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Completed

NCT Number: NCT00133861

Botulinum Toxin Efficiency on Spasticity of Rectus Femoris and Semitendinosus Muscles as Functional Agonist and Antagonist Muscles

The aim of the study is to confirm the functional improvement obtained through treatment of spasticity on 2 agonist and antagonist muscles. The hypothesis is that treatment of both muscles gives a better and longer functional improvement than treatment of only one muscle. The target muscles are the rectus femoris and semitendinosus and the treatment is botulinum toxin. Clinical assessment (passive range of motion of the lower limbs, spasticity level, functional scales and subjective feeling) and gait analysis data (kinematics and kinetics data) are collected. Evaluations take place before treatment, 2 months and 6 months after treatment.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hôpital Edouard Herriot - Pavillon T bis

Lyon, 69003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients between 7 to 17 years old
  • Cerebral palsy children with walking ability (even with crutch or knee-walker) allowing gait analysis.
  • Patients with functional status allowing the use of botulinum toxin on target muscles.

Exclusion criteria

  • Patients under 7 years old
  • Patients up to 17 years old
  • Patients in whom botulinum toxin is contra-indicated
  • Patients who received botulinum toxin within a 6 month period before the beginning of the study

Treatment and study plan

Botulinum toxin

Drug

Primary outcomes

  1. Clinical evaluation of the passive range of motion of the lower limbs

Secondary outcomes

  1. Evaluation of the spasticity using Tardieu Scale, Ashworth Scale and Ely test

  2. Evaluation of functional outcome using Gross Motor Function Measure and Gillette Functional Assessment, subjective evaluation, physiological cost index

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Botulinum Toxin Efficiency on Spasticity of Rectus Femoris and Semitendinosus Muscles as Functional Agonist and Antagonist Muscles. Assessment of Efficiency of Botulinum Toxin on Spasticity in Agonist and Antagonist Muscles Using Clinical Assessment and Gait Analysis in Cerebral Palsy Children: Rectus Femoris and Semitendinosus

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Aug 24, 2005
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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