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

Sponsor

Jose Manuel Pastora Bernal (Other)

Overall Status

Unknown status

CT.gov ID

NCT02909920

Collaborator

University of Malaga (Other), Hospital Costa del Sol (Other)

138

Enrollment

Location

Arms

Duration (Months)

17.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Shoulder Impingement Syndrome	Other: Telerehabilitation Other: Traditional Physiotherapy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

138 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2016

Anticipated Primary Completion Date :

Mar 1, 2017

Anticipated Study Completion Date :

May 1, 2017

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

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

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.

Other Outcome Measures

Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ) (Spanish adaptation) [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.
Direct and Indirect Costs [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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