NCT05704023

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

January 20, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 30, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2024

Completed
Last Updated

September 23, 2024

Status Verified

September 1, 2024

Enrollment Period

1.6 years

First QC Date

January 19, 2023

Last Update Submit

September 20, 2024

Conditions

Whiplash Injury of Cervical Spine

Keywords

WhiplashAdherenceRecoveryMobile app

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Questionnaire assessment of adherence to exercise

    6 months after the injury

  • Questionnaire assessment of perceived recovery

    6-months after the injury

  • Change in Visual Analog Scale (VAS) Pain Score from baseline to 6 months after the injury

    baseline, 6 months after the injury

  • Pain catastrophizing scale

    baseline

  • Short Form Health Survey 12

    baseline

  • +5 more secondary outcomes

Study Arms (2)

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

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

Interventions

Reminder to exerciseBEHAVIORAL

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.

Mobile app (WIapp) group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Split

Split, 21000, Croatia

Location

Related Publications (1)

  • 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.

    PMID: 39682637DERIVED

MeSH Terms

Conditions

Whiplash Injuries

Condition Hierarchy (Ancestors)

Neck InjuriesWounds and Injuries

Study Officials

  • Aljinović

    University Hospital of Split

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 19, 2023

First Posted

January 30, 2023

Study Start

January 20, 2023

Primary Completion

August 13, 2024

Study Completion

August 13, 2024

Last Updated

September 23, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

Locations

CR(1)