Use of the Efisiotrack System for Monitoring Patients With Shoulder Orthopedic Injuries

Shoulder Injuries Clinical Trial

Official title:

Use of the Efisiotrack System for Monitoring Prescribed Therapeutic Exercises in Patients With Shoulder Orthopedic Injuries in a Hospital Setting: a Pilot Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06026137
• Other study ID #: JVT002
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Shoulder Injuries
• Wounds and Injuries

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)

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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

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* Note: There are 26 references in all — Click 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.