Assessing Manual Components of Brazilian Children and Adolescents on Hemodialysis

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03065361
• Other study ID #: 1.305.695
• Status: Completed
• Phase: N/A
• First received: January 21, 2017
• Last updated: February 24, 2017
• Start date: August 2014
• Est. completion date: February 2016

Study information

• Verified date: February 2017
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Edinburgh Handedness Inventory	The handedness setting was defined by the Edinburgh Handedness Inventory,	15 minutes
Primary	Jebsen-Taylor Hand Function Test	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.	30 minutes
Secondary	The Semmes Weinstein Monofilaments Test	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.	10 minutes
Secondary	Jamar Dynamometer	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.	15 minutes