Ankle Foot Orthosis on Muscle Activity in Cerebral Palsy

Cerebral Palsy Spastic Diplegia Clinical Trial

Official title:

Efficacy of Solid Versus Ground Reaction Ankle Foot Orthosis on Muscular Activity in Children With Spastic Diplegic in Cerebral Palsy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06291974
• Other study ID #: delta2024
• Status: Not yet recruiting
• Start date: March 15, 2024
• Est. completion date: November 30, 2024

Study information

• Verified date: February 2024
• Source: Delta University for Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To compare the effect of solid ankle foot orthosis and ground reaction foot orthosis on the muscle activity in children with spastic diplegic cerebral palsy (Gross Motor Functional Classification Scale III).

Description:

Few studies have examined muscular activity via electromyography (EMG) during quiet standing in children with cp. A few studies have examined the benefits of ground reaction ankle foot orthosis, showing that it could effectively reduce or eliminate the crouch position in children with spastic cerebral palsy however little is known about the benefits of GRAFOs on postural control mechanisms in static standing in children with CP. Previous Studies suggested that appropriate tuning of ankle foot orthosis properties may reduce muscle demand for children with CP. So, this study may be a guide in management of postural instability in children with spastic diplegic cerebral palsy in standing position.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 30, 2024
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• Spasticity level II in lower limb muscles according to Modified Ashworth Scale.
• Able to follow order.
• Aged from 6 to 12 years old.

Exclusion Criteria:

• Visual or obvious detected vestibular sensory disorders or cerebellar disease.
• Botox injection in the last 6 months.
• Cognitive deficits or disturbed conscious level.

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy Spastic Diplegia
• Muscle Spasticity

Intervention

Diagnostic Test:
• electromyography
Surface Electromyography (SEMG) is a measurement of the electrical activity in muscles as a byproduct of contraction. It is the summation of action potentials from the muscle fibers under the electrodes placed on the skin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Delta University for Science and Technology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	muscle activity by Electromyography device	activity of gastrocnemius ad tibialis anterior muscle by Electromyography device	up to 12 months