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NCT Number: NCT05704023

Effects of a Mobile App on Adherence to Daily Exercise and Recovery After Whiplash Injury

This study investigates the effect of daily mobile app reminders to exercise in conjunction with standard physical therapy on adherence to exercise and recovery after whiplash injury of the neck. Participants will be divided into two groups, the experimental (Arm A) and control group (Arm B). Both groups will complete a standard physical therapy program under the supervision of a physiotherapist. Both groups will get illustrated home exercise programs and will be advised to continue exercising at home. In addition, the experimental group will receive one daily push notification via a mobile app to perform a daily exercise at home.

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Key information

Conditions

Whiplash Injury of Cervical Spine Neck Injuries Whiplash Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Split

Split, 21000, Croatia

About this study

Whiplash injury of the neck is the most common injury resulting from a traffic accident. Although most people recover completely, 30 to 50% of them develop chronic neck pain and disability. Also, long sick leaves and lower productivity at work create a burden on the healthcare system.

Conservative treatment includes exercise, physical therapy modalities such as transcutaneous electric nerve stimulation (TENS), and ultrasound therapy. Although conservative treatment is recommended, the evidence of its efficacy remains unclear. Education after the injury can be beneficial in lowering anxiety and pain.

Many studies are investigating the usefulness of mobile apps in various medical conditions. In rehabilitation medicine, apps are used to increase knowledge about different conditions, as a measurement tool, and as an intervention to increase adherence to the prescribed therapy.

After the enrollment in the study, participants will complete the two-part physical therapy program (2x10 sessions, 5times/day, 3-week break in between) under the supervision of a physiotherapist at the outpatient clinic. After completing the program, the participants will get a home exercise program, group A via mobile app, and group B via papers, and will be encouraged to continue exercising at home. Also, group A will download a mobile app, "WIapp," that was developed for this purpose and will receive one daily push notification as a reminder to perform a daily exercise at home.

The investigators hypothesize that daily reminding to exercise via mobile app can increase adherence to prescribed therapy and overall increase recovery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients who sustained whiplash injury of the neck in a car accident as drivers or co-drivers
  • diagnosed with a whiplash injury of the neck by physical and rehabilitation medicine specialist within 3 months
  • Neck Disability Index (NDI) score higher than 5 (10%)
  • possession of and ability to use a smartphone and a mobile app
  • age ≥ 18 years
  • signed written informed consent

Exclusion criteria

  • bone fracture sustained in the accident
  • spinal cord injury
  • accident in any other type of vehicle other than car
  • treatment of malignant disease in the last 5 years
  • expected non-compliance (not possible to use a smartphone because of severe mental or physical impairment)

Treatment and study plan

Reminder to exercise

Behavioral

Exercise support: Daily, at 7 p.m. patients will get a notification with a reminder to exercise. The app includes photographs of exercises, with instructions, that patients can look at and read if they forget which exercises they need to do and how.

Primary outcomes

  1. Change in Neck Disability Index from baseline to 6 months after the injury

    Time frame: baseline, 6 months after the injury

    Physical functioning - where values from 0-8% are regarded as no disability, 10-28% mild disability, 30-48% as moderate disability, 50-68% severe disability, and 70-100% complete disability)

Secondary outcomes

  1. Questionnaire assessment of adherence to exercise

    Time frame: 6 months after the injury

    Adherence to exercise - a 4-point Likert scale regarding weekly exercise completion (classified as: ≥5 sessions/week, 2-4 sessions/week, occasional or no sessions)

  2. Questionnaire assessment of perceived recovery

    Time frame: 6-months after the injury

    Perceived recovery - a 3-point Likert scale on perceived recovery (where 1 indicates non-recovery and 3 indicates full recovery)

  3. Change in Visual Analog Scale (VAS) Pain Score from baseline to 6 months after the injury

    Time frame: baseline, 6 months after the injury

    Pain intensity - ranging from 0 = no pain, to 10 = maximum pain

  4. Pain catastrophizing scale

    Time frame: baseline

    Psychological functioning - (score range from 0-50, a score of 30 or more represents clinically significant level of catastropihizing)

  5. Short Form Health Survey 12

    Time frame: baseline

    Quality of life - With this questionnaire, it is possible to quantitatively compare physical, psychological, and social consequences caused by impaired health. The score for each question is transformed into standard values and placed on the scale from 0 to 100 (the higher the score the better health) and thus get two major dimensions of health: physical (Physical Common Score-PCS)and mental health (Mental Common Score-MCS).

  6. Questionnaire assessment of social functioning

    Time frame: baseline

    A 5-point Likert scale regarding interference of physical or emotional problems with social function (where 1 indicates constant interference and 5 indicates never)

  7. Questionnaire assessment work

    Time frame: baseline, 6 months after the injury

    The assessment of work with a work status information, a work-time loss and 6-point Likert scale (where 1 indicates normal work capability and 6 indicates no working capability9

  8. Pain catastrophizing scale

    Time frame: 6 months after the injury

    Psychological functioning - (score range from 0-50, a score of 30 or more represents clinically significant level of catastropihizing)

  9. Short Form Health Survey 12

    Time frame: 6 months after the injury

    Quality of life - With this questionnaire, it is possible to quantitatively compare physical, psychological, and social consequences caused by impaired health. The score for each question is transformed into standard values and placed on the scale from 0 to 100 (the higher the score the better health) and thus get two major dimensions of health: physical (Physical Common Score-PCS)and mental health (Mental Common Score-MCS).

  10. Questionnaire assessment of social functioning

    Time frame: 6 months after the injury

    A 5-point Likert scale regarding interference of physical or emotional problems with social function (where 1 indicates constant interference and 5 indicates never)

Sponsors and collaborators

Lead sponsor

Blaz Barun

Other

Registry information

Official study title

Effects of a Mobile App on Adherence to Daily Exercise and Recovery After Whiplash Injury - a Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 30, 2023
Registry last updated
Sep 23, 2024

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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