Neck PainRehbeCaNCT06794528
Therapeutic Exercise Through Exergames on Mobile Devices for Cervical Rehabilitation
A study testing RehbeCa mobile application and Home exercise program in people with Neck Pain, run by Universitat de les Illes Balears at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- RehbeCa mobile application and Home exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 16 Jan 2025to May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persons of legal age with cervicalgia.
- Have a smart mobile device (smartphone or tablet) on which to download the App.
Who cannot join
- 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.
Show all 12Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
University of the Balearic Islands
Palma de Mallorca, Balearic Islands, 07122
Iosune Salinas-Bueno, PhD, +34971259512, iosune.salinas@uib.es
Maria Teresa Arbós-Berenguer, PhD, +34971172712, maite.arbos@uib.es
About this study
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
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.
Read the 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.
- Conditions
- Neck Pain
- Being tested
- RehbeCa mobile application, Home exercise program
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehbeCa mobile applicationOther
Also called RehbeCa application system
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.
Home exercise programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Home exercise via mobile App | Experimental | During two months, participants will be asked to use the therapeutic exercise game in the application three times a week. Receives: Other: RehbeCa mobile application |
| Usual home exercise program | Active comparator | During two months, participants will be asked to performed the therapeutic exercise, previously explained, three times a week. Receives: Other: Home exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: From admission to discharge, every 15 days, up to two months.
Secondary outcomes (3)
Changes in Pain Intensity
Pain intensity measured with Visual Analogue Scale (VAS). Possible scores range from 0 (no pain) to 10 (worst possible pain).
Measured: Baseline and every 15 days, up to two months.
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)
Measured: Baseline and every 15 days, up to two months.
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).
Measured: Baseline and every 15 days, up to two months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start16 Jan 2025
- Primary completionApr 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat de les Illes Balears
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iosune Salinas-Bueno, Universitat de les Illes Balears
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794528
- Sponsor's protocol ID
- TED2021-131358A-I00_RCT
- Other IDs
- TED2021-131358A-I00
- Acronym
- RehbeCa
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Socio-demographic data and health data such as pain scores, ROM records or adherence to treatment will be collected deidentified. All data will be recorded in the data processing register RAT Code 034 of the University of the Balearic Islands: 'Therapeutic Exercise Through Exergames on Mobile Devices or Cervical Rehabilitation" All the individual data collected during the trial will be shared, after deidentification. Also, study protocol will be available. Dataset will be available following publication of results, for any purposes, at Institutional Data Repository CORA. RDR, a federated data repository that allows publishing datasets in a FAIR way and following the guidelines of the European Open Science Cloud (EOSC).
Publications
Jahre H, Grotle M, Smedbraten K, Dunn KM, Oiestad BE. Risk factors for non-specific neck pain in young adults. A systematic review. BMC Musculoskelet Disord. 2020 Jun 9;21(1):366. doi: 10.1186/s12891-020-03379-y.
PubMed 32517732Cheng CH, Su HT, Yen LW, Liu WY, Cheng HY. Long-term effects of therapeutic exercise on nonspecific chronic neck pain: a literature review. J Phys Ther Sci. 2015 Apr;27(4):1271-6. doi: 10.1589/jpts.27.1271. Epub 2015 Apr 30.
PubMed 25995604Zronek M, Sanker H, Newcomb J, Donaldson M. The influence of home exercise programs for patients with non-specific or specific neck pain: a systematic review of the literature. J Man Manip Ther. 2016 May;24(2):62-73. doi: 10.1179/2042618613Y.0000000047.
PubMed 27559275Minghelli B. Musculoskeletal spine pain in adolescents: Epidemiology of non-specific neck and low back pain and risk factors. J Orthop Sci. 2020 Sep;25(5):776-780. doi: 10.1016/j.jos.2019.10.008. Epub 2019 Nov 7.
PubMed 31708228Gross AR, Paquin JP, Dupont G, Blanchette S, Lalonde P, Cristie T, Graham N, Kay TM, Burnie SJ, Gelley G, Goldsmith CH, Forget M, Santaguida PL, Yee AJ, Radisic GG, Hoving JL, Bronfort G; Cervical Overview Group. Exercises for mechanical neck disorders: A Cochrane review update. Man Ther. 2016 Aug;24:25-45. doi: 10.1016/j.math.2016.04.005. Epub 2016 Apr 20.
