Recruiting NA Spastic Cerebral Palsy

New treatment option for Spastic Cerebral Palsy

Official title Feasibility Nutritional Supplements for Muscle Growth in CP

ClinicalTrials.gov ID: NCT06044168

What this study is testing

What it's testing
The purpose of this study is to investigate the feasibility of a 10-week plan with a nutritional supplement (leucine) and to perform pilot analyses on the effect of leucine on macroscopic muscle morphology in children with cerebral palsy.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 4 to 10

You may be able to join if

  • Spastic Cerebral Palsy (diagnosed by a neuro-pediatrician from the CP Reference Centre of the University Hospital Leuven)
  • Uni- of bilateral involvement
  • Level II or III on the Gross Motor Function Classification System (GMFCS)
  • Muscle volume for the medial gastrocnemius (target muscle) of at least 20% compared to the expected muscle volume in age-matched typically developing...

You likely can't join if

  • Presence of dyskinesia or ataxia
  • Severe co-morbidities
  • Botulinum toxin treatment ten months prior to assessment
  • Previous orthopedic or neurosurgery
  • Severe ankle deformities preventing fitting in test positions
  • Ankle range of motion (ROM) \<30% of normal values

The study team makes the final eligibility decision.

Where it's taking place

  • Leuven, Vlaams-Brabant, Belgium

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 4 years to 10 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Leuven, Vlaams-Brabant, Belgium. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.