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Normative Value of Single Heel-rise Test in School-going Children Along With Its Inter-session Agreement

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ClinicalTrials.gov Identifier: NCT03560115
Recruitment Status : Completed
First Posted : June 18, 2018
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Asir John Samuel, Maharishi Markendeswar University

Brief 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. 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.


Condition or disease Intervention/treatment
Healthy Diagnostic Test: Single-heel rise test

Detailed Description:
  1. 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

  2. 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.


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Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Reliability and Normative Value of Single Heel-rise Test in School-going Children
Actual Study Start Date : October 15, 2018
Actual Primary Completion Date : January 10, 2019
Actual Study Completion Date : March 1, 2019

Intervention Details:
  • Diagnostic Test: Single-heel rise test
    Single heel-rise test is used to assess the strength of plantar-flexors clinically


Primary Outcome Measures :
  1. Number of heel raise [ Time Frame: Upto two weeks ]
    Until exhaustion, number of times the heel raise can be achieved by participant



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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • Age group 8-12 years
  • Both boys and girls
  • Healthy school going children

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03560115


Locations
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India
Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation
Ambala, Haryana, India, 133207
Sponsors and Collaborators
Asir John Samuel
Investigators
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Principal Investigator: Rajnee Mishra, BPT, (MPT) Department of Pediatrics and Neonatal Physiotherapy, MMIPR

Additional Information:
Publications of Results:
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Responsible Party: Asir John Samuel, Associate Professor, Maharishi Markendeswar University
ClinicalTrials.gov Identifier: NCT03560115     History of Changes
Other Study ID Numbers: MMDU/IEC/1119
U1111-1214-2525 ( Other Identifier: Universal Trial Number (UTN) )
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It is yet not decided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Asir John Samuel, Maharishi Markendeswar University:
Children
Heel
Reliability
Additional relevant MeSH terms:
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Risedronic Acid
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents