Gait Disorder, SensorimotorNCT05692791
Idiopathic Toe-Walking Position Sensation
An observational study of Gait Disorder, Sensorimotor, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effect of plantar two-point discrimination on hip-knee-ankle position sense in children with toe walking.The main questions it aims to answer are: Are two-point discrimination and light pressure sensation in the plantar region affected in children with idiopathic toe gait?… Read more about this study
- Who is it for?
- Ages 3 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Gait Disorder, Sensorimotor
- What is being tested?
- Two-point Discrimination Test and Semmes-Weinstein monofilament test
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2024to 25 Jun 2024
- 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 3 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children who have idiopathic toe walking in the experimental group and healthy children in the control group with the same ages.
Who may be able to join
- Having idiopathic toe walking diagnosis
Who cannot join
- Having another known neuromuscular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Two-point Discrimination and Position Perception in Children Who Have Idiopathic Toe Walk
The aim of this study is to investigate the effect of plantar two-point discrimination on hip-knee-ankle position sense in children with toe walking.The main questions it aims to answer are:
- Are two-point discrimination and light pressure sensation in the plantar region affected in children with idiopathic toe gait?
- Does the two-point discrimination in the plantar in general and the heel in particular affect the position sense of the hip-knee and ankle?
Read the detailed description
Children who tend to walk on toes after they should have developed a heel-toe gait are diagnosed with idiopathic toe walking (ITW).Cerebral palsy, muscular dystrophy, and orthopaedic problems such congenital talipes equinus are some of the diseases that are frequently linked to a toe-walking gait. A diagnosis of ITW is made when there is no physical or medical cause for the absence of a heel strike. Five percent of healthy children are estimated to have ITW, and boys are more likely than girls to be affected. Reduced ankle range of motion is prevalent symptom in children with ITW. Since ITW often manifests as symmetrical tiptoe walking in children, reports showing a comparable bilateral reduction in ankle range of motion at both lower limbs indicate the symmetrical character of this gait type. Lower vibration perception thresholds, a tendency to be left-handed, and noticeable variations in sensory seeking and modulation scores are all characteristics of children with an ITW gait.
The small fibers that innervate the cutaneous receptors (such as Merkel's cell, Pacinian corpuscles, Meissner's corpuscles, and Ruffini endings in the skin) are more crucial for postural control than the large fibers that innervate the major muscle spindles and the Golgi tendon organs. Standing balance control is more dependent on Merkel's cells and Ruffini endings (slow adapting receptors), which are in charge of touch and pressure sensitivity, than it is on Meissner's and Pacinian corpuscles (rapid adapting receptors), which are in charge of vibrotactile sensitivity.Additionally, it has been demonstrated that tactile sensation in the foot sole affects the activity of the tibialis anterior muscle as well as the regulation of gait pattern at lower limb joints. These investigations support the notion that cutaneous feeling is crucial for preserving postural and gait stability.The literature states that plantar pressure and sensory changes have disruptive effects on postural control.The aim of this study is to investigate the effect of plantar two-point discrimination on hip-knee-ankle position sense in children with toe walking.
- Conditions
- Gait Disorder, Sensorimotor
- Being tested
- Two-point Discrimination Test, Semmes-Weinstein monofilament test
- Keywords
- Idiopathic Toe Walking
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two-point Discrimination TestDiagnostic test
Two-point discrimination (2PD) is the ability to discern that two nearby objects touching the skin are truly two distinct points, not one. It is often tested with two sharp points during a neurological examination and is assumed to reflect how finely innervated an area of skin is.
Semmes-Weinstein monofilament testDiagnostic test
Semmes-Weinstein monofilament test is used to assess light touch sensations.
| Study group | Role | What they receive |
|---|---|---|
| ITW | Not described Receives: Diagnostic Test: Two-point Discrimination Test; Diagnostic Test: Semmes-Weinstein monofilament test | |
| Control Group | Not described Receives: Diagnostic Test: Two-point Discrimination Test; Diagnostic Test: Semmes-Weinstein monofilament test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip-Knee-Ankle Joint Position Sense
Position the body segment being tested and then passively position the individual's joint in space. Hold the lateral surfaces of the limb to minimize cues from touch and pressure sensations.
Move the body segment into a position and either have the patient maintain the position or assist the patient in maintaining the position if needed.
Have the patient duplicate the position with the opposite extremity. The procedure is repeated enough times to conclude if joint position sense is intact or impaired. A suggested minimum number of trials is five per joint.
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start30 Apr 2024
- Primary completion25 Jun 2024
- Study completion25 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gait Disorder, SensorimotorStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ömer Faruk ÖZÇELEP, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692791
- Sponsor's protocol ID
- AEUnivers
- Status last verified
- Jul 2024
- First submitted
- 12 Jan 2023
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: With mail
Publications
Silva PG, Jones A, Araujo PM, Natour J. Assessment of light touch sensation in the hands of systemic sclerosis patients. Clinics (Sao Paulo). 2014 Sep;69(9):585-8. doi: 10.6061/clinics/2014(09)02.
