Effect of Video-Assisted Training on Upper Extremity Problems and Functions in Patients Undergoing Rotator Cuff Repair

May 5, 2020 updated by: Gulay ALTUN UGRAS, Mersin University

The Effect of Video-Assisted Training on Upper Extremity Problems and Functions in Patients Undergoing Rotator Cuff Repair: A Randomized Controlled Trial

This randomized controlled trial evaluates the effect of video-assisted training (VAT) on upper extremity problems and functions in rotator cuff repair (RCR) patients. The hypothesis of this study is that VAT decreases upper extremity problems and increases functions after RCR.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Methods: Forty-eight elective RCR patients were randomly assigned to VAT and control groups. VAT group (n=24) received VAT including early post-operative care for RCR, activities of daily living (ADL) and gradual exercise program while control group (n=24) received routine care. Primary outcomes were upper extremity problems and functions, assessed using Disabilities of the Arm, Shoulder and Hand (DASH) and Modified Constant-Murley (MCM) scores. Secondary outcomes were complications within three months. Outcomes were collected at baseline, after six weeks and three months.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Yenisehir
      • Mersin, Yenisehir, Turkey, 33343
        • Mersin University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: Patients who

  • underwent elective RCR for the first time;
  • whose arm was suspended and fixed for up to three weeks after RCR;
  • had an SMMT score of ≥23 points;

Exclusion Criteria: Patients who

  • had been diagnosed with a psychiatric illness;
  • have any history of an upper extremity fracture or a rheumatologic disease;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Video-Assisted Training Group
The patients in the VAT group watch a training video in the patient rooms before RCR in addition to the routine treatment and care in the unit.
The patients in the VAT group watch a training video in the patient rooms before RCR. The VAT prepared by the researchers consisted of information about things to pay attention to in the hospital in the early period after RCR (nursing care on post-operative day 1, early mobilization, pain control, shoulder protection, and wearing/removing the shoulder sling), maintaining ADL at home (bathing, nutrition, eating, sleeping position, driving, doing household chores, sexual life, worship, and safety measures to be taken at home) and gradual exercise programs (for the first 90 days after discharge).
Other Names:
  • Control group
No Intervention: control group
The control group received the routine treatment and care in the unit. The routine treatment and care of the unit includes verbal briefing by physicians and nurses about the surgical procedure before RCR, cold application and analgesic application for pain control after RCR, using arm sling, verbal discharge training (e.g., drug use, exercises, follow-up time, etc.) and discharge on the first post-operative day in the absence of complications. In addition, patients are invited to weekly controls to explain how to do the exercises and, if necessary, they are referred to physiotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change upper extremity problems
Time Frame: Change from baseline the Disabilities of the Arm, Shoulder and Hand score at 3 months
The patients' upper extremity problems were assessed using the Disabilities of the Arm, Shoulder and Hand. The possible scores on each part of the questionnaire range from 0 to 100, with higher scores indicating a higher disability level of patients (0=no disability, 100=maximum disability)
Change from baseline the Disabilities of the Arm, Shoulder and Hand score at 3 months
Change upper extremity functions
Time Frame: Change from baseline the Modified Constant-Murley score at 3 months
The patients' upper extremity functions were assessed using the Modified Constant-Murley score. The Modified Constant-Murley score consists of 100 points in total: 15 points for pain, 20 points for daily of living activities, 40 points for movement and 25 points for strength. The maximum MCM score is 100 points, with higher scores indicating better shoulder functions
Change from baseline the Modified Constant-Murley score at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of complications
Time Frame: 1st and 3rd months
Determine complications after rotator cuff repair
1st and 3rd months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Gülay Altun Ugras, PhD, Mersin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

November 28, 2018

Study Completion (Actual)

November 28, 2018

Study Registration Dates

First Submitted

April 29, 2020

First Submitted That Met QC Criteria

April 30, 2020

First Posted (Actual)

May 5, 2020

Study Record Updates

Last Update Posted (Actual)

May 7, 2020

Last Update Submitted That Met QC Criteria

May 5, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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