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OpenTrials
Completed

NCT Number: NCT02321059

Validation of the Goodstrength System for Assessment of Abdominal Wall Strength in Patients With Incisional Hernia

Patients with an incisional hernia in the midline and controls with an intact abdominal wall are examined twice with one week apart, in order to establish the test-retest reliability and internal and external validity of the Goodstrength trunk dynamometer.

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Key information

Conditions

Incisional Hernia Behavior Hernia Motor Activity Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bispebjerg Hospital

Copenhagen NV, Copenhagen, 2400, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • American Society of Anesthesiologists score 1-3
  • Age equal to or above 18
  • Ventral incisional hernia OR intact abdominal wall

Exclusion criteria

  • Pregnancy
  • Severe heart disease (New York Heart Association class III-IV)
  • Severe pulmonary disease
  • Severe musculoskeletal disease
  • Systemic treatment with glucocorticoid

Treatment and study plan

Measurement of abdominal wall strength

Device

Test-retest examination of the reliability of the Goodstrength trunk dynamometer

Primary outcomes

  1. Abdominal wall strength measured by the Goodstrength system

    Time frame: One week

    Change in abdominal wall strength from baseline to follow-up.

Secondary outcomes

  1. Physical activity the last week, assessed by the International Physical Activity Questionnaire

    Time frame: Once, at baseline examination

  2. Self-assessed abdominal wall strength, as measured on a visual analogue scale

    Time frame: Once, at baseline examination

  3. Trunk extensor strength measured by the Goodstrength system

    Time frame: One week

    Change in trunk extensor strength from baseline to follow-up.

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Acronym: VAGSI

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 22, 2014
Registry last updated
Jun 26, 2015

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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