- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05704023
Effects of a Mobile App on Adherence to Daily Exercise and Recovery After Whiplash Injury
Effects of a Mobile App on Adherence to Daily Exercise and Recovery After Whiplash Injury - a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: University Hospital Split
- Phone Number: +38521556111
- Email: office@kbsplit.hr
Study Locations
-
-
-
Split, Croatia, 21000
- Recruiting
- University Hospital Split
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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 |
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
baseline, 6 months after the injury
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
6 months after the injury
|
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)
|
6-months after the injury
|
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
|
baseline, 6 months after the injury
|
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)
|
baseline
|
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).
|
baseline
|
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)
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baseline
|
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
|
baseline, 6 months after the injury
|
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)
|
6 months after the injury
|
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).
|
6 months after the injury
|
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)
|
6 months after the injury
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Aljinović, University Hospital Split
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4090457
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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