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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06026137
Other study ID # JVT002
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 29, 2023
Est. completion date September 30, 2023

Study information

Verified date September 2023
Source Universidad Miguel Hernandez de Elche
Contact Jose-Vicente Toledo-Marhuenda, PhD.
Phone 965 91 92 60
Email josetoledo@umh.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the effect on clinical variables of monitoring exercises prescribed for shoulder injury rehabilitation with the eFisioTrack platform in patients of the Rehabilitation Service at University Hospital of Elche.


Description:

Patients who be referred to the rehabilitation service of the University Hospital of Elche (Spain) for physiotherapy treatment (manual therapy, exercise, stretching, and electrotherapy) after suffering orthopedic injury or surgery in the shoulder joint complex will be considered for enrollment in the study. Patients will performed the prescribed physical therapy treatment, at least three times per week in sessions of 45 minutes in the hospital setting (application of manual therapy and physical modalities as ultrasound, heat/cold, laser, magnetic field therapy) together with completion of the exercise program for functional recovery of the upper extremity (exercises for muscle strength, scapular stability, joint mobility, and proprioception). Following baseline examination, patients will be randomly assigned to either physiotherapist-supervised exercise (control group) or monitoring by the eFisioTrack system (experimental group) to perform active exercises as part of their shoulder rehabilitation. These will be performed independently by each patient in a hospital room without supervision by the physiotherapist. The following patient-reported outcome measures will be used to assess participants' shoulder pain and function: the Disabilities of Arm, Shoulder and Hand (DASH) score and the Constant-Murley (CM) score. All participants will be assessed at baseline on their first visit to the physical therapy area and at one-month follow-up.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date September 30, 2023
Est. primary completion date August 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Be at least 18 years old and be able to read and understand Spanish. - Suffer a traumatic or degenerative shoulder injury, with or without surgical treatment. - Have a prescription for rehabilitative physical therapy that includes active exercises. Exclusion Criteria: -Had a concomitant injury on an upper extremity or the cervical spine at the time of participation or sequelae of previous injuries in the area.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
eFisioTrack Group
Application of manual therapy and physical modalities together with completion of the exercise program for functional recovery of the upper extremity using the efisioTrack system without supervision by the physiotherapist.
Excercises Group
Application of manual therapy and physical modalities together with completion of the exercise program for functional recovery of the upper extremity supervised by the physical physiotherapist in a hospital room.

Locations

Country Name City State
Spain Hospital General of Elche Elche Alicante

Sponsors (2)

Lead Sponsor Collaborator
Universidad Miguel Hernandez de Elche Hospital General Universitario Elche

Country where clinical trial is conducted

Spain, 

References & Publications (26)

Adie K, Schofield C, Berrow M, Wingham J, Humfryes J, Pritchard C, James M, Allison R. Does the use of Nintendo Wii SportsTM improve arm function? Trial of WiiTM in Stroke: a randomized controlled trial and economics analysis. Clin Rehabil. 2017 Feb;31(2) — View Citation

Anwar N, Karimi H, Ahmad A, Gilani SA, Khalid K, Aslam AS, Hanif A. Virtual Reality Training Using Nintendo Wii Games for Patients With Stroke: Randomized Controlled Trial. JMIR Serious Games. 2022 Jun 13;10(2):e29830. doi: 10.2196/29830. — View Citation

Babatunde OO, Ensor J, Littlewood C, Chesterton L, Jordan JL, Corp N, Wynne-Jones G, Roddy E, Foster NE, van der Windt DA. Comparative effectiveness of treatment options for subacromial shoulder conditions: a systematic review and network meta-analysis. T — View Citation

Baroni MP, Jacob MFA, Rios WR, Fandim JV, Fernandes LG, Chaves PI, Fioratti I, Saragiotto BT. The state of the art in telerehabilitation for musculoskeletal conditions. Arch Physiother. 2023 Jan 4;13(1):1. doi: 10.1186/s40945-022-00155-0. — View Citation

