Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532981
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
The Effect of AFOs on the EMG of Children With CP
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of the Ankle-foot Orthosis on Muscle Activity in the Lower Limbs in Children With Cerebral Palsy
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Children with cerebral palsy CP have altered gait patterns as a result of primary and secondary symptoms Ankle-foot orthoses AFOs are frequently used to improve their gait Despite evidence of AFO-effects on gait kinetics and -kinematics the effects on muscle activity remain unclear
This study will investigate the effect of AFOs on the amplitude and timing as well as the co-activation of lower limb muscle activity in children with spastic CP
This study will investigate the effect of AFOs on the amplitude and timing as well as the co-activation of lower limb muscle activity in children with spastic CP
Detailed Description:
With a prevalence of two to three per 1000 live births Cerebral Palsy CP is the most common motor disability of childhood Improving disturbed gait in ambulatory children with CP is an important treatment goal because it is associated with functional independence and participation of children in the society It is a common practice to prescribe ankle-foot orthoses AFO for ambulatory children to improve their gait prevent secondary deformities provide an improved base of support and compensate for muscle weakness
Previous research highlighted that there is a direct effect on the muscle activity of the distal muscles and an indirect effect on the proximal muscles However the impact of the AFO on the muscle activity of the plantar and dorsiflexors is clinically relevant since reduced muscle activity may lead to muscle atrophy and altered motor control Therefore more research is needed on the effect of AFOs on the medial gastrocnemius and the tibialis anterior in both unilaterally and bilaterally involved children Moreover the impact of the AFO on the muscle activity of the quadriceps apart from the hamstrings needs to be further explored as well
The purpose of the current study is to investigate the effect of the AFO on muscle activity in the distal and proximal leg muscles of children with CP while walking
On the measurement day subjects will first receive a standard clinical examination preceding the clinical overground three-dimensional gait analysis 3DGA that is planned as a routine clinical follow-up at the CMAL clinical motion analysis laboratory extended with an additional 3DGA on the treadmill The treadmill gait laboratory and overground gait laboratory are across the hall from each other which makes it possible for the subject to walk from one to the other gait laboratory in just a minute During the 3DGA kinematic kinetic and EMG-data will be collected
Previous research highlighted that there is a direct effect on the muscle activity of the distal muscles and an indirect effect on the proximal muscles However the impact of the AFO on the muscle activity of the plantar and dorsiflexors is clinically relevant since reduced muscle activity may lead to muscle atrophy and altered motor control Therefore more research is needed on the effect of AFOs on the medial gastrocnemius and the tibialis anterior in both unilaterally and bilaterally involved children Moreover the impact of the AFO on the muscle activity of the quadriceps apart from the hamstrings needs to be further explored as well
The purpose of the current study is to investigate the effect of the AFO on muscle activity in the distal and proximal leg muscles of children with CP while walking
On the measurement day subjects will first receive a standard clinical examination preceding the clinical overground three-dimensional gait analysis 3DGA that is planned as a routine clinical follow-up at the CMAL clinical motion analysis laboratory extended with an additional 3DGA on the treadmill The treadmill gait laboratory and overground gait laboratory are across the hall from each other which makes it possible for the subject to walk from one to the other gait laboratory in just a minute During the 3DGA kinematic kinetic and EMG-data will be collected
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None