HealthyNCT03560115
Normative Value of Single Heel-rise Test in School-going Children Along With Its Inter-session Agreement
An observational study of Healthy, run by Asir John Samuel at 1 site in India.
Trial summary
Background: Single heel-rise test (SHRT) is a method of assessing the strength and endurance of plantar-flexors manually. Single heel-rise test also known as calf rise test, is a method of assessing the strength of plantar-flexor. The test was first done to determine the integrity of calf muscle. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Single-heel rise test
- How many people
- 500 participants
- Where
- 1 siteIndia
- Study dates
- 15 Oct 2018to 1 Mar 2019
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study will be conducted on healthy children of 8-12 years age group. Any condition that can limit the test measure will be excluded as the test is aimed to achieve normative value.
Who may be able to join
- Age group 8-12 years
- Both boys and girls
- Healthy school going children
Who cannot join
- Un co-operative children
- Children with recent history of injury or surgery in past 6 months
- Any condition that can limit the test outcome (Pain, weakness, etc)
Trial locations and contacts
1 site in 1 country.
India1 site
Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation
Ambāla, Haryana, 133207
About this study
Official title: Reliability and Normative Value of Single Heel-rise Test in School-going Children
Background:
Single heel-rise test (SHRT) is a method of assessing the strength and endurance of plantar-flexors manually. Single heel-rise test also known as calf rise test, is a method of assessing the strength of plantar-flexor. The test was first done to determine the integrity of calf muscle. There are few studies which has established the reliability and normative value of heel-rise test in adults. But till date, there is no documented evidence of normative value of heel-rise test in children.
Read more
Aim:
The study is focused to derive reliability and normative value of single heel-rise test in children of age group 8-12 years.
Methods:
The study will recruit healthy school-going children of 8-12 years age. Any pathology which can limit or interfere with the test outcome will be excluded. The samples will be collected by stratified sampling technique. Procedure of test will be demonstrated prior to the test. Heel raising and lowering will be performed until child feels fatigue. Test will be performed on both the lower extremities individually.
Data analysis:
Test will be assessed on both the heel individually. Three sessions will be conducted by the same rater on same child for intra-rater and test-retest reliability, and another rater will assess the test on same individual for establishing inter-rater reliability. Normative value of the test will be determined by deriving the mean of test-values for each age group.
Read the detailed description
- Introduction: Plantar flexors play a crucial role in gait cycle, during foot clearance. It assists in forward propulsion, and is also responsible for maintaining the static and dynamic balances. Single heel-rise test is a physical examination which evaluates the strength of plantar-flexors. This study aims to assess the intra-rater and inter-rater reliability and normative value of single heel-rise test in healthy school-going children of age group 8-12 years. 1.1.Problem Statement: The documented evidences does not have normative value for single heel-rise test in children. The normative value is provided only for adults. Therefore, there is an absolute need of deriving normative value for this test in children. 1.2.Purpose of the study: The purpose of this study is to derive the normative value of single-heel rise test along with reliability. 1.3.Objectives of the study: 1.3.1.To establish inter-rater and intra-rater and test-retest reliability of single heel-rise test 1.3.2.To derive normative value of single heel-rise test
- Procedure:
The study will be a cross-sectional study. The study protocol has been approved from the Institutional Ethics Committee of Maharishi Markandeshwar (Deemed to be University).
All the anthropometrics of the children will be taken prior to the test which includes height, weight, calf muscle girth and length. The maximum number of heel-rises will be performed by the child in single limb stance until maximal exertion will be recorded. The test will be repeated in standing position on both the sides. For balancing, 2-finger support on wall will be allowed.
Reliability testing: For inter-rater, 2 raters will assess on two different sessions on same day. For intra-rater, same rater will assess the test twice on same day, and after 24 hours for test-retest reliability.
Normative value: The mean of all the test-values for each age group will be normative value for that particular age group.
- Conditions
- Healthy
- Being tested
- Single-heel rise test
- Keywords
- Children, Heel, Reliability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-heel rise testDiagnostic test
Single heel-rise test is used to assess the strength of plantar-flexors clinically
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of heel raise
Until exhaustion, number of times the heel raise can be achieved by participant
Measured: Upto two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start15 Oct 2018
- Primary completion10 Jan 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asir John Samuel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Asir John Samuel, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- Rajnee Mishra, BPT, (MPT), Principal investigator, Department of Pediatrics and Neonatal Physiotherapy, MMIPR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03560115
- Sponsor's protocol ID
- MMDU/IEC/1119
- Other IDs
- U1111-1214-2525
- Status last verified
- Mar 2019
- First submitted
- 18 May 2018
- Last updated
- 19 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is yet not decided
Publications
Monteiro DP, Britto RR, Fregonezi GAF, Dias FAL, Silva MGD, Pereira DAG. Reference values for the bilateral heel-rise test. Braz J Phys Ther. 2017 Sep-Oct;21(5):344-349. doi: 10.1016/j.bjpt.2017.06.002. Epub 2017 Jul 3.
