- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03065361
Assessing Manual Components of Brazilian Children and Adolescents on Hemodialysis
Assessing the Handgrip Strength, Fine Motor Skills, and Hand Sensitivity of Brazilian Children and Adolescents on Hemodialysis
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
---|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Jebsen-Taylor Hand Function Test
Tidsramme: 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.
|
30 minutes
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
The Semmes Weinstein Monofilaments Test
Tidsramme: 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.
|
10 minutes
|
Jamar Dynamometer
Tidsramme: 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.
|
15 minutes
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Edinburgh Handedness Inventory
Tidsramme: 15 minutes
|
The handedness setting was defined by the Edinburgh Handedness Inventory,
|
15 minutes
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Thais T Souza, MSc, Federal University of Minas Gerais
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1.305.695
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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