- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05025007
The Evaluation of Medial Longitudinal Arch Morphology in Children With Spastic Diplegic Cerebral Palsy by Arch Height Index Measurement Method
The Evaluation of Medial Longitudinal Arch Morphology in Children With Spastic Diplegic Cerebral Palsy by Arch Height Index Measurement Method: A Pilot Study
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ankara, Turkey, 06560
- Gazi University Hospital, Department of Physical Medicine and Rehabilitation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Arch Height Index while bipedeal standing
Time Frame: Initial evaluation of the participant
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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
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Initial evaluation of the participant
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Arch Height Index while sitting
Time Frame: Initial evaluation of the participant
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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
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Initial evaluation of the participant
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Navicular Index
Time Frame: Initial evaluation of the participant
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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.
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Initial evaluation of the participant
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Calcaneal Inclination Angle
Time Frame: Initial evaluation of the participant
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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.
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Initial evaluation of the participant
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Lateral Talo-first metatarsal Angle
Time Frame: Initial evaluation of the participant
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Angle formed by the longitudinal axis of the first metatarsal shaft and the longitudinal axis of the talus on lateral foot radiograph.
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Initial evaluation of the participant
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Popliteal angle
Time Frame: Initial evaluation of the participant
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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.
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Initial evaluation of the participant
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Ankle range of motion
Time Frame: Initial evaluation of the participant
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The degree of flexion, extension, inversion, and eversion of the ankle joint that measured regarding the neutral zero methods.
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Initial evaluation of the participant
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The degree of spasticity of the certain muscles of the lower extremities
Time Frame: Initial evaluation of the participant
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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.
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Initial evaluation of the participant
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Gait pattern
Time Frame: Initial evaluation of the participant
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Based on the visual evaluation, the patient's gait pattern will be determined.
(true crop, visible crop, squat gait, knee jump or mixed)
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Initial evaluation of the participant
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Collaborators and Investigators
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
General Publications
- 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.
- 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. Erratum In: J Am Podiatr Med Assoc. 2008 Jul-Aug;98(4):277.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Cerebral Palys and Foot
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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