Viewing Study NCT02909920


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Study NCT ID: NCT02909920
Status: UNKNOWN
Last Update Posted: 2016-10-11
First Post: 2016-09-14
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Effectiveness of Telerehabilitation Program in Subacromial Syndrome (Telerehab Sis)
Sponsor: Jose Manuel Pastora Bernal
Organization:

Study Overview

Official Title: Effectiveness of Telerehabilitation Program Following Surgery Procedures in Subacromial Syndrome Compared With Traditional Therapy. A Randomized Clinical Trial (Telerehab)
Status: UNKNOWN
Status Verified Date: 2016-10
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: telerehab
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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: