CClinicalTrials.gg
Status unknownNCT02909920telerehabUpdated Oct 11, 2016

Effectiveness of Telerehabilitation Program in Subacromial Syndrome (Telerehab Sis)

An interventional study of Telerehabilitation and Traditional Physiotherapy in Shoulder Impingement Syndrome, sponsored by Jose Manuel Pastora Bernal. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-10-11.

Sponsored by Jose Manuel Pastora Bernal · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
138
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Shoulder Impingement Syndrome

Keywords

  • Telerehabilitation
  • Physiotherapy
  • Surgery
  • Telemedicine
03

In context

Shoulder Impingement Syndrome

304 studies on the registry are indexed under Shoulder Impingement Syndrome; 55 are open to participants now.

This study's planned enrollment of 138 is above the median of 54 across 261 interventional studies indexed under Shoulder Impingement Syndrome.

Browse Shoulder Impingement Syndrome studies →

Lead sponsor

This is the only study on the registry with Jose Manuel Pastora Bernal as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
138 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • OtherTelerehabilitation

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

  • OtherTraditional 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).

06

What researchers measure

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.

    Time frame: Initial, 4 weeks, 8 weeks and 12 weeks

Secondary outcomes

  1. 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.

    Time frame: Initial, 4 weeks, 8 weeks and 12 weeks

Other outcomes

  1. Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ) (Spanish adaptation)

    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

  2. Direct and Indirect Costs

    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

07

Study locations

1 of 1 sites recruiting
  • Faculty of Health Sciences Universidad de Málaga
    Malaga, Spain
    Recruiting
08

References and documents

Publications

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Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02909920
Lead sponsor
Jose Manuel Pastora Bernal
Collaborators
University of Malaga, Hospital Costa del Sol
Responsible party
Jose Manuel Pastora Bernal (MSc Research in Health Sciences (Phd Health Sciences Student), University of Malaga) — Sponsor-investigator
First posted
Sep 21, 2016
Start date
Sep 2016
Primary completion
Mar 2017 (estimated)
Completion
May 2017 (estimated)
Last update
Oct 11, 2016

Study contacts

Jose Manuel Pastora Bernal
Contact
jmpastora@uma.es
0034 658561622
Jose Manuel Pastora Bernal
Contact
jospasber@uma.es
0034 658561622
Jose Manuel Pastora Bernal
principal investigator · University of Malaga
Rocio Martín Valero
study director · University of Malaga
Francisco Javier Barón López
study director · University of Malaga

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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