Therapeutic Exercise Through Exergames on Mobile Devices for Cervical Rehabilitation

NCT06794528 | Recruiting

• 2 other identifiers: TED2021-131358A-I00_RCTTED2021-131358A-I00
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (1)

• 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%.

  From admission to discharge, every 15 days, up to two months.

Secondary Outcomes (3)

• Changes in Pain Intensity

  Baseline and every 15 days, up to two months.

• Changes in Neck disability

  Baseline and every 15 days, up to two months.

• Changes in Cervical Active Range of Motion

  Baseline and every 15 days, up to two months.

Study Arms (2)

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.

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.

Other: Home exercise program

Interventions

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.

Also known as: RehbeCa application system

Home exercise via mobile App

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.

Usual home exercise program

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons of legal age with cervicalgia.
• Have a smart mobile device (smartphone or tablet) on which to download the App.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universitat de les Illes Balears: lead

Study Sites (1)

University of the Balearic Islands

Palma de Mallorca, Balearic Islands, 07122, Spain

RECRUITING

Related Publications (12)

• 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.

  PMID: 32517732 BACKGROUND

• 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.

  PMID: 25995604 BACKGROUND

• 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.

  PMID: 27559275 BACKGROUND

• 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.

  PMID: 31708228 BACKGROUND

• 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.

  PMID: 27317503 BACKGROUND

• 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.

  PMID: 28750953 BACKGROUND

• 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.

  PMID: 29875278 BACKGROUND

• 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.

  PMID: 31557701 BACKGROUND

• 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.

  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.

  PMID: 26907288 BACKGROUND

• 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.

  PMID: 30123443 BACKGROUND

• 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.

  PMID: 33806813 BACKGROUND

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Iosune Salinas-Bueno, PhD

CONTACT

+34971259512; iosune.salinas@uib.es

Maria Teresa Arbós-Berenguer, PhD

CONTACT

+34971172712; maite.arbos@uib.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 27, 2025
• Study Start: January 16, 2025
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Following publication of results, no end date.
• Access Criteria: Available

Locations

ES (1)