Chronic Kidney DiseasesNCT04411927
Impact of Chronic Kidney Disease on Postural Stability in Children
An observational study of Chronic Kidney Diseases, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- assessment of postural stability
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 20 Jan 2020
- 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 8 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
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).
Who may be able to join
- Medically diagnosed with CKD (regardless of medical history),
- Age ranged from eight to fifteen years,
- Both genders
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Chronic Kidney Disease on Postural Stability in Children: A Cross-sectional Observational Study
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.
Read more
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.
Read the detailed description
Methods Study design This study is an observational cross-sectional design (prospective database study).
Participants and setting Participants included children with CKD extracted from a data set of 731 individuals with CKD diagnoses, who receive regular medical follow-up/hemodialysis at Nephrology Unit, Zagazig University Hospitals. The study was conducted from January 2018 to January 2020 in accordance with the Declaration of Helsinki (Code of Ethics of the World Medical Association). The study protocol was approved by the Ethical committee of the Faculty of Physical Therapy, Cairo University, Egypt (No.P.T.REC/012/002169). Children's par-ticipation was authorized by a signed written consent form with parent's/legal guardian's acceptance for participation before starting the study procedures.
Participants 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).
Eligible criteria:
- Medically diagnosed with CKD (regardless of medical history),
- Age ranged from eight to fifteen years,
- Both genders
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. Twenty-five volunteer typically developed age matched group were enrolled as control group.
Basic demographic and clinical information Demographics and physical characteristics (age, sex, weight, height) and clinical data (renal function test, recent hematology and blood chemistry counts, co-morbidity, and medication) were recorded from medical reports to confirm diagnosis.
Study power and sample size Sample size was predestined before conducting the study by G*POWER statistical software (Franz Faul, Universitat Kiel, Germany; version 3.1.9.2) [F tests- ANOVA: Fixed effects, one-way, α=0.05, β=0.2, and large effect size] with the number of groups=3, giving a total number of 66 participants to be recruited in this study.
2.5. Outcome measures The Human Assessment Computer (HUMAC) Balance System, primarily being part of a video game appliance (Wii Balance Board), is a distinct technology used in assessment and rehabilitation of postural control. It is an affordable, portable and prevalent obtainable force plate provides the patient and tester with visual feedback as well as numerical data. The system displays several reporting options with objective datum providing clinicians with comprehensive case progression which is used for baseline and follow-up analysis with eight programs to choose from (HUMAC balance, 2017; Blosch et al., 2019). The HUMAC-type technology has been found to detect more imbalances than traditional tests (Merchant-Borna et al., 2017). In the current study limits of stability, COP and the Clinical Test of Sensory Organization and Balance (CTSIB) were assessed. Each child in the three study groups performed three trials and the mean value was estimated for each test.
2.5.1. Limits of Stability test: Limits of stability are known as the furthest distance a subject is capable to shift his/her COP in different directions whilst keeping the configuration of the BOS and adjust the body position. This commonly requires the use of a force plate that records COP movement and a visual feedback that serves to maximize COP displacement in certain directions (Lemay et al., 2014). During this test, the participant is instructed to shift the round cursor on the screen (the COP) to the highlighted target. As he/she remains in the target for the hold time, this target point is deactivated and should move between the center targets to each surrounding target in a random order. A count-up timer displays the total test time. He/she must return to the center target after each outer target. The test was conducted at two levels 4 and 6. At level 4; this is considered as simple test compared with level 6; the distance between center targets to each surrounding target is relatively small. On the other hand, at level 6 the distance between center targets to each surrounding target is larger.
2.5.2. Center of pressure test This test is used to measure the variation in a subject's COP and displays his/her Right/Left and Anterior/Posterior weight distribution. In the current study, the COP test variables recorded were the stability score and path length.
- Stability test: It measures the participant's ability to stabilize his/her balance at locations around their neutral position. Results are reported as the percent of time a subject holds his COP in each of the eight flashing targets in clockwise order (right/left and anterior/posterior weight distribution). These targets are eight specific points in which the current target flashes green when the participant is on-target and flashes yellow when he is off-target. The HUMAC system provides a counts-down of the hold time to inform the participant when he/she should move to the next target. In addition, the system provides variety of levels based on the distance from the center to the farthest target.
- Path length: The COP path length represents the COP displacement in which lower values indicate better performance (Ju-Hyeong et al., 2020).