PubMed 25318088Westberry DE, Davids JR, Davis RB, de Morais Filho MC. Idiopathic toe walking: a kinematic and kinetic profile. J Pediatr Orthop. 2008 Apr-May;28(3):352-8. doi: 10.1097/BPO.0b013e318168d996.
PubMed 18362803
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Two-point Discrimination and Position Perception in Children Who Have Idiopathic Toe Walk
- ClinicalTrials.gov ID
- NCT05692791
- Acronym / sponsor ID
- AEUnivers
- Conditions
- Gait Disorder, Sensorimotor
- Keywords
- Idiopathic Toe Walking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 25 Jun 2024 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 20 Jan 2023 (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.
The aim of this study is to investigate the effect of plantar two-point discrimination on hip-knee-ankle position sense in children with toe walking.The main questions it aims to answer are:
- Are two-point discrimination and light pressure sensation in the plantar region affected in children with idiopathic toe gait?
- Does the two-point discrimination in the plantar in general and the heel in particular affect the position sense of the hip-knee and ankle?
Detailed description
Children who tend to walk on toes after they should have developed a heel-toe gait are diagnosed with idiopathic toe walking (ITW).Cerebral palsy, muscular dystrophy, and orthopaedic problems such congenital talipes equinus are some of the diseases that are frequently linked to a toe-walking gait. A diagnosis of ITW is made when there is no physical or medical cause for the absence of a heel strike. Five percent of healthy children are estimated to have ITW, and boys are more likely than girls to be affected. Reduced ankle range of motion is prevalent symptom in children with ITW. Since ITW often manifests as symmetrical tiptoe walking in children, reports showing a comparable bilateral reduction in ankle range of motion at both lower limbs indicate the symmetrical character of this gait type. Lower vibration perception thresholds, a tendency to be left-handed, and noticeable variations in sensory seeking and modulation scores are all characteristics of children with an ITW gait.
The small fibers that innervate the cutaneous receptors (such as Merkel's cell, Pacinian corpuscles, Meissner's corpuscles, and Ruffini endings in the skin) are more crucial for postural control than the large fibers that innervate the major muscle spindles and the Golgi tendon organs. Standing balance control is more dependent on Merkel's cells and Ruffini endings (slow adapting receptors), which are in charge of touch and pressure sensitivity, than it is on Meissner's and Pacinian corpuscles (rapid adapting receptors), which are in charge of vibrotactile sensitivity.Additionally, it has been demonstrated that tactile sensation in the foot sole affects the activity of the tibialis anterior muscle as well as the regulation of gait pattern at lower limb joints. These investigations support the notion that cutaneous feeling is crucial for preserving postural and gait stability.The literature states that plantar pressure and sensory changes have disruptive effects on postural control.The aim of this study is to investigate the effect of plantar two-point discrimination on hip-knee-ankle position sense in children with toe walking.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ITW | – | Diagnostic Test: Two-point Discrimination Test, Diagnostic Test: Semmes-Weinstein monofilament test |
| Control Group | – | Diagnostic Test: Two-point Discrimination Test, Diagnostic Test: Semmes-Weinstein monofilament test |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children who have idiopathic toe walking in the experimental group and healthy children in the control group with the same ages.
Key inclusion criteria (1 listed)
- Having idiopathic toe walking diagnosis
Key exclusion criteria (1 listed)
- Having another known neuromuscular disease
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 |
|---|---|---|
| Two-point Discrimination TestTwo-point discrimination (2PD) is the ability to discern that two nearby objects touching the skin are truly two distinct points, not one. It is often tested with two sharp points during a neurological examination and is assumed to reflect how finely innervated an area of skin is. | Diagnostic test | Control Group, ITW |
| Semmes-Weinstein monofilament testSemmes-Weinstein monofilament test is used to assess light touch sensations. | Diagnostic test | Control Group, ITW |
Primary outcome
Hip-Knee-Ankle Joint Position Sense
Time frame: 15 weeks
Position the body segment being tested and then passively position the individual's joint in space. Hold the lateral surfaces of the limb to minimize cues from touch and pressure sensations. Move the body segment into a position and either have the patient maintain the position or assist the patient in maintaining the position if needed. Have the patient duplicate the position with the opposite extremity. The procedure is repeated enough times to conclude if joint position sense is intact or impaired. A suggested minimum number of trials is five per joint.
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 26 Jul 2024.
- Background: PubMed 25318088Silva PG, Jones A, Araujo PM, Natour J. Assessment of light touch sensation in the hands of systemic sclerosis patients. Clinics (Sao Paulo). 2014 Sep;69(9):585-8. doi: 10.6061/clinics/2014(09)02.
- Background: PubMed 18362803Westberry DE, Davids JR, Davis RB, de Morais Filho MC. Idiopathic toe walking: a kinematic and kinetic profile. J Pediatr Orthop. 2008 Apr-May;28(3):352-8. doi: 10.1097/BPO.0b013e318168d996.
- Individual participant dataSharing planned: Yes. With mail
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gait Disorder, Sensorimotor, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Hip-Knee-Ankle Joint Position Sense (time frame: 15 weeks). 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 NCT05692791, which also lists 2 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 26 Jul 2024; AzTrials last refreshed its copy on 27 Oct 2026.