Burns D, Boyer P, Razmjou H, Richards R, Whyne C. Adherence Patterns and Dose Response of Physiotherapy for Rotator Cuff Pathology: Longitudinal Cohort Study. JMIR Rehabil Assist Technol. 2021 Mar 11;8(1):e21374. doi: 10.2196/21374. — View Citation

Carbonaro N, Lucchesi I, Lorusssi F, Tognetti A. Tele-monitoring and tele-rehabilitation of the shoulder muscular-skeletal diseases through wearable systems. Annu Int Conf IEEE Eng Med Biol Soc. 2018 Jul;2018:4410-4413. doi: 10.1109/EMBC.2018.8513371. — View Citation

Carnevale A, Longo UG, Schena E, Massaroni C, Lo Presti D, Berton A, Candela V, Denaro V. Wearable systems for shoulder kinematics assessment: a systematic review. BMC Musculoskelet Disord. 2019 Nov 15;20(1):546. doi: 10.1186/s12891-019-2930-4. — View Citation

Correia FD, Molinos M, Luis S, Carvalho D, Carvalho C, Costa P, Seabra R, Francisco G, Bento V, Lains J. Digitally Assisted Versus Conventional Home-Based Rehabilitation After Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial. Am J Phys Med — View Citation

Eriksson L, Lindstrom B, Ekenberg L. Patients' experiences of telerehabilitation at home after shoulder joint replacement. J Telemed Telecare. 2011;17(1):25-30. doi: 10.1258/jtt.2010.100317. Epub 2010 Nov 12. — View Citation

Franchignoni F, Vercelli S, Giordano A, Sartorio F, Bravini E, Ferriero G. Minimal clinically important difference of the disabilities of the arm, shoulder and hand outcome measure (DASH) and its shortened version (QuickDASH). J Orthop Sports Phys Ther. 2 — View Citation

Grassi FA, Tajana MS. The normalization of data in the Constant-Murley score for the shoulder. A study conducted on 563 healthy subjects. Chir Organi Mov. 2003 Jan-Mar;88(1):65-73. English, Italian. — View Citation

Greenberg DL. Evaluation and treatment of shoulder pain. Med Clin North Am. 2014 May;98(3):487-504. doi: 10.1016/j.mcna.2014.01.016. Epub 2014 Mar 22. — View Citation

Hervas MT, Navarro Collado MJ, Peiro S, Rodrigo Perez JL, Lopez Mateu P, Martinez Tello I. [Spanish version of the DASH questionnaire. Cross-cultural adaptation, reliability, validity and responsiveness]. Med Clin (Barc). 2006 Sep 30;127(12):441-7. doi: 10.1157/13093053. Spanish. — View Citation

Holmgren T, Bjornsson Hallgren H, Oberg B, Adolfsson L, Johansson K. Effect of specific exercise strategy on need for surgery in patients with subacromial impingement syndrome: randomised controlled study. BMJ. 2012 Feb 20;344:e787. doi: 10.1136/bmj.e787. — View Citation

Kachingwe AF, Phillips B, Sletten E, Plunkett SW. Comparison of manual therapy techniques with therapeutic exercise in the treatment of shoulder impingement: a randomized controlled pilot clinical trial. J Man Manip Ther. 2008;16(4):238-47. doi: 10.1179/1 — View Citation

Kitis A, Celik E, Aslan UB, Zencir M. DASH questionnaire for the analysis of musculoskeletal symptoms in industry workers: a validity and reliability study. Appl Ergon. 2009 Mar;40(2):251-5. doi: 10.1016/j.apergo.2008.04.005. Epub 2008 Jun 16. — View Citation

Kromer TO, Tautenhahn UG, de Bie RA, Staal JB, Bastiaenen CH. Effects of physiotherapy in patients with shoulder impingement syndrome: a systematic review of the literature. J Rehabil Med. 2009 Nov;41(11):870-80. doi: 10.2340/16501977-0453. — View Citation