2.5.3. Clinical Test of Sensory Organization and Balance: It is sometimes referred as the Romberg or Foam and Dome test. It is used to test how a participant's vestibular, somatosensory and visual systems integrate in the conditions of open and closed eyes compared to a normal population. The CTSIB protocol typically uses four conditions including eyes closed soft surface (ECSS); eyes closed firm surface (ECFS); eyes open soft surface (EOSS); Eye open soft surface (EOSS) and eyes open firm surface (EOFS). The participant was instructed to stand in a neutral position with the arms at body sides. Each participant went through a series of the four tests, which were each 30 seconds long. As participants completed the test, the board monitored their COG to determine their stability and path length. The requirements of the assessment were clearly demonstrated to all children. The assessment procedures were administered following the HUMAC Balance System manual detailed instructions. All participants performed three trials of each test, each lasting 30 seconds to determine the stability score and path length.
- Conditions
- Chronic Kidney Diseases
- Being tested
- assessment of postural stability
- Keywords
- Balance, Chronic kidney disease, HUMAC balance system, Postural stability
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessment of postural stabilityOther
assessment of postural stability
| Study group | Role | What they receive |
|---|---|---|
| control group | this group included 25 typically developed children Receives: Other: assessment of postural stability | |
| on-heamodialysis group | this group included children with CKD on-heamodialysis treatment Receives: Other: assessment of postural stability | |
| non-dialysis group | this group included children with CKD who don't require dialysis Receives: Other: assessment of postural stability |
What is being measured
The primary outcome is the main question the study is designed to answer.
limits of stability test
it was measured by the HUMAC. higher scores indicate good balance
Measured: from January 2018 to January 2020
center of pressure (COP) test
It was measured by the HUMAC balance system. COP is represented by
- path length higher scores indicate poor balance
- stability score with higher results indicate good balance
Measured: 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
Measured: from January 2018 to January 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start1 Jan 2018
- Primary completion20 Jan 2020
- Study completion20 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mahmoud Abd-elmonem, Cairo University
- Investigators
- Nanees E Mohamed, Study chair, Cairo UniversityFaika S Arab, Study director, zagazieg university, EgyptNourhan M Baiomy, Principal investigator, Cairo university, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04411927
- Sponsor's protocol ID
- children with CKD
- Status last verified
- Oct 2022
- First submitted
- 18 May 2020
- Last updated
- 1 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Chronic Kidney Disease on Postural Stability in Children: A Cross-sectional Observational Study
- ClinicalTrials.gov ID
- NCT04411927
- Acronym / sponsor ID
- children with CKD
- Conditions
- Chronic Kidney Diseases
- Keywords
- Balance, Chronic kidney disease, HUMAC balance system, Postural stability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 20 Jan 2020 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 2 Jun 2020 (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.
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.
Detailed description
Methods Study design This study is an observational cross-sectional design (prospective database study).
Participants and setting Participants included children with CKD extracted from a data set of 731 individuals with CKD diagnoses, who receive regular medical follow-up/hemodialysis at Nephrology Unit, Zagazig University Hospitals. The study was conducted from January 2018 to January 2020 in accordance with the Declaration of Helsinki (Code of Ethics of the World Medical Association). The study protocol was approved by the Ethical committee of the Faculty of Physical Therapy, Cairo University, Egypt (No.P.T.REC/012/002169). Children's par-ticipation was authorized by a signed written consent form with parent's/legal guardian's acceptance for participation before starting the study procedures.
Participants 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).
Eligible criteria:
- Medically diagnosed with CKD (regardless of medical history),
- Age ranged from eight to fifteen years,
- Both genders
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. Twenty-five volunteer typically developed age matched group were enrolled as control group.
Basic demographic and clinical information Demographics and physical characteristics (age, sex, weight, height) and clinical data (renal function test, recent hematology and blood chemistry counts, co-morbidity, and medication) were recorded from medical reports to confirm diagnosis.
Study power and sample size Sample size was predestined before conducting the study by G*POWER statistical software (Franz Faul, Universitat Kiel, Germany; version 3.1.9.2) [F tests- ANOVA: Fixed effects, one-way, α=0.05, β=0.2, and large effect size] with the number of groups=3, giving a total number of 66 participants to be recruited in this study.
