Therapeutic Exercise Through Exergames on Mobile Devices for Cervical Rehabilitation
ConditionNeck Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversitat de les Illes Balears
About this trial
The objective of this study is to determine whether performing cervical therapeutic exercises using a serious game through a mobile application enhances treatment adherence compared to performing the same exercises at home following standard practice.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Persons of legal age with cervicalgia.
Have a smart mobile device (smartphone or tablet) on which to download the App.
Disqualifiers
Acute musculoskeletal pathological processes or exacerbation (less than 15 days of evolution). Includes presentation of symptoms such as paraesthesia, radiating pain, loss of strength in the upper limb.
Episodes of severe pain more than 15 days of evolution.
Accident with cervical or dorsal injury within the last month.
Refusing to sign the informed consent.
Trial design
Design model
Parallel
Treatments tested in this trial
RehbeCa mobile application
Other interventionThe system consists of a mobile application (to be used by patients) and a web application (to be used by physiotherapists) that allows monitoring of the patient's performance without the need for attendance, thus facilitating telerehabilitation. The mobile application consists of a serious game that aims to induce the patient to perform neck exercises, adapting to their capacity and evolution at all times through artificial intelligence. The patient's interaction with the mobile application is based on the integration of a vision-based head-tracker to track the movements of the patient's head. The web application aims to provide professionals with a tool to monitor the evolution of their patients through the data captured by the mobile application.
Home exercise program
Other interventionSet of therapeutic exercises to be carried out at home. They are taught face-to-face, and also printed on a leaflet that is delivered to the participant.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Home exercise via mobile AppExperimental treatment 1 intervention
Group B: Usual home exercise programActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Level of Compliance of the Exercise Prescription
The level of compliance is a percentage showing the difference between the self-reported performed sessions, reflected in the compliance diary, and the prescribed sessions.Possible score ranges from 0% to 100%, considering compliant participants over 80%.
Time frame
From admission to discharge, every 15 days, up to two months.Secondary outcomes
1
Changes in Pain Intensity
Pain intensity measured with Visual Analogue Scale (VAS). Possible scores range from 0 (no pain) to 10 (worst possible pain).
Time frame
Baseline and every 15 days, up to two months.2
Changes in Neck disability
Level of disability caused by neck pain, measured by Neck Disability Index (NDI) questionnaire. NDI is widely used to evaluate the impact of neck pain on daily activities. It is a questionnaire with 10 items about pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. Item responses range from 0 (no pain) to 5 (worst imaginable pain). The 10 responses are summed to a score from 0 to 50 with higher scores indicating more disability. The NDI categories are no disability (0-4 points), mild disability (5-14 points), moderate disability (15-24 points), severe disability (25-34 points) or complete disability (35-50 points)
Time frame
Baseline and every 15 days, up to two months.3
Changes in Cervical Active Range of Motion
Active Range of Motion (ROM) of the neck, measured recording real-time movements with validated ENLAZA inertial sensors (Werium Assistive Solutions S.L., 2022). ROM measurements collected will be flexion (0-45º), extension (0-45º), lateral flexion (0-45º each side), and neck rotation (0-70º each side).
Time frame
Baseline and every 15 days, up to two months.Sponsors and contacts
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Source ClinicalTrials.gov