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

NCT06026137 | Unknown

• 1 other identifier: JVT002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Injuries

Keywords

rehabilitation; shoulder injury; monitoring device; adherence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Constant-Murley (CM) score.

  At baseline and at one month follow-up.

Study Arms (2)

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.

Procedure: eFisioTrack Group

Excercises Group

ACTIVE COMPARATOR

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

Procedure: Excercises Group

Interventions

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.

eFisioTrack Group

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.

Excercises Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead
• Hospital General Universitario Elche: collaborator

Study Sites (1)

Hospital General of Elche

Elche, Alicante, 03203, Spain

RECRUITING

Related Publications (26)

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MeSH Terms

Conditions

Shoulder Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Jorge Roses Conde, Ph

  Hospital Generalof Elche

  STUDY DIRECTOR

Central Study Contacts

Jose-Vicente Toledo-Marhuenda, PhD.

CONTACT

965 91 92 60; josetoledo@umh.es

Sergio Hernández-Sánchez, PhD

CONTACT

965 91 25 48; sehesa@umh.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: September 6, 2023
• Study Start: June 29, 2023
• Primary Completion: August 30, 2023
• Study Completion: September 30, 2023
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)