Estimating Error in Locating Touch Sensation on Forearm in Healthy Middle School Going Children

April 5, 2019 updated by: Asir John Samuel, Maharishi Markendeswar University (Deemed to be University)

Standard References Norms for Tactile Localization Acuity in Upper Limb Among the Asymptomatic Middle School Children: A Normative Research

Tactile localization stimuli are fundamental in forearm to the somatosensory perception.Tactile localization reverse the touch internal organization of the forearm and in the normal development of children.It is helpful in quick estimation of tactile localization among the children in the age group, eight to thirteen years.Study design is cross-sectional study it is conducted from September 2017 to April 2019 and use stratified random sampling. subject recruitment is healthy school going children of age group between eight and thirteen year will be included in this study.The procedure will be explained to the children's before starting the test. Ascent will be obtained from the participant. Anthropometrics will be measured before beginning the procedure. The acuity of TL will be determined by the point-to-point tactile localization (PPTL) technique. For performing PPTL, the child will be seated and the examiner will locate a point on the participants forearm of the blinded child by a black pen marker. Then the child will be asked to relocate the point with the help of red pen marker in blindfolded state. The distance between black point and red point (in cm) will be noted this distance will be measure by measuring tape as the acuity of tactile localization. Mean of three readings will be used for estimating the normative reference value of tactile localization by PPTL technique.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

For performing Point to Point Tactile Localization, the child will be seated and the examiner will locate a point on the forearm of the blinded child by a black marker pen. Then the child will be asked to relocate the point with the help of red marked in blindfolded state. The distance between black point and red point (in cm) will be noted as the acuity of tactile localization. 15 areas in upper limb will be selected and PPTL will be performed on them. The fifteen areas are, phalanges of the palmer area of the little finger (palm 1), phalanx of the middle finger of the Palmer area (palm 2), phalanx of the thumb area of palm (palm 3), first dorsal interosseous (palm 4), mid last part of the forearm (forearm 1), middle of the medial forearm (forearm 2), medial side of the forearm (forearm 3), the lower portion of the arm (arm 1), middle posterior of arm (arm 2), lateral side of upper arm (arm 3), lower portion of medial arm (arm 4), middle portion of arm (arm 5), the median upper arm (arm 6), lower side arm (arm 7), and upper side of arm (arm 8). Mean of three readings will be used for estimating the normative reference value of tactile localization by PPTL technique.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
365

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Haryana
      • Ambala, Haryana, India, 133207
        • Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation
      • Ambala, Haryana, India, 133207
        • Asir John Samuel

Participation Criteria

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Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 13 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Healthy school going children age between eight and thirteen years without any neurological disease. healthy school children is able to follow commands and able to understand.

Description

Inclusion Criteria: healthy school going children, Male and female, Age between eight-13 years, Able to understand commands, Obey simple comments

Exclusion Criteria: neurological diseases, disease of the skin, skin rashes, Non cooperative child, other medical conditions that prevent the from participating in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
distance in millimeter
Time Frame: 3 times
distance between black pen marker and red pen marker point measure
3 times

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maharishi Markendeswar University (Deemed to be University)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Krati Omar, BPT, (MPT), Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation

Publications and helpful links

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General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 12, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 3, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 4, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MMDU/IEC/1188
  • U1111-1214-2489 (OTHER: UTN by WHO International Clinical Trial Registry)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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