Effectiveness of Telerehabilitation Program in Subacromial Syndrome (Telerehab Sis)

NCT02909920 | Unknown

• 1 other identifier: 0761-M1-16
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Impingement Syndrome

Keywords

Telerehabilitation; Physiotherapy; Surgery; Telemedicine

Outcome Measures

Primary Outcomes (1)

• 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.

  Initial, 4 weeks, 8 weeks and 12 weeks

Secondary Outcomes (1)

• Changes in Constant Shoulder test Score

  Initial, 4 weeks, 8 weeks and 12 weeks

Other Outcomes (2)

• Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ) (Spanish adaptation)

  12 weeks

• Direct and Indirect Costs

  12 weeks

Study Arms (2)

Telerehabilitation

EXPERIMENTAL

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

Traditional Physiotherapy

ACTIVE COMPARATOR

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

Interventions

Telerehabilitation OTHER

Initial Videoconference following telerehabilitation programs self-workout exercise with video support.

Telerehabilitation

Traditional Physiotherapy 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).

Traditional Physiotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jose Manuel Pastora Bernal: lead
• University of Malaga: collaborator
• Hospital Costa del Sol: collaborator

Study Sites (1)

Faculty of Health Sciences Universidad de Málaga

Málaga, Malaga, Spain

RECRUITING

Related Publications (68)

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  PMID: 28231815 DERIVED

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Jose Manuel Pastora Bernal

  University of Malaga

  PRINCIPAL INVESTIGATOR

• Rocio Martín Valero

  University of Malaga

  STUDY DIRECTOR

• Francisco Javier Barón López

  University of Malaga

  STUDY DIRECTOR

Central Study Contacts

Jose Manuel Pastora Bernal

CONTACT

0034 658561622; jmpastora@uma.es

Jose Manuel Pastora Bernal

CONTACT

0034 658561622; jospasber@uma.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MSc Research in Health Sciences (Phd Health Sciences Student)

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: September 21, 2016
• Study Start: September 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: May 1, 2017
• Last Updated: October 11, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)