Therapeutic Exercise Through Exergames on Mobile Devices for Cervical Rehabilitation

Not Applicable

Recruiting

• Conditions: Neck Pain

• Registration Number: NCT06794528
• Lead Sponsor: Universitat de les Illes Balears

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.

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-16
• Study First Submitted: 2025-01-20
• Study First Submitted QC: 2025-01-20
• Last Update Submitted: 2025-01-26
• Study First Posted: 2025-01-27
• Last Update Posted: 2025-01-28
• Primary Completion: 2025-04
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Level of Compliance of the Exercise Prescription	From admission to discharge, every 15 days, up to two months.	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%.

Secondary Outcome Measures

Name	Time	Method
Changes in Pain Intensity	Baseline and every 15 days, up to two months.	Pain intensity measured with Visual Analogue Scale (VAS). Possible scores range from 0 (no pain) to 10 (worst possible pain).
Changes in Neck disability	Baseline and every 15 days, up to two months.	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)
Changes in Cervical Active Range of Motion	Baseline and every 15 days, up to two months.	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).

Trial Locations

Locations (1)

University of the Balearic Islands; 🇪🇸 Palma De Mallorca, Illes Balears, Spain