PubMed 28709587
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Normative Value of Single Heel-rise Test in School-going Children
- ClinicalTrials.gov ID
- NCT03560115
- Acronym / sponsor ID
- MMDU/IEC/1119
- Conditions
- Healthy
- Keywords
- Children, Heel, Reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Asir John SamuelUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 10 Jan 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 18 Jun 2018 (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:
Single heel-rise test (SHRT) is a method of assessing the strength and endurance of plantar-flexors manually. Single heel-rise test also known as calf rise test, is a method of assessing the strength of plantar-flexor. The test was first done to determine the integrity of calf muscle. There are few studies which has established the reliability and normative value of heel-rise test in adults. But till date, there is no documented evidence of normative value of heel-rise test in children.
Aim:
The study is focused to derive reliability and normative value of single heel-rise test in children of age group 8-12 years.
Methods:
The study will recruit healthy school-going children of 8-12 years age. Any pathology which can limit or interfere with the test outcome will be excluded. The samples will be collected by stratified sampling technique. Procedure of test will be demonstrated prior to the test. Heel raising and lowering will be performed until child feels fatigue. Test will be performed on both the lower extremities individually.
Data analysis:
Test will be assessed on both the heel individually. Three sessions will be conducted by the same rater on same child for intra-rater and test-retest reliability, and another rater will assess the test on same individual for establishing inter-rater reliability. Normative value of the test will be determined by deriving the mean of test-values for each age group.
Detailed description
- Introduction: Plantar flexors play a crucial role in gait cycle, during foot clearance. It assists in forward propulsion, and is also responsible for maintaining the static and dynamic balances. Single heel-rise test is a physical examination which evaluates the strength of plantar-flexors. This study aims to assess the intra-rater and inter-rater reliability and normative value of single heel-rise test in healthy school-going children of age group 8-12 years. 1.1.Problem Statement: The documented evidences does not have normative value for single heel-rise test in children. The normative value is provided only for adults. Therefore, there is an absolute need of deriving normative value for this test in children. 1.2.Purpose of the study: The purpose of this study is to derive the normative value of single-heel rise test along with reliability. 1.3.Objectives of the study: 1.3.1.To establish inter-rater and intra-rater and test-retest reliability of single heel-rise test 1.3.2.To derive normative value of single heel-rise test
- Procedure:
The study will be a cross-sectional study. The study protocol has been approved from the Institutional Ethics Committee of Maharishi Markandeshwar (Deemed to be University).
All the anthropometrics of the children will be taken prior to the test which includes height, weight, calf muscle girth and length. The maximum number of heel-rises will be performed by the child in single limb stance until maximal exertion will be recorded. The test will be repeated in standing position on both the sides. For balancing, 2-finger support on wall will be allowed.
Reliability testing: For inter-rater, 2 raters will assess on two different sessions on same day. For intra-rater, same rater will assess the test twice on same day, and after 24 hours for test-retest reliability.
Normative value: The mean of all the test-values for each age group will be normative value for that particular age group.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study will be conducted on healthy children of 8-12 years age group. Any condition that can limit the test measure will be excluded as the test is aimed to achieve normative value.
Key inclusion criteria (3 listed)
- Age group 8-12 years
- Both boys and girls
- Healthy school going children
Key exclusion criteria (3 listed)
- Un co-operative children
- Children with recent history of injury or surgery in past 6 months
- Any condition that can limit the test outcome (Pain, weakness, etc)
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 |
|---|---|---|
| Single-heel rise testSingle heel-rise test is used to assess the strength of plantar-flexors clinically | Diagnostic test | – |
Primary outcome
Number of heel raise
Time frame: Upto two weeks
Until exhaustion, number of times the heel raise can be achieved by participant
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 19 Mar 2019.
- Results publication: PubMed 28709587Monteiro DP, Britto RR, Fregonezi GAF, Dias FAL, Silva MGD, Pereira DAG. Reference values for the bilateral heel-rise test. Braz J Phys Ther. 2017 Sep-Oct;21(5):344-349. doi: 10.1016/j.bjpt.2017.06.002. Epub 2017 Jul 3.
- Reference values for the bilateral heel-rise testLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. It is yet not decided
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Rajnee Mishra, BPT, (MPT) principal investigator
Department of Pediatrics and Neonatal Physiotherapy, MMIPR
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 Healthy, run by Asir John Samuel at 1 site in India.
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 3 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 19 Mar 2019. 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 India. 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?
Number of heel raise (time frame: Upto two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03560115, which also lists 1 linked publication.
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 19 Mar 2019.