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

NCT ID: NCT04374331

Last Updated: 2020-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2018-11-28

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.

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.

Conditions

Rotator Cuff Repair

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

video-assisted training

Intervention Type: 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).

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

video-assisted training

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).

Intervention Type: OTHER

Other Intervention Names

Control group

Eligibility Criteria

Inclusion Criteria

• 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mersin University

OTHER

Sponsor Role: lead

Responsible Party

Gulay ALTUN UGRAS

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gulay Altun Ugras, PhD

Role: STUDY_DIRECTOR

Mersin University

Locations

Mersin University

Mersin, Yenisehir, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Gulay Altun

Identifier Type: -

Identifier Source: org_study_id