The Evaluation of Medial Longitudinal Arch Morphology in Children With Spastic Diplegic Cerebral Palsy by Arch Height Index Measurement Method

August 8, 2024 updated by: Levent Karataş, Gazi University

The Evaluation of Medial Longitudinal Arch Morphology in Children With Spastic Diplegic Cerebral Palsy by Arch Height Index Measurement Method: A Pilot Study

Foot deformities are one of the most common orthopedic problems in patients with cerebral palsy(CP). Various methods have been proposed to evaluate foot morphology. Arch height index (AHI) measurement is a simple and quantitative method that can be applied in outpatient settings to evaluate the morphology of the medial longitudinal arch(MLA) of the foot. In this study, we aim to investigate the feasibility of AHI measurement in children with CP and, to identify other clinical findings that may be related to foot arch height determined by the AHI method.

Study Overview

Detailed Description

Cerebral palsy (CP) is a posture, movement, and motor dysfunction that occurs as a result of non-progressive damage of the developing brain during the intrauterine period or early childhood. Foot deformities, including pes planus and pes cavus, are common in children with CP and deteriorate posture and mobility due to its progressive nature and accompanying pain. Spasticity, muscle imbalances, soft tissue changes, and subsequent skeletal disorders are blamed for foot deformities in patients with CP.

Some methods such as foot posture index, navicular drop test, footprint methods, and radiological imaging have been described to identify and evaluate the MLA and foot/ankle posture. Arch height index (AHI) measurement is a novel method that evaluates especially medial longitudinal arch(MLA) morphology, with proven validity and reliability. It is essentially based on the measurement of the dorsum height and the length of the foot by using various caliper systems during varying degrees of load-bearing like sitting or standing. AHI measurement has some advantages over other methods. Measuring AHI during varying degrees of load-bearing such as sitting or standing allows us to quantitatively assess the mobility of the MLA. AHI measurement should be preferred in patients with foot sole skin disorders where footprint measurement methods are inefficient. Its results are not affected by some factors such as x-ray tube angle differences in foot radiography. It does not pose a risk of radiation exposure and is easy to apply. However, there is no data on the effectiveness of the AHI method in determining the MLA morphology in children with CP.

The first hypothesis of this study is that AHI measurement results in patients with CP correlate with data obtained from standard foot radiographs. The second aim of the study is to investigate the relationship between MLA morphology and other findings such as joint range of motion and spasticity of lower extremity muscles in patients with CP.

Patients with spastic diplegic cerebral palsy who were admitted to the Physical Medicine and Rehabilitation Department of our hospital will be evaluated in terms of eligibility criteria for the study. Eligible patients will be informed about the trial, and informed consent will be obtained from those who agree to participate. It was planned to recruit 24 subjects with a correlation coefficient of 0.8, a power of 0.90, and a margin of error of 0.05 to determine the correlation between AHI and quantitative foot radiography data.

Demographic data, body mass indexes, physical examination findings including gait patterns, ankle and foot range of motion and tone of the certain lower extremity muscles of participants will be recorded. MLA morphology will be evaluated by foot radiographs and AHI measurements. The AHI measurement will be made both in the bipedal standing and in the sitting position with both feet calmly on the ground. AHI will be calculated by proportioning the height of the dorsum measured from the middle 1/2 of the total length of the foot to truncated foot length.

Study Type

Observational

Enrollment (Actual)

20

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

      • Ankara, Turkey, 06560
        • Gazi University Hospital, Department of Physical Medicine and Rehabilitation

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

5 years to 17 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study cohort will consist of patients with spastic diplegic cerebral palsy who were admitted to our outpatient and inpatient clinics of the Physical Medicine and Rehabilitation Department. Every subject meeting the criteria of inclusion is going to be included in the study via a consecutive participant sampling method.

Description

Inclusion Criteria:

  • Being diagnosed with spastic diplegic cerebral palsy
  • Being between the ages of 5-17
  • Agree to participate in the study

Exclusion Criteria:

  • Excessive spasticity and Achilles contracture that prevents heel contact during stance
  • Botulinum toxin injection into the calf muscles in the last 3 months
  • Prior orthopedic surgery of the Achilles tendon, foot, or ankle
  • Radiculopathy, plexus, or peripheral nerve disorder involving the lower extremities

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

Cohorts and Interventions

Group / Cohort
Cohort 1
The study cohort will consist of patients with spastic diplegic cerebral palsy who were admitted to our outpatient and inpatient clinics of the Physical Medicine and Rehabilitation Department.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arch Height Index while bipedeal standing
Time Frame: Initial evaluation of the participant
The ratio of the height of the dorsum measured from the middle 1/2 of the total length of the foot to truncated foot length while bipedal standing
Initial evaluation of the participant
Arch Height Index while sitting
Time Frame: Initial evaluation of the participant
he ratio of the height of the dorsum measured from the middle 1/2 of the total length of the foot to truncated foot length while sitting with feet calmly on the ground
Initial evaluation of the participant
Navicular Index
Time Frame: Initial evaluation of the participant
The ratio of the height of the navicular bone from the ground to the height of the medial longitudinal arch of the foot on lateral foot radiograph.
Initial evaluation of the participant
Calcaneal Inclination Angle
Time Frame: Initial evaluation of the participant
Angle formed by a line tangent to the inferior cortex of the calcaneus and an horizontal reference line of the plantar plane on lateral foot radiograph.
Initial evaluation of the participant
Lateral Talo-first metatarsal Angle
Time Frame: Initial evaluation of the participant
Angle formed by the longitudinal axis of the first metatarsal shaft and the longitudinal axis of the talus on lateral foot radiograph.
Initial evaluation of the participant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Popliteal angle
Time Frame: Initial evaluation of the participant
Popliteal angle was defined as the acute angle between tibia and femur when the knee joint was passively extended with the hip flexed 90 degrees.
Initial evaluation of the participant
Ankle range of motion
Time Frame: Initial evaluation of the participant
The degree of flexion, extension, inversion, and eversion of the ankle joint that measured regarding the neutral zero methods.
Initial evaluation of the participant
The degree of spasticity of the certain muscles of the lower extremities
Time Frame: Initial evaluation of the participant
The tonus of hip flexor, hip adductor, knee extensor, knee flexor, ankle plantar flexor, and ankle invertor muscles will be evaluated by the Modified Ashworth Scale. Achilles' tendon tightness will be evaluated by the Silfverskiöld Test.
Initial evaluation of the participant

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait pattern
Time Frame: Initial evaluation of the participant
Based on the visual evaluation, the patient's gait pattern will be determined. (true crop, visible crop, squat gait, knee jump or mixed)
Initial evaluation of the participant

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: Murat Zinnuroğlu, MD, Gazi University Faculty of Medicine
  • Principal Investigator: Levent Karataş, MD, Gazi University Faculty of Medicine

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.

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)

July 15, 2021

Primary Completion (Actual)

July 31, 2024

Study Completion (Actual)

July 31, 2024

Study Registration Dates

First Submitted

August 23, 2021

First Submitted That Met QC Criteria

August 23, 2021

First Posted (Actual)

August 27, 2021

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 8, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Diplegic Cerebral Palsy With Spasticity

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