Whiplash Injury of Cervical SpineNCT05704023
Effects of a Mobile App on Adherence to Daily Exercise and Recovery After Whiplash Injury
A study testing Reminder to exercise in people with Whiplash Injury of Cervical Spine, run by Blaz Barun at 1 site in Croatia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Whiplash Injury of Cervical Spine
- What is being tested?
- Reminder to exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteCroatia
- Study dates
- 20 Jan 2023to 13 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Mobile App on Adherence to Daily Exercise and Recovery After Whiplash Injury - a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Whiplash Injury of Cervical Spine
- Being tested
- Reminder to exercise
- Keywords
- Whiplash, Adherence, Recovery, Mobile app
- Medical subject headings
- Whiplash Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reminder to exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mobile app (WIapp) group | Experimental | 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 Receives: Behavioral: Reminder to exercise |
| Control group | No intervention | Standard physical therapy program: 2x10 sessions, 5 times a week, 3-week break in between, written instructions on exercises at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Neck Disability Index from baseline to 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)
Measured: baseline, 6 months after the injury
Secondary outcomes (10)
Questionnaire assessment of adherence to exercise
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)
Measured: 6 months after the injury
Questionnaire assessment of perceived recovery
Perceived recovery - a 3-point Likert scale on perceived recovery (where 1 indicates non-recovery and 3 indicates full recovery)
Measured: 6-months after the injury
Change in Visual Analog Scale (VAS) Pain Score from baseline to 6 months after the injury
Pain intensity - ranging from 0 = no pain, to 10 = maximum pain
Measured: baseline, 6 months after the injury
Pain catastrophizing scale
Psychological functioning - (score range from 0-50, a score of 30 or more represents clinically significant level of catastropihizing)
Measured: baseline
Short Form Health Survey 12
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).
Measured: baseline
Questionnaire assessment of social functioning
A 5-point Likert scale regarding interference of physical or emotional problems with social function (where 1 indicates constant interference and 5 indicates never)
Measured: baseline
Questionnaire assessment work
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
Measured: baseline, 6 months after the injury
Pain catastrophizing scale
Psychological functioning - (score range from 0-50, a score of 30 or more represents clinically significant level of catastropihizing)
Measured: 6 months after the injury
Short Form Health Survey 12
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).
Measured: 6 months after the injury
Questionnaire assessment of social functioning
A 5-point Likert scale regarding interference of physical or emotional problems with social function (where 1 indicates constant interference and 5 indicates never)
Measured: 6 months after the injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start20 Jan 2023
- Primary completion13 Aug 2024
- Study completion13 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Whiplash Injury of Cervical SpineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blaz Barun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Blaz Barun, University of Split, School of Medicine
- Investigators
- Aljinović, Study director, University Hospital of Split
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704023
- Sponsor's protocol ID
- 4090457
- Status last verified
- Sep 2024
- First submitted
- 19 Jan 2023
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Barun B, Divic Z, Martinovic Kaliterna D, Poljicanin A, Benzon B, Aljinovic J. Mobile App Intervention Increases Adherence to Home Exercise Program After Whiplash Injury-A Randomized Controlled Trial (RCT). Diagnostics (Basel). 2024 Dec 4;14(23):2729. doi: 10.3390/diagnostics14232729.
PubMed 39682637
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Mobile App on Adherence to Daily Exercise and Recovery After Whiplash Injury - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05704023
- Acronym / sponsor ID
- 4090457
- Conditions
- Whiplash Injury of Cervical Spine
- Keywords
- Whiplash, Adherence, Recovery, Mobile app
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Blaz BarunUniversity, hospital or other
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 13 Aug 2024 (actual)
- Study completion
- 13 Aug 2024 (actual)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile app (WIapp) group | Experimental | Behavioral: Reminder to exerciseStandard 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 |
| Control group | No intervention | –Standard physical therapy program: 2x10 sessions, 5 times a week, 3-week break in between, written instructions on exercises at home |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reminder to exerciseExercise 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. | Behavioural | Mobile app (WIapp) group |
Primary outcome
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)
10 secondary outcomes
Questionnaire assessment of adherence to exercise
Time frame: 6 months after the injury
Questionnaire assessment of perceived recovery
Time frame: 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 catastrophizing scale
Time frame: baseline
Short Form Health Survey 12
Time frame: baseline
Questionnaire assessment of social functioning
Time frame: baseline
Questionnaire assessment work
Time frame: baseline, 6 months after the injury
Pain catastrophizing scale
Time frame: 6 months after the injury
Short Form Health Survey 12
Time frame: 6 months after the injury
Questionnaire assessment of social functioning
Time frame: 6 months after the injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Derived from this study: PubMed 39682637Barun B, Divic Z, Martinovic Kaliterna D, Poljicanin A, Benzon B, Aljinovic J. Mobile App Intervention Increases Adherence to Home Exercise Program After Whiplash Injury-A Randomized Controlled Trial (RCT). Diagnostics (Basel). 2024 Dec 4;14(23):2729. doi: 10.3390/diagnostics14232729.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aljinović study director
University Hospital of Split
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reminder to exercise in people with Whiplash Injury of Cervical Spine, run by Blaz Barun at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Neck Disability Index from baseline to 6 months after the injury (time frame: baseline, 6 months after the injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05704023, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.