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Completed

NCT Number: NCT04784793

Postural Alignment Exercise Mobile App for Cervical and Thoracic Spine Regions

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

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Key information

Conditions

Development and Design of Mobile App Back Pain Cervical and Thoracic Spine Exercise Adherence Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Preventive Physiotherapy Signs and Symptoms

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

App-based group

Other

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.

Control Group

Other

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.

Primary outcomes

  1. 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.

  2. 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).

  3. 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)].

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2020
First posted
Mar 5, 2021
Registry last updated
Mar 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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