- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02814786
Dynamic Evaluation of Ankle Joint and Muscle Mechanics in Children With Spastic Equinus Deformity Due to Cerebral Palsy (EQUINUS)
In Vivo Dynamic Evaluation of Ankle Joint and Muscle Mechanics in Children With Spastic Equinus Deformity Due to Cerebral Palsy: Implications for Recurrent Equinus.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Brest, France, 29200
- Chru Brest
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Equinus cohort inclusion criteria:
- children between 7 and 14 years old
- with unilateral CP and GMFCS score of I or II
- with the presence of fixed equinus defined as a fixed limitation of dorsiflexion inferior to 0°
Control cohort inclusion criteria:
- age and gender matched to equinus cohort
- no history of lower limb musculo-skeletal injury in past 6 months
- no history of lower limb musculoskeletal surgery in past six months
- no contraindications to MRI
Equinus cohort exclusion criteria:
- history of lower limb musculo-skeletal surgery
- botulinum toxin injection in past 6 months
- contraindications to MRI
- Uncooperative patient who refused to sign the informed consent
- Patient unable to understand the protocol, under guardianship
- Patients not affiliated to the Social Security.
Control cohort exclusion criteria:
- Uncooperative patient who refused to sign the informed consent
- Patient unable to understand the protocol, under guardianship
- Patients not affiliated to the Social Security.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Equinus cohort
15 childrens who have a fixed equinus defined as a fixed limitation of dorsiflexion inferior to 0°. Interventions: MRI scanner and gait analysis |
This examination is divided in 2 parts:
Other Names:
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.
Other Names:
|
Experimental: Control cohort
In this cohort, there will be 15 childrens with age and gender matched to equinus cohort and with no history of lower limb musculo-skeletal injury in past 6 months. Interventions: MRI scanner and gait analysis |
This examination is divided in 2 parts:
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Talocrural joint flexion, pronation, and internal rotations
Time Frame: One year
|
Talocrural (talus relative to tibia) joint rotations and translations will be compared between two cohorts.
|
One year
|
Subtalar joint flexion, pronation, and internal rotations
Time Frame: one year
|
Subtalar (calcaneus relative to talus) joint rotations and translations will be compared between two cohorts.
|
one year
|
Achilles tendon moment arm (MAAT)
Time Frame: one year
|
MAAT is defined as a perpendicular 3D distance between Achilles' tendon line of action and the Medial-lateral Calcaneal axis.
Using calcaneal kinematics, MAAT value for each time frame will be quantified and compared between two cohorts.
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ankle joint kinematics (joint angles) during walking
Time Frame: one year
|
Walking gait parameters (ankle, knee, and hip joint angles) will be correlated with primary outcome measures
|
one year
|
Knee joint kinematics (joint angles) during walking
Time Frame: one year
|
Walking gait parameters (ankle, knee, and hip joint angles) will be correlated with primary outcome measures
|
one year
|
Hip joint kinematics (joint angles) during walking
Time Frame: one year
|
Walking gait parameters (ankle, knee, and hip joint angles) will be correlated with primary outcome measures
|
one year
|
Talocrural joint contact area
Time Frame: one year
|
Joint contact mechanics measures and will be compared between cohorts.
|
one year
|
Talocrural joint contact centroid location
Time Frame: one year
|
Joint contact mechanics measures and will be compared between cohorts.
|
one year
|
Subtalar joint contact area
Time Frame: one year
|
Joint contact mechanics measures and will be compared between cohorts.
|
one year
|
Subtalar joint contact centroid location
Time Frame: one year
|
Joint contact mechanics measures and will be compared between cohorts.
|
one year
|
Collaborators and Investigators
Sponsor
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 (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Brain Damage, Chronic
- Musculoskeletal Diseases
- Musculoskeletal Abnormalities
- Limb Deformities, Congenital
- Foot Deformities
- Foot Deformities, Acquired
- Foot Deformities, Congenital
- Lower Extremity Deformities, Congenital
- Cerebral Palsy
- Congenital Abnormalities
- Clubfoot
- Talipes
- Equinus Deformity
Other Study ID Numbers
- RB15-159 EQUINUS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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