NCT05025007

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2021

Typical duration 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

Study Start

First participant enrolled

July 15, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 23, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 27, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

3 years

First QC Date

August 23, 2021

Last Update Submit

August 8, 2024

Conditions

Keywords

Cerebral PalysChildrenArch Height IndexMedial Longitudinal ArchPes PlanusPes CavusFlatfootFoot Deformity

Outcome Measures

Primary Outcomes (5)

  • Arch Height Index while bipedeal standing

    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

    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

    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

    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

    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 Outcomes (3)

  • Popliteal angle

    Initial evaluation of the participant

  • Ankle range of motion

    Initial evaluation of the participant

  • The degree of spasticity of the certain muscles of the lower extremities

    Initial evaluation of the participant

Other Outcomes (1)

  • Gait pattern

    Initial evaluation of the participant

Study Arms (1)

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.

Eligibility Criteria

Age60 Months - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Hospital, Department of Physical Medicine and Rehabilitation

Ankara, 06560, Turkey (Türkiye)

Location

Related Publications (3)

  • Min JJ, Kwon SS, Sung KH, Lee KM, Chung CY, Park MS. Progression of planovalgus deformity in patients with cerebral palsy. BMC Musculoskelet Disord. 2020 Mar 3;21(1):141. doi: 10.1186/s12891-020-3149-0.

    PMID: 32127007BACKGROUND
  • Butler RJ, Hillstrom H, Song J, Richards CJ, Davis IS. Arch height index measurement system: establishment of reliability and normative values. J Am Podiatr Med Assoc. 2008 Mar-Apr;98(2):102-6. doi: 10.7547/0980102.

    PMID: 18347117BACKGROUND
  • Drefus LC, Kedem P, Mangan SM, Scher DM, Hillstrom HJ. Reliability of the Arch Height Index as a Measure of Foot Structure in Children. Pediatr Phys Ther. 2017 Jan;29(1):83-88. doi: 10.1097/PEP.0000000000000337.

    PMID: 27984478BACKGROUND

MeSH Terms

Conditions

Foot Deformities, CongenitalFlatfootTalipes CavusFoot Deformities

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesTalipesFoot Deformities, Acquired

Study Officials

  • Murat Zinnuroğlu, MD

    Gazi University Faculty of Medicine

    PRINCIPAL INVESTIGATOR
  • Levent Karataş, MD

    Gazi University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, Principal Investigator

Study Record Dates

First Submitted

August 23, 2021

First Posted

August 27, 2021

Study Start

July 15, 2021

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

August 9, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations