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

Primary Purpose

Shoulder Impingement Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Telerehabilitation
Traditional Physiotherapy
Sponsored by
Jose Manuel Pastora Bernal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Impingement Syndrome focused on measuring Telerehabilitation, Physiotherapy, Surgery, Telemedicine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Faculty of Health Sciences Universidad de MálagaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telerehabilitation

Traditional Physiotherapy

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Changes in Simple Shoulder Test (SST) score
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
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.

Full Information

First Posted
September 14, 2016
Last Updated
October 10, 2016
Sponsor
Jose Manuel Pastora Bernal
Collaborators
University of Malaga, Hospital Costa del Sol
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1. Study Identification

Unique Protocol Identification Number
NCT02909920
Brief Title
Effectiveness of Telerehabilitation Program in Subacromial Syndrome (Telerehab Sis)
Acronym
telerehab
Official Title
Effectiveness of Telerehabilitation Program Following Surgery Procedures in Subacromial Syndrome Compared With Traditional Therapy. A Randomized Clinical Trial (Telerehab)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jose Manuel Pastora Bernal
Collaborators
University of Malaga, Hospital Costa del Sol

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement Syndrome
Keywords
Telerehabilitation, Physiotherapy, Surgery, Telemedicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation
Arm Type
Experimental
Arm Description
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.
Arm Title
Traditional Physiotherapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Telerehabilitation
Intervention Description
Initial Videoconference following telerehabilitation programs self-workout exercise with video support.
Intervention Type
Other
Intervention Name(s)
Traditional Physiotherapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
Changes in Simple Shoulder Test (SST) score
Description
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.
Time Frame
Initial, 4 weeks, 8 weeks and 12 weeks
Secondary Outcome Measure Information:
Title
Changes in Constant Shoulder test Score
Description
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.
Time Frame
Initial, 4 weeks, 8 weeks and 12 weeks
Other Pre-specified Outcome Measures:
Title
Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ) (Spanish adaptation)
Description
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.
Time Frame
12 weeks
Title
Direct and Indirect Costs
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jose Manuel Pastora Bernal
Phone
0034 658561622
Email
jmpastora@uma.es
First Name & Middle Initial & Last Name or Official Title & Degree
Jose Manuel Pastora Bernal
Phone
0034 658561622
Email
jospasber@uma.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Manuel Pastora Bernal
Organizational Affiliation
University of Malaga
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rocio Martín Valero
Organizational Affiliation
University of Malaga
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Francisco Javier Barón López
Organizational Affiliation
University of Malaga
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Health Sciences Universidad de Málaga
City
Malaga
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Manuel Pastora-Bernal
Phone
0034658561622
Email
jmpastora@uma.es

12. IPD Sharing Statement

Plan to Share IPD
No
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Effectiveness of Telerehabilitation Program in Subacromial Syndrome (Telerehab Sis)

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