NCT Number: NCT06794528
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Palma de Mallorca, Balearic Islands, 07122, Spain
Location status: Recruiting
Iosune Salinas-Bueno, PhD
CONTACT
Iosune Salinas-Bueno, PhD
PRINCIPAL_INVESTIGATOR
Maria Francesca Roig Maimó, PhD
PRINCIPAL_INVESTIGATOR
Maria Teresa Arbós-Berenguer, PhD
CONTACT
Nuria Gómez-Molina, PhD
SUB_INVESTIGATOR
Núria García-Dopico, PhD
SUB_INVESTIGATOR
Pau Martínez-Bueso, PhD
SUB_INVESTIGATOR
Ramon Mas-Sansó, PhD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
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%.
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).
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)
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).
Contact information is provided by the study sponsor or research team.
Iosune Salinas-Bueno, PhD
CONTACT
Maria Teresa Arbós-Berenguer, PhD
CONTACT
Universitat de les Illes Balears
Other
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
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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