Effectiveness of Telerehabilitation Program in Subacromial Syndrome (Telerehab Sis) (telerehab)

October 10, 2016 updated by: Jose Manuel Pastora Bernal

Effectiveness of Telerehabilitation Program Following Surgery Procedures in Subacromial Syndrome Compared With Traditional Therapy. A Randomized Clinical Trial (Telerehab)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Malaga, Spain
        • Recruiting
        • Faculty of Health Sciences Universidad de Málaga
        • Contact:
          • Jose Manuel Pastora-Bernal
          • Phone Number: 0034658561622
          • Email: jmpastora@uma.es

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Telerehabilitation
Initial Videoconference following telerehabilitation programs self-workout exercise with video support.
Active Comparator: 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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Simple Shoulder Test (SST) score
Time Frame: Initial, 4 weeks, 8 weeks and 12 weeks
Simple Shoulder Test is a validated instrument that features 12 one-dimensional answers questions with dichotomous (Yes / No). It is a short questionnaire (2-3 minutes), easy to understand and fulfill what gives validity and comparability with other subjective questionnaires. The total score of 12 questions (2 related to pain, 7 on the force, and 3 on the range of motion) where 0 is the worst result and 100 if the best shoulder function is measured, calculated based on the number of positive responses multiplied by 100. questionnaire. The internal consistency of the test was measured by Cronbach's alpha = 0.85. We will assess changes in this test score.
Initial, 4 weeks, 8 weeks and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Constant Shoulder test Score
Time Frame: Initial, 4 weeks, 8 weeks and 12 weeks
Constant score is an assessment tool universally used and accepted for shoulder function. It includes a subjective assessment of pain and ability to perform daily activities (work, sport, dream and positioning of the hand in space), and an objective assessment of mobility and strength through physical examination. We will assess changes in this test score.
Initial, 4 weeks, 8 weeks and 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ) (Spanish adaptation)
Time Frame: 12 weeks
Acceptance and usability of telemedicine applications is a prerequisite for identifying potential clinical benefits of this technology. Consequently, it is important to supplement this research with tools to examine the satisfaction and perception of patients.
12 weeks
Direct and Indirect Costs
Time Frame: 12 weeks
This economic analysis is based on the perspective of the health sector, which means that only those for health interventions costs will be considered, and unrelated costs for the patient. Therefore, only the costs associated with the provision of health services in the traditional physiotherapy group telerehabilitación be taken into account.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jose Manuel Pastora Bernal

Collaborators

University of Malaga
Hospital Costa del Sol

Investigators

  • Principal Investigator: Jose Manuel Pastora Bernal, University of Malaga
  • Study Director: Rocío Martín Valero, University of Malaga
  • Study Director: Francisco Javier Barón López, University of Malaga

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

September 14, 2016

First Submitted That Met QC Criteria

September 16, 2016

First Posted (Estimate)

September 21, 2016

Study Record Updates

Last Update Posted (Estimate)

October 11, 2016

Last Update Submitted That Met QC Criteria

October 10, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0761-M1-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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