Chronic Kidney DiseaseNCT03065361
Assessing Manual Components of Brazilian Children and Adolescents on Hemodialysis
An observational study of Chronic Kidney Disease, run by Federal University of Minas Gerais.
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). Read more about this study
- Who is it for?
- Ages 9 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- Clinical diagnosis of CKD with active hemodialysis treatment (only to group A);
- Ability to understand the tests and questionnaires applied.
Who cannot join
- Neuropsychiatric disease associated; and
- Any medical contraindication against the participation in the study.
About this study
Official title: Assessing the Handgrip Strength, Fine Motor Skills, and Hand Sensitivity 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.
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic Kidney Disease, Handgrip Strength, Fine Motor Skills, Sensitivity
- Medical subject headings
- Renal Insufficiency, Chronic, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes
Secondary outcomes (2)
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.
Measured: 10 minutes
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.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study startAug 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thais Thaler Souza, Federal University of Minas Gerais
- Investigators
- Thais T Souza, MSc, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03065361
- Sponsor's protocol ID
- 1.305.695
- Status last verified
- Feb 2017
- First submitted
- 21 Jan 2017
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Handgrip Strength, Fine Motor Skills, and Hand Sensitivity of Brazilian Children and Adolescents on Hemodialysis
- ClinicalTrials.gov ID
- NCT03065361
- Acronym / sponsor ID
- 1.305.695
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic Kidney Disease, Handgrip Strength, Fine Motor Skills, Sensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 27 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 9 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- Clinical diagnosis of CKD with active hemodialysis treatment (only to group A);
- Ability to understand the tests and questionnaires applied.
Key exclusion criteria (2 listed)
- Neuropsychiatric disease associated; and
- Any medical contraindication against the participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
The Semmes Weinstein Monofilaments Test
Time frame: 10 minutes
Jamar Dynamometer
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thais T Souza, MSc principal investigator
Federal University of Minas Gerais
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by Federal University of Minas Gerais.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Jebsen-Taylor Hand Function Test (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2017.