Therapeutic Exercise Through Exergames on Mobile Devices for Cervical Rehabilitation

NCT ID: NCT06794528

Last Updated: 2025-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-16

Study Completion Date

2025-05-31

Brief Summary

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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

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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

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Neck Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Home exercise via mobile App

During two months, participants will be asked to use the therapeutic exercise game in the application three times a week.

Group Type EXPERIMENTAL

RehbeCa mobile application

Intervention Type 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.

Usual home exercise program

During two months, participants will be asked to performed the therapeutic exercise, previously explained, three times a week.

Group Type ACTIVE_COMPARATOR

Home exercise program

Intervention Type 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.

Interventions

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RehbeCa mobile application

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.

Intervention Type OTHER

Home exercise program

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.

Intervention Type OTHER

Other Intervention Names

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RehbeCa application system

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitat de les Illes Balears

OTHER

Sponsor Role lead

Responsible Party

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Iosune Salinas-Bueno

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of the Balearic Islands

Palma de Mallorca, Balearic Islands, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Iosune Salinas-Bueno, PhD

Role: CONTACT

+34971259512

Maria Teresa Arbós-Berenguer, PhD

Role: CONTACT

+34971172712

Facility Contacts

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Iosune Salinas-Bueno, PhD

Role: primary

+34971259512

Maria Teresa Arbós-Berenguer, PhD

Role: backup

+34971172712

References

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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.

Reference Type BACKGROUND
PMID: 32517732 (View on PubMed)

Cheng 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.

Reference Type BACKGROUND
PMID: 25995604 (View on PubMed)

Zronek 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.

Reference Type BACKGROUND
PMID: 27559275 (View on PubMed)

Minghelli 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.

Reference Type BACKGROUND
PMID: 31708228 (View on PubMed)

Gross 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.

Reference Type BACKGROUND
PMID: 27317503 (View on PubMed)

Noormohammadpour 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.

Reference Type BACKGROUND
PMID: 28750953 (View on PubMed)

Bailey 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.

Reference Type BACKGROUND
PMID: 29875278 (View on PubMed)

Ayed 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.

Reference Type BACKGROUND
PMID: 31557701 (View on PubMed)

Manresa-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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 26907288 (View on PubMed)

Ayed 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.

Reference Type BACKGROUND
PMID: 30123443 (View on PubMed)

Salinas-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.

Reference Type BACKGROUND
PMID: 33806813 (View on PubMed)

Other Identifiers

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TED2021-131358A-I00

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

TED2021-131358A-I00_RCT

Identifier Type: -

Identifier Source: org_study_id

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