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NCT Number: NCT06794528

Therapeutic Exercise Through Exergames on Mobile Devices for Cervical Rehabilitation

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.

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Key information

Conditions

Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of the Balearic Islands

Palma de Mallorca, Balearic Islands, 07122, Spain

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

RehbeCa mobile application

Other

The 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.

Other names: RehbeCa application system

Home exercise program

Other

Set 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.

Primary outcomes

  1. Level of Compliance of the Exercise Prescription

    Time frame: 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 outcomes

  1. Changes in Pain Intensity

    Time frame: 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).

  2. Changes in Neck disability

    Time frame: 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)

  3. Changes in Cervical Active Range of Motion

    Time frame: 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).

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Universitat de les Illes Balears

Other

Registry information

Official study 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

Acronym: RehbeCa

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 27, 2025
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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