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

Sponsor
Blaz Barun (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05704023
Collaborator
(none)
60
1
2
11
5.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Reminder to exercise
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Care Provider)
Primary Purpose:
Treatment
Official Title:
Effects of a Mobile App on Adherence to Daily Exercise and Recovery After Whiplash Injury - a Randomized Controlled Trial
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mobile app (WIapp) group

Standard physical therapy program: 2x10 sessions, 5 times a week, 3-week break in between; Mobile app with instructions on exercise at home and daily reminder to exercixse

Behavioral: Reminder to exercise
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.

No Intervention: Control group

Standard physical therapy program: 2x10 sessions, 5 times a week, 3-week break in between, written instructions on exercises at home

Outcome Measures

Primary Outcome Measures

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

  1. Questionnaire assessment of adherence to exercise [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 [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 [baseline, 6 months after the injury]

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

  4. Pain catastrophizing scale [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 [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 [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 [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 [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 [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 [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Split Split Croatia 21000

Sponsors and Collaborators

  • Blaz Barun

Investigators

  • Study Director: Aljinović, University Hospital Split

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Blaz Barun, Principal Investigator, University of Split, School of Medicine
ClinicalTrials.gov Identifier:
NCT05704023
Other Study ID Numbers:
  • 4090457
First Posted:
Jan 30, 2023
Last Update Posted:
Jan 30, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Blaz Barun, Principal Investigator, University of Split, School of Medicine
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 30, 2023