Effectiveness of Telerehabilitation Program in Subacromial Syndrome (Telerehab Sis)

Not Applicable

• Conditions: Shoulder Impingement Syndrome
• Interventions: Other: Telerehabilitation; Other: Traditional Physiotherapy

• Registration Number: NCT02909920
• Lead Sponsor: Jose Manuel Pastora Bernal

Brief Summary

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.

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 Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-14
• Study First Submitted QC: 2016-09-16
• Study First Posted: 2016-09-21
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-10
• Last Update Posted: 2016-10-11
• Primary Completion: 2017-03
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 138

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telerehabilitation	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.
Traditional Physiotherapy	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.

Primary Outcome Measures

Name	Time	Method
Changes in Simple Shoulder Test (SST) score	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.

Secondary Outcome Measures

Name	Time	Method
Changes in Constant Shoulder test Score	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.

Trial Locations

Locations (1)

Faculty of Health Sciences Universidad de Málaga; 🇪🇸 Malaga, Spain