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Completed

NCT Number: NCT03065361

Assessing Manual Components of Brazilian Children and Adolescents on Hemodialysis

The purpose of this study was to assess the handgrip strength; fine motor skills; and hand sensitivity of Brazilian children and adolescents with Chronic Kidney Diseases (CKD). The sample was composed by 42 children and adolescents, 21 on hemodialysis (group A) and the other 21 acted as the control group (group B). The performance of both groups was compared. The outcome measures included Jebsen-Taylor Hand Function Test, the Semmes Weinstein monofilaments test and Jamar Dynamometer.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypersensitivity Immune System Diseases Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

9 year–19 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Clinical diagnosis of CKD with active hemodialysis treatment (only to group A);
  • Ability to understand the tests and questionnaires applied.

Exclusion criteria

  • Neuropsychiatric disease associated; and
  • Any medical contraindication against the participation in the study.

Treatment and study plan

Primary outcomes

  1. Jebsen-Taylor Hand Function Test

    Time frame: 30 minutes

    The manual functioning of upper limbs were assessed by the Jebsen-Taylor Hand Function Test, a standardized test composed by manual tasks based on daily activities. The test is divided into seven sub-tests: (1) writing, (2) flipping cards, (3) small objects lifting, (4) spoon usage, (5) blocks stacking, (6) large and lightweight objects lifting, and (7) large and heavy objects lifting.

Secondary outcomes

  1. The Semmes Weinstein Monofilaments Test

    Time frame: 10 minutes

    The Semmes Weinstein monofilaments test was used to evaluate the skin threshold sensitivity. In this test, the damage to the skin sensitivity is classified in colors. The eyes are blindfolded and the nylon monofilaments are applied to the hands of participants until the touch is felt in the dermatomes, regarding the distribution of the ulnar, median and radial.

  2. Jamar Dynamometer

    Time frame: 15 minutes

    The handgrip strength was checked by the Jamar® Dynamometer, it is constituted by a voltage sealers system which indicates on the device the handgrip strength in kilograms/strength (kg/f) or in pounds/inch. The device was used three times before and after hemodialysis session, and the results were based on the average of the three applications. In the group B, the test was applied 3 times, and obtained average. The dynamometer works in many situations in order to determine the functionality of the hands and is considered a "gold standard" for this purpose.

Other outcomes

  1. Edinburgh Handedness Inventory

    Time frame: 15 minutes

    The handedness setting was defined by the Edinburgh Handedness Inventory,

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Registry information

Official study title

Assessing the Handgrip Strength, Fine Motor Skills, and Hand Sensitivity of Brazilian Children and Adolescents on Hemodialysis

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 27, 2017
Registry last updated
Feb 27, 2017

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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