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Not yet recruitingNCT06291974Updated Mar 7, 2024

Ankle Foot Orthosis on Muscle Activity in Cerebral Palsy

An observational study in Cerebral Palsy Spastic Diplegia, sponsored by Delta University for Science and Technology. Not yet recruiting. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2024-03-07.

Sponsored by Delta University for Science and Technology · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2024, 1 year 11 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
30
Ages
6 Years to 12 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Cerebral Palsy Spastic Diplegia
03

In context

Muscle Spasticity

704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 162 observational studies indexed under Muscle Spasticity.

Browse Muscle Spasticity studies →

Lead sponsor

Delta University for Science and Technology is the lead sponsor of 82 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
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.

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

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.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testelectromyography

    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

06

What researchers measure

Primary outcomes

  1. muscle activity by Electromyography device

    activity of gastrocnemius ad tibialis anterior muscle by Electromyography device

    Time frame: up to 12 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06291974
Lead sponsor
Delta University for Science and Technology
Responsible party
Sponsor
First posted
Mar 4, 2024
Start date
Mar 15, 2024 (estimated)
Primary completion
Oct 15, 2024 (estimated)
Completion
Nov 30, 2024 (estimated)
Last update
Mar 7, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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