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Dynamic Evaluation of Ankle Joint and Muscle Mechanics in Children With Spastic Equinus Deformity Due to Cerebral Palsy

NCT02814786 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-04-03

No results posted yet for this study

Summary

This research will lead to the first evaluation of intrinsic and dynamic joint and muscle mechanics of equinus in cerebral palsy. It would provide a direct cause and effect relationship between equinus and bone deformity. Mechanical insights to the pathophysiology of the targeted muscles will lead to better understanding and, thus, to a better medical and surgical management of equinus deformity. Secondary aim will provide an important insight whether key gait parameters can be exclusively relied upon for surgical treatment planning and evaluation. In a medium-term perspective, depending upon the results of this study, dynamic MRI of the ankle joint may serve as a guiding tool for fixed equinus surgery in case of cerebral palsy.

Conditions

  • Equinus Deformity

Interventions

RADIATION

MRI scanner

This examination is divided in 2 parts: * Passive movement: after placing the ankle joint in the fixture, each child will be asked to relax the lower limb musculature and then the fixture will be cyclically moved by a technician at a speed which does not trigger spasticity. * Active movement: no technician will be present and children will be asked to perform voluntary plantar-dorsiflexion between the extreme positions on the beat of the metronome.

OTHER

Gait analysis

For gait evaluation, each child will undergo a lower limb gait analysis in a motion analysis laboratory equipped with Camera system and 4 AMTI force plates Sixteen reflective markers will be placed on the lower limbs. Each child will walk bare foot and gait will be recorded during each of five 10-meter trials. A velocity of 1 m/s (+/- 10%) will be imposed using a stop watch in order to eliminate the influence of velocity on gait kinematics and kinematics while comparing across subjects. Each child will be allowed to walk for 5 minutes after attaching the reflective markers and before recording the gait data. In addition to the joint kinematics, joint powers and moments will be computed using an inverse dynamics method.

Sponsors & Collaborators

  • University Hospital, Brest

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-08
Primary Completion
2019-04-18
Completion
2020-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02814786 on ClinicalTrials.gov