Clinical trial NCT06794528: Therapeutic Exercise Through Exergames on Mobile Devices for Cervical Rehabilitation
Official title: A Randomized Two-Arm Clinical Trial, Fixed-Assignment Study on Adherence to Therapeutic Exercise in Cervical Rehabilitation Using A Serious Game In Mobile Devices
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neck Pain
Lead sponsor: Universitat de les Illes Balears
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Participants in the study will be adults with non-specific neck pain (cervicalgia) who own a smartphone or tablet, and that give informed consent. Individuals with acute or severe conditions, such as recent surgeries or trauma, will be excluded. Before participation, they will be informed about the study and potential risks. The study is designed as a randomized clinical trial with two groups. The control group will follow a traditional home exercise program with written instructions, while the intervention group will use a personalized mobile app to guide their exercises. All participants will be asked to log their progress and any incidents in a compliance journal.

Eligibility criteria: Inclusion Criteria:

* Persons of legal age with cervicalgia.
* Have a smart mobile device (smartphone or tablet) on which to download the App.

Exclusion Criteria:

* 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.
* Not having a device suitable for installation or lack of experience in the use of smart mobile devices.
* Baseline NDI score of less than 5.
* Presence of red flags:

  * Suspicion of fracture: advanced age, previous trauma, osteoporosis.
  * Suspicion of neurological involvement: loss of sensation in extremities, loss of strength or muscle mass.
  * Suspicion of infection: fever, night sweats.
  * Suspicion of cancer: Previous history of cancer, no improvement in one month of treatment, weight loss, headache, vomiting.
  * Suspicion of systemic disease: headache, fever, malaise, general headache, fever, malaise, unilateral skin rash (herpes).

Primary outcomes:
measure: Level of Compliance of the Exercise Prescription
timeFrame: From admission to discharge, every 15 days, up to two months.
Secondary outcomes:
measure: Changes in Pain Intensity
timeFrame: Baseline and every 15 days, up to two months.
measure: Changes in Neck disability
timeFrame: Baseline and every 15 days, up to two months.
measure: Changes in Cervical Active Range of Motion
timeFrame: Baseline and every 15 days, up to two months.
Other outcomes:
Locations:
city: Palma De Mallorca
country: Spain
facility: University of the Balearic Islands
state: Illes Balears
Study officials:
References:
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