PubMed 27317503Noormohammadpour P, Tayyebi F, Mansournia MA, Sharafi E, Kordi R. A concise rehabilitation protocol for sub-acute and chronic non-specific neck pain. J Bodyw Mov Ther. 2017 Jul;21(3):472-480. doi: 10.1016/j.jbmt.2016.07.005. Epub 2016 Jul 25.
PubMed 28750953Bailey DL, Holden MA, Foster NE, Quicke JG, Haywood KL, Bishop A. Defining adherence to therapeutic exercise for musculoskeletal pain: a systematic review. Br J Sports Med. 2020 Mar;54(6):326-331. doi: 10.1136/bjsports-2017-098742. Epub 2018 Jun 6.
PubMed 29875278Ayed I, Ghazel A, Jaume-I-Capo A, Moya-Alcover G, Varona J, Martinez-Bueso P. Vision-based serious games and virtual reality systems for motor rehabilitation: A review geared toward a research methodology. Int J Med Inform. 2019 Nov;131:103909. doi: 10.1016/j.ijmedinf.2019.06.016. Epub 2019 Jul 10.
PubMed 31557701Manresa-Yee, C., Ponsa, P., Salinas, I., Perales, F.J., Negre, F., Varona, J. (2014). Observing the use of an input device for rehabilitation purposes. Behav. Inf. Technol. 33, 3, 271-282.
Roig-Maimo MF, Manresa-Yee C, Varona J. A Robust Camera-Based Interface for Mobile Entertainment. Sensors (Basel). 2016 Feb 19;16(2):254. doi: 10.3390/s16020254.
PubMed 26907288Ayed I, Ghazel A, Jaume-I-Capo A, Moya-Alcover G, Varona J, Martinez-Bueso P. Feasibility of Kinect-Based Games for Balance Rehabilitation: A Case Study. J Healthc Eng. 2018 Jul 9;2018:7574860. doi: 10.1155/2018/7574860. eCollection 2018.
PubMed 30123443Salinas-Bueno I, Roig-Maimo MF, Martinez-Bueso P, San-Sebastian-Fernandez K, Varona J, Mas-Sanso R. Camera-Based Monitoring of Neck Movements for Cervical Rehabilitation Mobile Applications. Sensors (Basel). 2021 Mar 23;21(6):2237. doi: 10.3390/s21062237.
PubMed 33806813
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06794528
- Acronym / sponsor ID
- RehbeCa / TED2021-131358A-I00_RCT
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universitat de les Illes BalearsUniversity, hospital or other
- Study start
- 16 Jan 2025 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home exercise via mobile App | Experimental | Other: RehbeCa mobile applicationDuring two months, participants will be asked to use the therapeutic exercise game in the application three times a week. |
| Usual home exercise program | Active comparator | Other: Home exercise programDuring two months, participants will be asked to performed the therapeutic exercise, previously explained, three times a week. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Persons of legal age with cervicalgia.
- Have a smart mobile device (smartphone or tablet) on which to download the App.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RehbeCa mobile applicationAlso: RehbeCa application systemThe 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 | Home exercise via mobile App |
| Home exercise programSet 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. | Other | Usual home exercise program |
Primary outcome
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%.
3 secondary outcomes
Changes in Pain Intensity
Time frame: Baseline and every 15 days, up to two months.
Changes in Neck disability
Time frame: Baseline and every 15 days, up to two months.
Changes in Cervical Active Range of Motion
Time frame: Baseline and every 15 days, up to two months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Background: PubMed 32517732Jahre H, Grotle M, Smedbraten K, Dunn KM, Oiestad BE. Risk factors for non-specific neck pain in young adults. A systematic review. BMC Musculoskelet Disord. 2020 Jun 9;21(1):366. doi: 10.1186/s12891-020-03379-y.
- Background: PubMed 25995604Cheng CH, Su HT, Yen LW, Liu WY, Cheng HY. Long-term effects of therapeutic exercise on nonspecific chronic neck pain: a literature review. J Phys Ther Sci. 2015 Apr;27(4):1271-6. doi: 10.1589/jpts.27.1271. Epub 2015 Apr 30.
- Background: PubMed 27559275Zronek M, Sanker H, Newcomb J, Donaldson M. The influence of home exercise programs for patients with non-specific or specific neck pain: a systematic review of the literature. J Man Manip Ther. 2016 May;24(2):62-73. doi: 10.1179/2042618613Y.0000000047.
