Clinical trial NCT05025007: The Evaluation of Medial Longitudinal Arch Morphology in Children With Spastic Diplegic Cerebral Palsy by Arch Height Index Measurement Method
Official title: The Evaluation of Medial Longitudinal Arch Morphology in Children With Spastic Diplegic Cerebral Palsy by Arch Height Index Measurement Method: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diplegic Cerebral Palsy With Spasticity
Pes; Deformity
Keywords: Cerebral Palys
Children
Arch Height Index
Medial Longitudinal Arch
Pes Planus
Pes Cavus
Flatfoot
Foot Deformity
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Arch Height Index while bipedeal standing
timeFrame: Initial evaluation of the participant
measure: Arch Height Index while sitting
timeFrame: Initial evaluation of the participant
measure: Navicular Index
timeFrame: Initial evaluation of the participant
measure: Calcaneal Inclination Angle
timeFrame: Initial evaluation of the participant
measure: Lateral Talo-first metatarsal Angle
timeFrame: Initial evaluation of the participant
Secondary outcomes:
measure: Popliteal angle
timeFrame: Initial evaluation of the participant
measure: Ankle range of motion
timeFrame: Initial evaluation of the participant
measure: The degree of spasticity of the certain muscles of the lower extremities
timeFrame: Initial evaluation of the participant
Other outcomes:
measure: Gait pattern
timeFrame: Initial evaluation of the participant
Locations:
city: Ankara
country: Turkey
facility: Gazi University Hospital, Department of Physical Medicine and Rehabilitation
Study officials:
affiliation: Gazi University Faculty of Medicine
name: Murat Zinnuroğlu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University Faculty of Medicine
name: Levent Karataş, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.