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

Primary Purpose

Whiplash Injury of Cervical Spine

Status
Not yet recruiting
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Reminder to exercise
Sponsored by
Blaz Barun
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Whiplash Injury of Cervical Spine focused on measuring Whiplash, Adherence, Recovery, Mobile app

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University Hospital Split

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mobile app (WIapp) group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
January 19, 2023
Last Updated
January 27, 2023
Sponsor
Blaz Barun
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1. Study Identification

Unique Protocol Identification Number
NCT05704023
Brief Title
Effects of a Mobile App on Adherence to Daily Exercise and Recovery After Whiplash Injury
Official Title
Effects of a Mobile App on Adherence to Daily Exercise and Recovery After Whiplash Injury - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Blaz Barun

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Whiplash Injury of Cervical Spine
Keywords
Whiplash, Adherence, Recovery, Mobile app

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mobile app (WIapp) group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Standard physical therapy program: 2x10 sessions, 5 times a week, 3-week break in between, written instructions on exercises at home
Intervention Type
Behavioral
Intervention Name(s)
Reminder to exercise
Intervention Description
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 Outcome Measure Information:
Title
Change in Neck Disability Index from baseline to 6 months after the injury
Description
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)
Time Frame
baseline, 6 months after the injury
Secondary Outcome Measure Information:
Title
Questionnaire assessment of adherence to exercise
Description
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)
Time Frame
6 months after the injury
Title
Questionnaire assessment of perceived recovery
Description
Perceived recovery - a 3-point Likert scale on perceived recovery (where 1 indicates non-recovery and 3 indicates full recovery)
Time Frame
6-months after the injury
Title
Change in Visual Analog Scale (VAS) Pain Score from baseline to 6 months after the injury
Description
Pain intensity - ranging from 0 = no pain, to 10 = maximum pain
Time Frame
baseline, 6 months after the injury
Title
Pain catastrophizing scale
Description
Psychological functioning - (score range from 0-50, a score of 30 or more represents clinically significant level of catastropihizing)
Time Frame
baseline
Title
Short Form Health Survey 12
Description
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).
Time Frame
baseline
Title
Questionnaire assessment of social functioning
Description
A 5-point Likert scale regarding interference of physical or emotional problems with social function (where 1 indicates constant interference and 5 indicates never)
Time Frame
baseline
Title
Questionnaire assessment work
Description
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
Time Frame
baseline, 6 months after the injury
Title
Pain catastrophizing scale
Description
Psychological functioning - (score range from 0-50, a score of 30 or more represents clinically significant level of catastropihizing)
Time Frame
6 months after the injury
Title
Short Form Health Survey 12
Description
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).
Time Frame
6 months after the injury
Title
Questionnaire assessment of social functioning
Description
A 5-point Likert scale regarding interference of physical or emotional problems with social function (where 1 indicates constant interference and 5 indicates never)
Time Frame
6 months after the injury

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
University Hospital Split
Phone
+38521556111
Email
office@kbsplit.hr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aljinović
Organizational Affiliation
University Hospital Split
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Split
City
Split
ZIP/Postal Code
21000
Country
Croatia

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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