NCT04411927

Brief Summary

Background: Chronic kidney disease is associated with comorbid conditions that result in physical impairments. Objectives: Investigate the impact of chronic kidney disease (CKD) on postural stability in children compared with age matched typically developing children using Human Assessment Computer (HUMAC) balance system. Design: An observational design (cross-sectional study). Settings: The assessment procedures were conducted at the Nephrology Unit, Zagazig University Hospitals. Participants: Seventy-five children, age ranged from 8 to 15 years represented three groups of equal numbers; control group (typically developed), non-dialysis (stage 3 and 4) and hemodialysis group. Outcome measures: The HUMAC balance system was used to assess the limits of stability, center of pressure and sensory organization and balance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

January 1, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 2, 2020

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

2.1 years

First QC Date

May 18, 2020

Last Update Submit

October 31, 2022

Conditions

Keywords

BalanceChronic kidney diseaseHUMAC balance systemPostural stability

Outcome Measures

Primary Outcomes (3)

  • limits of stability test

    it was measured by the HUMAC. higher scores indicate good balance

    from January 2018 to January 2020

  • center of pressure (COP) test

    It was measured by the HUMAC balance system. COP is represented by 1. path length higher scores indicate poor balance 2. stability score with higher results indicate good balance

    from January 2018 to January 2020

  • Clinical Test of Sensory Organization and Balance

    it was measured by the HUMAc balance system to represent the ability of the child to keep balance while standing on firm and solid surfaces alternatively with eyes open and then eyes closed

    from January 2018 to January 2020

Study Arms (3)

control group

this group included 25 typically developed children

Other: assessment of postural stability

on-heamodialysis group

this group included children with CKD on-heamodialysis treatment

Other: assessment of postural stability

non-dialysis group

this group included children with CKD who don't require dialysis

Other: assessment of postural stability

Interventions

assessment of postural stability

control groupnon-dialysis groupon-heamodialysis group

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Fifty eligible volunteer children with CKD were recruited from Nephrology Unit, Zagazig University Hospitals to be enrolled in this study and allocated into either hemodialysis (on hemodialysis) or non-dialysis group (children at stage 3 and 4).

You may qualify if:

  • Medically diagnosed with CKD (regardless of medical history),
  • Age ranged from eight to fifteen years,
  • Both genders

You may not qualify if:

  • Participants were excluded if they had:
  • Communication problems such as intellectual disability, autism, Down syndrome, or cerebral palsy,
  • Significant visual or hearing problems,
  • Any neurological and/or musculoskeletal disorders which influence postural stability,
  • Chronic cardiovascular or pulmonary disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of physical therapy, Cairo university

Giza, 12662, Egypt

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

  • Nanees E Mohamed

    Cairo University

    STUDY CHAIR
  • Faika S Arab

    zagazieg university, Egypt

    STUDY DIRECTOR
  • Nourhan M Baiomy

    Cairo university, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Amira Abd-elmonem, assist Prof. Physiacl therapy for pediatric department, faculty of physical therapy , Cairo university

Study Record Dates

First Submitted

May 18, 2020

First Posted

June 2, 2020

Study Start

January 1, 2018

Primary Completion

January 20, 2020

Study Completion

January 20, 2020

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations