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Completed

NCT Number: NCT03539211

Clinical Assessment and Thickness Changes of the Oblique and Multifidus Muscles

This study evaluates the effect of a rotation based exercise program on core muscle thickness. Additionally, a second aim is to demonstrate the ability of a clinical assessment tool to identify muscle thickness changes. Half of participants receive the rotation based exercises, while the other half perform a traditional core exercise program. It was hypothesized that the rotation based exercises would result in greater changes in muscle thickness.

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Key information

Conditions

Abdominal Muscles

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Delaware

Newark, Delaware, 19702, United States

About this study

A number of exercise programs and assessment tools have been evaluated for their ability to influence and measure the core muscles. Inefficient stability and asymmetrical muscle activity of the core have been linked to a wide range of lower extremity injuries. Training of the abdominal muscles to obtain symmetrical recruitment for optimal trunk stabilization is a widespread clinical practice, however valid and reliable assessment tools and effective intervention protocols are lacking. This study uniquely uses both a clinical assessment tool and musculoskeletal ultrasound to measure changes in the core muscles following an exercise intervention. The overall purpose of this study was to design a valid and reliable assessment tool and an effective training protocol to activate the core muscles.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

° Undergraduate and graduate subjects from the University of the Delaware student community.

Exclusion criteria

  • You could be excluded if you have recently undergone surgery in the last 6 months.
  • Currently suffering from low back pain.
  • Or have a history of a neurological condition.

Treatment and study plan

Rotation Exercises

Other

The subjects received 7 trunk rotation stability exercises x 10 reps each

Other names: Sling Activation Session

Control Exercises

Other

The subjects received 7 traditional exercises x 10 reps each

Other names: Traditional

Primary outcomes

  1. Changes in Muscle Thickness

    Time frame: Baseline and 10 minutes post intervention

    Musculoskeletal ultrasound measured changes in muscle thickness

Secondary outcomes

  1. Changes in Clinical Muscle Assessment Using the Novel Sling Screen

    Time frame: Baseline and 10 minutes post intervention

    Clinician based assessment of muscle function using the sling screen tool; Kappa coefficients were calculated to examine agreement between the 2 physical therapists that completed the sling screen assessments and to account for chance effects in scoring.

    A rating system was used for scoring performance. Min value on the scale is 2 and max value = 5; higher score is a better outcome.

Sponsors and collaborators

Lead sponsor

Christiana Care Health Services

Other

Registry information

Official study title

Clinical Assessment and Thickness Changes of the Oblique and Multifidus Muscles Using a Novel Screening Tool and Exercise Program: A Randomized Controlled Trial

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 29, 2018
Registry last updated
Sep 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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