2.5. Outcome measures The Human Assessment Computer (HUMAC) Balance System, primarily being part of a video game appliance (Wii Balance Board), is a distinct technology used in assessment and rehabilitation of postural control. It is an affordable, portable and prevalent obtainable force plate provides the patient and tester with visual feedback as well as numerical data. The system displays several reporting options with objective datum providing clinicians with comprehensive case progression which is used for baseline and follow-up analysis with eight programs to choose from (HUMAC balance, 2017; Blosch et al., 2019). The HUMAC-type technology has been found to detect more imbalances than traditional tests (Merchant-Borna et al., 2017). In the current study limits of stability, COP and the Clinical Test of Sensory Organization and Balance (CTSIB) were assessed. Each child in the three study groups performed three trials and the mean value was estimated for each test.
2.5.1. Limits of Stability test: Limits of stability are known as the furthest distance a subject is capable to shift his/her COP in different directions whilst keeping the configuration of the BOS and adjust the body position. This commonly requires the use of a force plate that records COP movement and a visual feedback that serves to maximize COP displacement in certain directions (Lemay et al., 2014). During this test, the participant is instructed to shift the round cursor on the screen (the COP) to the highlighted target. As he/she remains in the target for the hold time, this target point is deactivated and should move between the center targets to each surrounding target in a random order. A count-up timer displays the total test time. He/she must return to the center target after each outer target. The test was conducted at two levels 4 and 6. At level 4; this is considered as simple test compared with level 6; the distance between center targets to each surrounding target is relatively small. On the other hand, at level 6 the distance between center targets to each surrounding target is larger.
2.5.2. Center of pressure test This test is used to measure the variation in a subject's COP and displays his/her Right/Left and Anterior/Posterior weight distribution. In the current study, the COP test variables recorded were the stability score and path length.
- Stability test: It measures the participant's ability to stabilize his/her balance at locations around their neutral position. Results are reported as the percent of time a subject holds his COP in each of the eight flashing targets in clockwise order (right/left and anterior/posterior weight distribution). These targets are eight specific points in which the current target flashes green when the participant is on-target and flashes yellow when he is off-target. The HUMAC system provides a counts-down of the hold time to inform the participant when he/she should move to the next target. In addition, the system provides variety of levels based on the distance from the center to the farthest target.
- Path length: The COP path length represents the COP displacement in which lower values indicate better performance (Ju-Hyeong et al., 2020).
2.5.3. Clinical Test of Sensory Organization and Balance: It is sometimes referred as the Romberg or Foam and Dome test. It is used to test how a participant's vestibular, somatosensory and visual systems integrate in the conditions of open and closed eyes compared to a normal population. The CTSIB protocol typically uses four conditions including eyes closed soft surface (ECSS); eyes closed firm surface (ECFS); eyes open soft surface (EOSS); Eye open soft surface (EOSS) and eyes open firm surface (EOFS). The participant was instructed to stand in a neutral position with the arms at body sides. Each participant went through a series of the four tests, which were each 30 seconds long. As participants completed the test, the board monitored their COG to determine their stability and path length. The requirements of the assessment were clearly demonstrated to all children. The assessment procedures were administered following the HUMAC Balance System manual detailed instructions. All participants performed three trials of each test, each lasting 30 seconds to determine the stability score and path length.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | – | Other: assessment of postural stabilitythis group included 25 typically developed children |
| on-heamodialysis group | – | Other: assessment of postural stabilitythis group included children with CKD on-heamodialysis treatment |
| non-dialysis group | – | Other: assessment of postural stabilitythis group included children with CKD who don't require dialysis |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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).
Key inclusion criteria (3 listed)
- Medically diagnosed with CKD (regardless of medical history),
- Age ranged from eight to fifteen years,
- Both genders
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| assessment of postural stabilityassessment of postural stability | Other | control group, non-dialysis group, on-heamodialysis group |
Primary outcome
limits of stability test
Time frame: from January 2018 to January 2020
it was measured by the HUMAC. higher scores indicate good balance
center of pressure (COP) test
Time frame: from January 2018 to January 2020
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
Clinical Test of Sensory Organization and Balance
Time frame: from January 2018 to January 2020
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
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 1 Nov 2022.
- 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.
Nanees E Mohamed study chair
Cairo University
Faika S Arab study director
zagazieg university, Egypt
Nourhan M Baiomy principal investigator
Cairo university, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases, run by Cairo University at 1 site in Egypt.
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 3 inclusion and 5 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 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
limits of stability test (time frame: from January 2018 to January 2020). The study lists 3 primary outcomes in all. 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 1 Nov 2022.