NCT03560115

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 18, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

October 15, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

March 19, 2019

Status Verified

March 1, 2019

Enrollment Period

3 months

First QC Date

May 18, 2018

Last Update Submit

March 17, 2019

Conditions

Keywords

ChildrenHeelReliability

Outcome Measures

Primary Outcomes (1)

  • Number of heel raise

    Until exhaustion, number of times the heel raise can be achieved by participant

    Upto two weeks

Interventions

Single-heel rise testDIAGNOSTIC_TEST

Single heel-rise test is used to assess the strength of plantar-flexors clinically

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation

Ambāla, Haryana, 133207, India

Location

Related Publications (1)

  • 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.

Related Links

Study Officials

  • Rajnee Mishra, BPT, (MPT)

    Department of Pediatrics and Neonatal Physiotherapy, MMIPR

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 18, 2018

First Posted

June 18, 2018

Study Start

October 15, 2018

Primary Completion

January 10, 2019

Study Completion

March 1, 2019

Last Updated

March 19, 2019

Record last verified: 2019-03

Locations