- Background: PubMed 31708228Minghelli B. Musculoskeletal spine pain in adolescents: Epidemiology of non-specific neck and low back pain and risk factors. J Orthop Sci. 2020 Sep;25(5):776-780. doi: 10.1016/j.jos.2019.10.008. Epub 2019 Nov 7.
- Background: PubMed 27317503Gross AR, Paquin JP, Dupont G, Blanchette S, Lalonde P, Cristie T, Graham N, Kay TM, Burnie SJ, Gelley G, Goldsmith CH, Forget M, Santaguida PL, Yee AJ, Radisic GG, Hoving JL, Bronfort G; Cervical Overview Group. Exercises for mechanical neck disorders: A Cochrane review update. Man Ther. 2016 Aug;24:25-45. doi: 10.1016/j.math.2016.04.005. Epub 2016 Apr 20.
- Background: PubMed 28750953Noormohammadpour P, Tayyebi F, Mansournia MA, Sharafi E, Kordi R. A concise rehabilitation protocol for sub-acute and chronic non-specific neck pain. J Bodyw Mov Ther. 2017 Jul;21(3):472-480. doi: 10.1016/j.jbmt.2016.07.005. Epub 2016 Jul 25.
- Background: PubMed 29875278Bailey DL, Holden MA, Foster NE, Quicke JG, Haywood KL, Bishop A. Defining adherence to therapeutic exercise for musculoskeletal pain: a systematic review. Br J Sports Med. 2020 Mar;54(6):326-331. doi: 10.1136/bjsports-2017-098742. Epub 2018 Jun 6.
- Background: PubMed 31557701Ayed I, Ghazel A, Jaume-I-Capo A, Moya-Alcover G, Varona J, Martinez-Bueso P. Vision-based serious games and virtual reality systems for motor rehabilitation: A review geared toward a research methodology. Int J Med Inform. 2019 Nov;131:103909. doi: 10.1016/j.ijmedinf.2019.06.016. Epub 2019 Jul 10.
- BackgroundManresa-Yee, C., Ponsa, P., Salinas, I., Perales, F.J., Negre, F., Varona, J. (2014). Observing the use of an input device for rehabilitation purposes. Behav. Inf. Technol. 33, 3, 271-282.
- Background: PubMed 26907288Roig-Maimo MF, Manresa-Yee C, Varona J. A Robust Camera-Based Interface for Mobile Entertainment. Sensors (Basel). 2016 Feb 19;16(2):254. doi: 10.3390/s16020254.
- Background: PubMed 30123443Ayed I, Ghazel A, Jaume-I-Capo A, Moya-Alcover G, Varona J, Martinez-Bueso P. Feasibility of Kinect-Based Games for Balance Rehabilitation: A Case Study. J Healthc Eng. 2018 Jul 9;2018:7574860. doi: 10.1155/2018/7574860. eCollection 2018.
- Background: PubMed 33806813Salinas-Bueno I, Roig-Maimo MF, Martinez-Bueso P, San-Sebastian-Fernandez K, Varona J, Mas-Sanso R. Camera-Based Monitoring of Neck Movements for Cervical Rehabilitation Mobile Applications. Sensors (Basel). 2021 Mar 23;21(6):2237. doi: 10.3390/s21062237.
- Individual participant dataSharing planned: Yes. Socio-demographic data and health data such as pain scores, ROM records or adherence to treatment will be collected deidentified. All data will be recorded in the data processing register RAT Code 034 of the University of the Balearic Islands: 'Therapeutic Exercise Through Exergames on Mobile Devices or Cervical Rehabilitation" All the individual data collected during the trial will be shared, after deidentification. Also, study protocol will be available. Dataset will be available following publication of results, for any purposes, at Institutional Data Repository CORA. RDR, a federated data repository that allows publishing datasets in a FAIR way and following the guidelines of the European Open Science Cloud (EOSC).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RehbeCa mobile application and Home exercise program in people with Neck Pain, run by Universitat de les Illes Balears at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iosune Salinas-Bueno, PhD (+34971259512, iosune.salinas@uib.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Compliance of the Exercise Prescription (time frame: From admission to discharge, every 15 days, up to two months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06794528, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.