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Recruiting NCT06794528

Therapeutic Exercise Through Exergames on Mobile Devices for Cervical Rehabilitation

No phase Interventional Neck Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RehbeCa mobile application, Home exercise program.
Who it may be relevant to
Registry conditions: Neck Pain. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Other 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
  • 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.

Primary outcome measures

  • Level of Compliance of the Exercise Prescription [Time frame: From admission to discharge, every 15 days, up to two months.]
Secondary outcome measures (3)
  • 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.]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • University of the Balearic Islands — Palma de Mallorca

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. PMID 32517732
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT06794528 · TED2021-131358A-I00_RCT · TED2021-131358A-I00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