Clinical trial NCT03560115: Normative Value of Single Heel-rise Test in School-going Children Along With Its Inter-session Agreement
Official title: Reliability and Normative Value of Single Heel-rise Test in School-going Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Children
Heel
Reliability
Lead sponsor: Maharishi Markendeswar University (Deemed to be University)
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 500
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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)

Primary outcomes:
measure: Number of heel raise
timeFrame: Upto two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ambala
country: India
facility: Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation
state: Haryana
Study officials:
affiliation: Department of Pediatrics and Neonatal Physiotherapy, MMIPR
name: Rajnee Mishra, BPT, (MPT)
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.