HealthyNCT03546712
Estimating Error in Locating Touch Sensation on Forearm in Healthy Middle School Going Children
An observational study of Healthy, run by Maharishi Markendeswar University (Deemed to be University) at 2 sites in India.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tactile Localization
- How many people
- 365 participants
- Where
- 2 sitesIndia
- Study dates
- 12 Nov 2018to 4 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
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.
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
Trial locations and contacts
2 sites in 1 country.
India2 sites
Asir John Samuel
Ambāla, Haryana, 133207
Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation
Ambāla, Haryana, 133207
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Tactile Localization
- Keywords
- Acuity, children, forearm, perception, touch location
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tactile LocalizationOther
tactile localization is help to assess touch sensation
What is being measured
The primary outcome is the main question the study is designed to answer.
distance in millimeter
distance between black pen marker and red pen marker point measure
Measured: 3 times
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start12 Nov 2018
- Primary completion3 Mar 2019
- Study completion4 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asir John Samuel, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- Krati Omar, BPT, (MPT), Principal investigator, Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546712
- Sponsor's protocol ID
- MMDU/IEC/1188
- Other IDs
- U1111-1214-2489
- Status last verified
- Apr 2019
- First submitted
- 23 May 2018
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
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.
PubMed 25360015Ackerley 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.
PubMed 24600368Croy 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.
PubMed 28927641Rigato 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.
PubMed 28942240Harvie 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.
PubMed 28800436Chai 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.
PubMed 26401550
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard References Norms for Tactile Localization Acuity in Upper Limb Among the Asymptomatic Middle School Children: A Normative Research
- ClinicalTrials.gov ID
- NCT03546712
- Acronym / sponsor ID
- MMDU/IEC/1188
- Conditions
- Healthy
- Keywords
- Acuity, children, forearm, perception, touch location
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)University, hospital or other
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 3 Mar 2019 (actual)
- Study completion
- 4 Mar 2019 (actual)
- First posted
- 6 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tactile Localizationtactile localization is help to assess touch sensation | Other | – |
Primary outcome
distance in millimeter
Time frame: 3 times
distance between black pen marker and red pen marker point measure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
- Background: PubMed 25360015Pinto 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.
- Background: PubMed 24600368Ackerley 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.
- Background: PubMed 28927641Croy 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.
- Background: PubMed 28942240Rigato 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.
- Background: PubMed 28800436Harvie 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.
- Background: PubMed 26401550Chai 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.
- Tactile acuity testing at the neck: A comparison of methodsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krati Omar, BPT, (MPT) principal investigator
Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Maharishi Markendeswar University (Deemed to be University) at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
distance in millimeter (time frame: 3 times). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03546712, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2019.