NCT03065361

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 27, 2017

Completed
Last Updated

February 27, 2017

Status Verified

February 1, 2017

Enrollment Period

1.5 years

First QC Date

January 21, 2017

Last Update Submit

February 24, 2017

Conditions

Chronic Kidney Disease

Keywords

Chronic Kidney DiseaseHandgrip StrengthFine Motor SkillsSensitivity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • The Semmes Weinstein Monofilaments Test

    10 minutes

  • Jamar Dynamometer

    15 minutes

Other Outcomes (1)

  • Edinburgh Handedness Inventory

    15 minutes

Study Arms (2)

Group A

Group composed of 21 children and adolescents aged between 9 and 19 years old, treated by hemodialysis in two hospitals of Belo Horizonte. Just in case of some evidence of difference in the results within group A, because of the two types of dialysis (via fistula or catheter), this group can be subdivided in subgroups A1 (n=10) and A2 (n=11), respectively. Group A was already on hemodialysis, the intervention was not performed by the researcher. Our goal was only to evaluate some characteristics of these individuals.

Group B

Group composed of 21 children and adolescents matching age and gender for the Group A participants. The individuals were recruited in schools of Belo Horizonte.

Eligibility Criteria

Age9 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The participants of the group A were not randomized children and adolescents performing hemodialysis treatment in two hospitals of Belo Horizonte. Findings obtained in patients were compared to children and adolescents matched by age and sex, which participants were recruited in schools of Belo Horizonte and metropolitan region part of the group B.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Renal Insufficiency, ChronicHypersensitivity

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsImmune System Diseases

Study Officials

  • Thais T Souza, MSc

    Federal University of Minas Gerais

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

January 21, 2017

First Posted

February 27, 2017

Study Start

August 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

February 27, 2017

Record last verified: 2017-02