- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03546712
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
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
Observational
Enrollment (Actual)
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
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Haryana
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Ambala, Haryana, India, 133207
- Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation
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Ambala, Haryana, India, 133207
- Asir John Samuel
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
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
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.
Investigators
- Principal Investigator: Krati Omar, BPT, (MPT), Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Pinto JM, Kern DW, Wroblewski KE, Chen RC, Schumm LP, McClintock MK. Sensory function: insights from Wave 2 of the National Social Life, Health, and Aging Project. J Gerontol B Psychol Sci Soc Sci. 2014 Nov;69 Suppl 2(Suppl 2):S144-53. doi: 10.1093/geronb/gbu102.
- Ackerley R, Carlsson I, Wester H, Olausson H, Backlund Wasling H. Touch perceptions across skin sites: differences between sensitivity, direction discrimination and pleasantness. Front Behav Neurosci. 2014 Feb 19;8:54. doi: 10.3389/fnbeh.2014.00054. eCollection 2014.
- Croy I, Sehlstedt I, Wasling HB, Ackerley R, Olausson H. Gentle touch perception: From early childhood to adolescence. Dev Cogn Neurosci. 2019 Feb;35:81-86. doi: 10.1016/j.dcn.2017.07.009. Epub 2017 Aug 18.
- Rigato S, Banissy MJ, Romanska A, Thomas R, van Velzen J, Bremner AJ. Cortical signatures of vicarious tactile experience in four-month-old infants. Dev Cogn Neurosci. 2019 Feb;35:75-80. doi: 10.1016/j.dcn.2017.09.003. Epub 2017 Sep 14.
- Harvie DS, Kelly J, Buckman H, Chan J, Sutherland G, Catley M, Novak J, Tuttle N, Sterling M. Tactile acuity testing at the neck: A comparison of methods. Musculoskelet Sci Pract. 2017 Dec;32:23-30. doi: 10.1016/j.msksp.2017.07.007. Epub 2017 Jul 29.
- Chai G, Sui X, Li S, He L, Lan N. Characterization of evoked tactile sensation in forearm amputees with transcutaneous electrical nerve stimulation. J Neural Eng. 2015 Dec;12(6):066002. doi: 10.1088/1741-2560/12/6/066002. Epub 2015 Sep 24.
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)
November 12, 2018
Primary Completion (ACTUAL)
March 3, 2019
Study Completion (ACTUAL)
March 4, 2019
Study Registration Dates
First Submitted
May 23, 2018
First Submitted That Met QC Criteria
May 23, 2018
First Posted (ACTUAL)
June 6, 2018
Study Record Updates
Last Update Posted (ACTUAL)
April 8, 2019
Last Update Submitted That Met QC Criteria
April 5, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID 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
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