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| Name | Class |
|---|---|
| Hospital General Universitario Elche | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eFisioTrack Group | Experimental | Use of the eFisioTrack platform in the experimental group to perform active exercises as part of their shoulder rehabilitation. These will. bee performed independently by each patient in a hospital room, using the efisioTrack system without supervision by the physiotherapist. The subjects will be previously instructed in the use of the system in two 20-minute sessions. The type of exercise and its parameters will be chosen and progressed considering the functional status of the patient and being similar to those executed under the physiotherapist's supervision. |
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| Excercises Group | Active Comparator | Patients who performed the exercise program supervised by the physical physiotherapist in a hospital room. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eFisioTrack Group | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jose-Vicente Toledo-Marhuenda, PhD. | Contact | 965 91 92 60 | 9260 | josetoledo@umh.es |
| Sergio Hernández-Sánchez, PhD | Contact | 965 91 25 48 | 2548 | sehesa@umh.es |
| Name | Affiliation | Role |
|---|---|---|
| Jorge Roses Conde, Ph | Hospital Generalof Elche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General of Elche | Recruiting | Elche | Alicante | 03203 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22349588 | Background | 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. | |
| 36597130 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jul 17, 2023 | Jul 18, 2023 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D000070599 | Shoulder Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Excercises Group | Procedure | 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. |
|
| At baseline and at one month follow-up. |
| 30441330 | Background | 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. |
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| 35699989 | Result | 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. |
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