- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03560115
Normative Value of Single Heel-rise Test in School-going Children Along With Its Inter-session Agreement
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.
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.
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Haryana
-
Ambala, Haryana, India, 133207
- Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of heel raise
Time Frame: Upto two weeks
|
Until exhaustion, number of times the heel raise can be achieved by participant
|
Upto two weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rajnee Mishra, BPT, (MPT), Department of Pediatrics and Neonatal Physiotherapy, MMIPR
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MMDU/IEC/1119
- U1111-1214-2525 (Other Identifier: Universal Trial Number (UTN))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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