Effectiveness of Telerehabilitation Program in Subacromial Syndrome (Telerehab Sis)
NCT ID: NCT02909920
Last Updated: 2016-10-11
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
138 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-09-30
Study Completion Date
2017-05-31
Brief Summary
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Shoulder pain is a common and high prevalence in the general population. Subacromial Syndrome (Shoulder Impingement Syndrome (SIS)) is the most frequent cause. SIS patients suffering pain, muscle weakness and loss of movement in the affected joint. Initial treatment of the SIS is predominantly conservative. Surgical option has high success rates and is often used when conservative strategy fails. Traditional Physiotherapy and Postoperative exercises is needed to the recovery of joint range, muscle strength, stability and functionality. This Research evaluates the feasibility and effectiveness of a telerehabilitatión Program in SIS after surgery compared with traditional therapy.
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Detailed Description
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In addition to traditional physiotherapy, Telerehabilitation programs have proven their effectiveness, validity, noninferiority and important advantages in various neurological, cognitive diseases and musculoskeletal disorders; meaning an opportunity to define new social and intervention policies.
Subjects are randomly assigned to 1) Telerehabilitation Group 2) Traditional Therapy Group. After randomization, patients in both groups received an initial evaluation. Data will be collected by a blinded evaluator.
The Telerehabilitation group receives a standardized and customized exercises to perform, through a web application that allows the Physiotherapist generate videos, images and parameters of each exercise program and send them via email for each patient.
Telerehabilitation program describes the exercises to be performed, the number of repetitions depending on the level of training and criteria for progression.
Patients are initially supervised by a physiotherapist who will conduct three training sessions through individual videoconference, to ensure proper execution of exercises and encourage patient adherence. Patients are instructed to perform self-workout video exercises following Telerehabilitation program as well as a supporting document we call Telerehabilitation Manual Patient.
Traditional group receives assistance in a physiotherapy center through the usual procedure of rehabilitation in Spain, personalized therapy consisting of 1 to 1 with a physical therapist and exercise programs at home.
Subjects are randomly assigned to 1) Telerehabilitation Group 2) Traditional Therapy Group. After randomization, patients in both groups received an initial evaluation. Data will be collected by a blinded evaluator.
The Telerehabilitation group receives a standardized and customized exercises to perform, through a web application that allows the Physiotherapist generate videos, images and parameters of each exercise program and send them via email for each patient.
Telerehabilitation program describes the exercises to be performed, the number of repetitions depending on the level of training and criteria for progression.
Patients are initially supervised by a physiotherapist who will conduct three training sessions through individual videoconference, to ensure proper execution of exercises and encourage patient adherence. Patients are instructed to perform self-workout video exercises following Telerehabilitation program as well as a supporting document we call Telerehabilitation Manual Patient.
Traditional group receives assistance in a physiotherapy center through the usual procedure of rehabilitation in Spain, personalized therapy consisting of 1 to 1 with a physical therapist and exercise programs at home.
Conditions
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Shoulder Impingement Syndrome
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
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Telerehabilitation
The Telerehabilitation group receives a standardized and customized exercises through a web application that allows the Physiotherapist generate videos, images and parameters of each exercise program and send them via email for each patient. Patients are initially supervised by a physiotherapist who will conduct videoconference sessions to ensure proper execution of exercises and encourage patient adherence.
Group Type
EXPERIMENTAL
Telerehabilitation
Intervention Type
OTHER
Initial Videoconference following telerehabilitation programs self-workout exercise with video support.
Traditional Physiotherapy
Traditional Physiotherapy group receives assistance in a physiotherapy center through the usual procedure of rehabilitation in Spain consisting in personalized therapy 1 to 1 with a physical therapist and exercise programs for home.
Group Type
ACTIVE_COMPARATOR
Traditional Physiotherapy
Intervention Type
OTHER
Traditional Physiotherapy receives assistance in a physiotherapy center with personalized therapy consisting of 1 to 1 with a physical therapist (Manual Therapy, home exercise programs and other physiotherapy techniques).
Interventions
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Telerehabilitation
Initial Videoconference following telerehabilitation programs self-workout exercise with video support.
Intervention Type
OTHER
Traditional Physiotherapy
Traditional Physiotherapy receives assistance in a physiotherapy center with personalized therapy consisting of 1 to 1 with a physical therapist (Manual Therapy, home exercise programs and other physiotherapy techniques).
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* Adult between 18 and 65 years
* Subacromial Syndrome Diagnosis ICD-9 CM 726.10, 726.12, 726.19 issued by specialist in Orthopaedic Surgery and Rehabilitation Specialist
* Receive Surgical Procedure (arthroscopy or open approach (subacromial decompression with partial acromioplasty, with or without coracoacromial release) and prescription of rehabilitation process.
* He lives in Spain during the investigation period
* Provides in home computer with internet technology (personal computer, laptop, tablet or Smartphone)
* Skills and knowledge to access email
* Subacromial Syndrome Diagnosis ICD-9 CM 726.10, 726.12, 726.19 issued by specialist in Orthopaedic Surgery and Rehabilitation Specialist
* Receive Surgical Procedure (arthroscopy or open approach (subacromial decompression with partial acromioplasty, with or without coracoacromial release) and prescription of rehabilitation process.
* He lives in Spain during the investigation period
* Provides in home computer with internet technology (personal computer, laptop, tablet or Smartphone)
* Skills and knowledge to access email
Exclusion Criteria
* Previously Surgery intervention in same shoulder.
* Patients receiving non-surgical procedure based on the recommendations for Subacromial Syndrome
* Unfit cognitive ability to use technological tools
* Patients receiving non-surgical procedure based on the recommendations for Subacromial Syndrome
* Unfit cognitive ability to use technological tools
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Jose Manuel Pastora Bernal
OTHER
Sponsor Role
lead
University of Malaga
OTHER
Sponsor Role
collaborator
Hospital Costa del Sol
OTHER
Sponsor Role
collaborator
Responsible Party
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Jose Manuel Pastora Bernal
MSc Research in Health Sciences (Phd Health Sciences Student)
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Jose Manuel Pastora Bernal
Role: PRINCIPAL_INVESTIGATOR
University of Malaga
Rocio Martín Valero
Role: STUDY_DIRECTOR
University of Malaga
Francisco Javier Barón López
Role: STUDY_DIRECTOR
University of Malaga
Locations
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Faculty of Health Sciences Universidad de Málaga
Málaga, Malaga, Spain
Site Status
RECRUITING
Countries
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Spain
Central Contacts
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Facility Contacts
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References
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DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0761-M1-16
Identifier Type: -
Identifier Source: org_study_id
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