NCT05692791

Brief 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?
  • 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?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

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

January 12, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 20, 2023

Completed
1.3 years until next milestone

Study Start

First participant enrolled

April 30, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2024

Completed
Last Updated

July 26, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

January 12, 2023

Last Update Submit

July 25, 2024

Conditions

Keywords

Idiopathic Toe Walking

Outcome Measures

Primary Outcomes (1)

  • 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.

    15 weeks

Study Arms (2)

ITW

Diagnostic Test: Two-point Discrimination TestDiagnostic Test: Semmes-Weinstein monofilament test

Control Group

Diagnostic Test: Two-point Discrimination TestDiagnostic Test: Semmes-Weinstein monofilament test

Interventions

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.

Control GroupITW

Semmes-Weinstein monofilament test is used to assess light touch sensations.

Control GroupITW

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children who have idiopathic toe walking in the experimental group and healthy children in the control group with the same ages.

You may qualify if:

  • Having idiopathic toe walking diagnosis

You may not qualify if:

  • Having another known neuromuscular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahi Evran University

Kırşehir, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 25318088BACKGROUND
  • Westberry 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.

    PMID: 18362803BACKGROUND

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 12, 2023

First Posted

January 20, 2023

Study Start

April 30, 2024

Primary Completion

June 25, 2024

Study Completion

June 25, 2024

Last Updated

July 26, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

With mail

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
6 months after publishing

Locations