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

Whiplash Injury of Cervical Spine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05704023
• Other study ID #: 4090457
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2023
• Est. completion date: May 2024

Study information

• Verified date: April 2024
• Source: University of Split, School of Medicine
• Contact: University Hospital Split
• Phone: +38521556111
• Email: office[@]kbsplit.hr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Croatia	University Hospital Split	Split

Sponsors (1)

Lead Sponsor	Collaborator
Blaz Barun

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	baseline, 6 months after the injury
Secondary	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)	6 months after the injury
Secondary	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)	6-months after the injury
Secondary	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	baseline, 6 months after the injury
Secondary	Pain catastrophizing scale	Psychological functioning - (score range from 0-50, a score of 30 or more represents clinically significant level of catastropihizing)	baseline
Secondary	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).	baseline
Secondary	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)	baseline
Secondary	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	baseline, 6 months after the injury
Secondary	Pain catastrophizing scale	Psychological functioning - (score range from 0-50, a score of 30 or more represents clinically significant level of catastropihizing)	6 months after the injury
Secondary	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).	6 months after the injury
Secondary	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)	6 months after the injury