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

NCT04374331 | Completed

• 1 other identifier: Gulay Altun
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rotator Cuff Repair

Keywords

Rotator cuff repair; video-assisted training; upper extremity problems; upper extremity functions; complication

Outcome Measures

Primary Outcomes (2)

• Change upper extremity problems

  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

  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 Outcomes (1)

• Change of complications

  1st and 3rd months

Study Arms (2)

Video-Assisted Training Group

EXPERIMENTAL

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.

Other: video-assisted training

control group

NO INTERVENTION

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.

Interventions

video-assisted training OTHER

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).

Also known as: Control group

Video-Assisted Training Group

Eligibility Criteria

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

You may qualify if:

• 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;

You may not qualify if:

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

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin University

Mersin, Yenisehir, 33343, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Gulay Altun Ugras, PhD

  Mersin University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Before inclusion, the patients were informed about the duration of care as usual, which could be six weeks or three months. The patients were blinded to the group assignment due to the nature of the intervention. The researchers involved in the data analysis and statistics stages were blinded to the group assignment, too. However, those involved in the running of the study were not blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: prospective, parallel, two arm, randomized controlled clinical trial

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 5, 2020
• Study Start: September 1, 2017
• Primary Completion: November 28, 2018
• Study Completion: November 28, 2018
• Last Updated: May 7, 2020

Record last verified: 2020-05

Locations

TU (1)