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Completed

NCT Number: NCT04374331

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mersin University

Mersin, Yenisehir, 33343, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

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).

Other names: Control group

Primary outcomes

  1. 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)

  2. 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

Secondary outcomes

  1. Change of complications

    Time frame: 1st and 3rd months

    Determine complications after rotator cuff repair

Sponsors and collaborators

Lead sponsor

Mersin University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 5, 2020
Registry last updated
May 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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