Ankle Foot Orthosis on Muscle Activity in Cerebral Palsy

March 5, 2024 updated by: Delta University for Science and Technology

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

30

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
muscle activity by Electromyography device
Time Frame: up to 12 months
activity of gastrocnemius ad tibialis anterior muscle by Electromyography device
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Delta University for Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2024

Primary Completion (Estimated)

October 15, 2024

Study Completion (Estimated)

November 30, 2024

Study Registration Dates

First Submitted

February 20, 2024

First Submitted That Met QC Criteria

March 1, 2024

First Posted (Actual)

March 4, 2024

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • delta2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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