Postural Alignment Exercise Mobile App for Cervical and Thoracic Spine Regions

March 3, 2021 updated by: Marmara University

A Mobile App for Postural Alignment Exercises in Cervical and Thoracic Spine Regions: Design, Development, Usability and Randomized Controlled Pilot Study

Postural alignment in the cervical and thoracic regions is affected by various risks such as smartphone use in particular young adults. The small screen of smartphones causes ergonomic risk for posture and musculoskeletal system. Previous studies found that neck, shoulder, and upper back pain associated with the overuse of smartphones. Neck pain often arises from unideal postures. Participants should be informed about these risks and encouraged to exercise to be protective. Digital health apps' use is rising by the day and health apps offer opportunities for both healthcare professionals and users.

Therefore, this study aimed to develop an app including preventive exercise interventions to keep postural alignment in cervical and thoracic spine regions employing an iterative, user-centred design and to test the usability of the app and evaluate its effectiveness with a pilot randomized controlled trial

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İstanbul, Turkey
        • Marmara University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • to be a university student aged 18-25, to be a smartphone user for more than 3 years with more than three hours daily use.

Exclusion Criteria:

  • if they had any chronic health problems (rheumatic, orthopedic, neurological, cardiopulmonary, vestibular system), any trauma in the neck/upper back/upper limb region in the last six months, had a congenital deformity, had received another treatment or having surgery in last one year.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Phase1: Design and development

We conducted focus group meetings to discuss the content, features and design of the app.

The focus group consisted of physiotherapists and young adults. The focus group members discussed the variety of topics in subgroups (login parameters, self-monitoring, exercises content, video or animation types, exercise diary, reminders, encouragement, method, etc).
No Intervention: Phase 2: Testing the app
We tested the prototype version app interface in the 2nd phase. All participants downloaded the prototype app and used the app for one week.
No Intervention: Phase 3: Usability evaluation

We conduct a think-aloud interview and evaluate the quantitative usability in the third phase.

The quantitative usability was assessed by the System Usability Scale (SUS), and the adapted Usability, Satisfaction and Ease to Use (USE) Questionnaire.
Active Comparator: Phase 4: Pilot randomized controlled trial/ The app-based group

The app-based group:

Participants in the intervention group received their smartphone-based- home exercise program.
Other: App-based group

Participants received home exercise programs by a postural alignment exercise mobile app we developed.

The postural alignment app included 3 main emerged themes were recorded as self-assessment, neck/shoulder, and upper back-specific exercise content, and motivational notifications.

Participants can evaluate themselves in the application thanks to the self-assessment, receive motivational notifications during the day, and exercise reminders on the days determined by them. They can apply the exercise program with the formed exercise content videos.

The exercise program consists of combined exercises that postural alignment plus exercises of neck spinal stabilization, stretching, and strengthening of neck/shoulders/upper back regions.

Both group participants were requested to do the exercises from the app/brochure 3 times a week, for 6 weeks.
Experimental: Phase 4: Pilot randomized controlled trial/ The control group

The control group:

Participants in the control group received their home exercise programs as a paper handout.
Other: Control group

Participants received home exercise programs as a paper handout.

The exercise program was the same for app-based and control groups.

Both group participants were requested to do the exercises from the app/brochure 3 times a week, for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of musculoskeletal problems
Time Frame: Baseline
Musculoskeletal problems were assessed by Nordic Musculoskeletal Questionnaire. The Nordic Musculoskeletal Questionnaire queries yes/no for nine body regions so far, in the last 12 months, and in the last 7 days of evaluation, whether ache, pain, or discomfort.
Baseline
VAS
Time Frame: Baseline and at end of the 6 weeks
Neck pain was assessed by Visual Analog Scale (VAS) before and after the 6 weeks exercise program. The participants were instructed to mark a point on a line between zero (no pain) and 10 cm (maximum pain).
Baseline and at end of the 6 weeks
Neck Pain and Disability Scale
Time Frame: Baseline and at end of the 6 weeks
Functional disability associated with neck pain was evaluated by the Neck Pain and Disability Scale (NPAD) questionnaire before and after the 6 weeks exercise program. The Neck Pain and Disability Scale consists of 20 items and each item was scored from 0 to 5, and the total score is the sum of the item scores [possible range 0 (no pain)-100 (maximal pain)].
Baseline and at end of the 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of exercise adherence
Time Frame: At end of the 6 weeks

The app automatically gathers total usage status (count of participated sessions, usage times) when participants login to the app to start an exercise program.

Exercise adherence was measured with a ratio of total participated sessions compared with the target defined.
At end of the 6 weeks
Evaluation of app satisfaction
Time Frame: At end of the 6 weeks
Users were evaluated to rate their satisfaction with the intervention on a 5-point Likert scale after 6 weeks period.
At end of the 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Collaborators

Marmara University, Scientific Research Projects Committee

Investigators

  • Study Director: Eda Tonga, PHD, Marmara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Actual)

September 15, 2018

Study Completion (Actual)

November 1, 2020

Study Registration Dates

First Submitted

February 28, 2021

First Submitted That Met QC Criteria

March 3, 2021

First Posted (Actual)

March 5, 2021

Study Record Updates

Last Update Posted (Actual)

March 5, 2021

Last Update Submitted That Met QC Criteria

March 3, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.2018.069

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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