Ankle Foot Orthosis on Muscle Activity in Cerebral Palsy

NCT06291974 | Not Yet Recruiting FDA Device

• 1 other identifier: delta2024
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Cerebral Palsy Spastic Diplegia

Outcome Measures

Primary Outcomes (1)

• muscle activity by Electromyography device

  activity of gastrocnemius ad tibialis anterior muscle by Electromyography device

  up to 12 months

Interventions

electromyography DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

children diagnosed with cp spastic diplegia with postural instability will represent the sample of this study. They will be selected from the clinic of faculty of physical therapy, delta university and my private clinic.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Delta University for Science and Technology: lead

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Electromyography

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electrodiagnosis; Diagnostic Techniques and Procedures; Diagnosis; Myography

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: March 4, 2024
• Study Start: March 15, 2024
• Primary Completion: October 15, 2024
• Study Completion: November 30, 2024
• Last Updated: March 7, 2024

Record last verified: 2024-02