- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04374331
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:
|
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.
Sponsor
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
Keywords
Other Study ID Numbers
- Gulay Altun
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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