Lucas J, van Doorn P, Hegedus E, Lewis J, van der Windt D. A systematic review of the global prevalence and incidence of shoulder pain. BMC Musculoskelet Disord. 2022 Dec 8;23(1):1073. doi: 10.1186/s12891-022-05973-8. — View Citation

Page MJ, Green S, McBain B, Surace SJ, Deitch J, Lyttle N, Mrocki MA, Buchbinder R. Manual therapy and exercise for rotator cuff disease. Cochrane Database Syst Rev. 2016 Jun 10;2016(6):CD012224. doi: 10.1002/14651858.CD012224. — View Citation

Paraskevopoulos E, Plakoutsis G, Chronopoulos E, Maria P. Effectiveness of Combined Program of Manual Therapy and Exercise Vs Exercise Only in Patients With Rotator Cuff-related Shoulder Pain: A Systematic Review and Meta-analysis. Sports Health. 2022 Dec — View Citation

Pastora-Bernal JM, Martin-Valero R, Baron-Lopez FJ, Moyano NG, Estebanez-Perez MJ. Telerehabilitation after arthroscopic subacromial decompression is effective and not inferior to standard practice: Preliminary results. J Telemed Telecare. 2018 Jul;24(6): — View Citation

Rizzo JR, Thai P, Li EJ, Tung T, Hudson TE, Herrera J, Raghavan P. Structured Wii protocol for rehabilitation of shoulder impingement syndrome: A pilot study. Ann Phys Rehabil Med. 2017 Nov;60(6):363-370. doi: 10.1016/j.rehab.2016.10.004. Epub 2017 Mar 15 — View Citation

Roy JS, MacDermid JC, Woodhouse LJ. A systematic review of the psychometric properties of the Constant-Murley score. J Shoulder Elbow Surg. 2010 Jan;19(1):157-64. doi: 10.1016/j.jse.2009.04.008. — View Citation

Ruiz-Fernandez D, Marin-Alonso O, Soriano-Paya A, Garcia-Perez JD. eFisioTrack: a telerehabilitation environment based on motion recognition using accelerometry. ScientificWorldJournal. 2014 Jan 12;2014:495391. doi: 10.1155/2014/495391. eCollection 2014. — View Citation

Sliepen M, Lipperts M, Tjur M, Mechlenburg I. Use of accelerometer-based activity monitoring in orthopaedics: benefits, impact and practical considerations. EFORT Open Rev. 2020 Jan 28;4(12):678-685. doi: 10.1302/2058-5241.4.180041. eCollection 2019 Dec. — View Citation

Tate AR, McClure PW, Young IA, Salvatori R, Michener LA. Comprehensive impairment-based exercise and manual therapy intervention for patients with subacromial impingement syndrome: a case series. J Orthop Sports Phys Ther. 2010 Aug;40(8):474-93. doi: 10.2 — View Citation

* Note: There are 26 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Disabilities of Arm, Shoulder and Hand (DASH) score DASH - Measures symptoms and degree of function related to a disorder in the upper extremity. The DASH Outcome Measure is scored in two components: the disability/symptom section (30 items, scored 1-5) and the optional high performance Sport/Music or Work section (4 items, scored 1-5). At least 27 of the 30 items must be completed for a score to be calculated. The assigned values for all completed responses are simply summed and averaged, producing a score out of five. This value is then transformed to a score out of 100 by subtracting one and multiplying by 25. This transformation is done to make the score easier to compare to other measures scaled on a 0-100 scale. A higher score indicates greater disability. At baseline and at one month follow-up.
Secondary Constant-Murley (CM) score. CMS - specific instrument for assessing the shoulder joint: pain; ability to perform daily activities; mobility and strength. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function. At baseline and at one month follow-up.
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