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

Primary Purpose

Shoulder Injuries

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
eFisioTrack Group
Excercises Group
Sponsored by
Universidad Miguel Hernandez de Elche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Injuries focused on measuring rehabilitation, shoulder injury, monitoring device, adherence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital General of ElcheRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

eFisioTrack Group

Excercises Group

Arm Description

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.

Patients who performed the exercise program supervised by the physical physiotherapist in a hospital room.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 18, 2023
Last Updated
September 1, 2023
Sponsor
Universidad Miguel Hernandez de Elche
Collaborators
Hospital General Universitario Elche
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1. Study Identification

Unique Protocol Identification Number
NCT06026137
Brief Title
Use of the Efisiotrack System for Monitoring Patients With Shoulder Orthopedic Injuries
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2023 (Actual)
Primary Completion Date
August 30, 2023 (Actual)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Miguel Hernandez de Elche
Collaborators
Hospital General Universitario Elche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Injuries
Keywords
rehabilitation, shoulder injury, monitoring device, adherence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
eFisioTrack Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Excercises Group
Arm Type
Active Comparator
Arm Description
Patients who performed the exercise program supervised by the physical physiotherapist in a hospital room.
Intervention Type
Procedure
Intervention Name(s)
eFisioTrack Group
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Excercises Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disabilities of Arm, Shoulder and Hand (DASH) score
Description
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.
Time Frame
At baseline and at one month follow-up.
Secondary Outcome Measure Information:
Title
Constant-Murley (CM) score.
Description
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.
Time Frame
At baseline and at one month follow-up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jose-Vicente Toledo-Marhuenda, PhD.
Phone
965 91 92 60
Ext
9260
Email
josetoledo@umh.es
First Name & Middle Initial & Last Name or Official Title & Degree
Sergio Hernández-Sánchez, PhD
Phone
965 91 25 48
Ext
2548
Email
sehesa@umh.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Roses Conde, Ph
Organizational Affiliation
Hospital Generalof Elche
Official's Role
Study Director
Facility Information:
Facility Name
Hospital General of Elche
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Roses Conde, Ph
Phone
966 61 69 00
Ext
6900
Email
jroses@umh.es

12. IPD Sharing Statement

Plan to Share IPD
No
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Use of the Efisiotrack System for Monitoring Patients With Shoulder Orthopedic Injuries

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