Depression Scale Revised (CESD-R)
Timepoint: Six months post-intervention

Study Protocol: Not Available
Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?

yes

What data in particular will be shared?

All individual participant data collected during the trial will be shared after de-identification

When will data be available?

Data will be available from 31/12/2021, with no determined end date

Available to whom?

Anyone who wishes to access the data will be able to

Available for what types of analyses?

The data will be available for analyses of any purpose

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au