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

Cerebral Palsy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00133861
• Other study ID #: 2004.351
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 23, 2005
• Last updated: June 30, 2008
• Start date: April 2005
• Est. completion date: June 2008

Study information

• Verified date: June 2008
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 17 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Muscle Spasticity

Intervention

Drug:
• Botulinum toxin

Locations

Country	Name	City	State
France	Hôpital Edouard Herriot - Pavillon T bis	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical evaluation of the passive range of motion of the lower limbs
Secondary	Evaluation of the spasticity using Tardieu Scale, Ashworth Scale and Ely test
Secondary	Evaluation of functional outcome using Gross Motor Function Measure and Gillette Functional Assessment, subjective evaluation, physiological cost index