Back to resultsBotulinum Toxin Efficiency on Spasticity of Rectus Femoris and Semitendinosus Muscles as Functional Agonist and Antagonist Muscles
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Botulinum toxin
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring cerebral palsy children, Botulinum toxin
Eligibility Criteria
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
Sites / Locations
- Hôpital Edouard Herriot - Pavillon T bis
Outcomes
Primary Outcome Measures
Clinical evaluation of the passive range of motion of the lower limbs
Secondary Outcome Measures
Evaluation of the spasticity using Tardieu Scale, Ashworth Scale and Ely test
Evaluation of functional outcome using Gross Motor Function Measure and Gillette Functional Assessment, subjective evaluation, physiological cost index
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00133861
Brief Title
Botulinum Toxin Efficiency on Spasticity of Rectus Femoris and Semitendinosus Muscles as Functional Agonist and Antagonist Muscles
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
cerebral palsy children, Botulinum toxin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin
Primary Outcome Measure Information:
Title
Clinical evaluation of the passive range of motion of the lower limbs
Secondary Outcome Measure Information:
Title
Evaluation of the spasticity using Tardieu Scale, Ashworth Scale and Ely test
Title
Evaluation of functional outcome using Gross Motor Function Measure and Gillette Functional Assessment, subjective evaluation, physiological cost index
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno DOHIN, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Edouard Herriot - Pavillon T bis
City
Lyon
ZIP/Postal Code
69003
Country
France
12. IPD Sharing Statement
Learn more about this trial
Botulinum Toxin Efficiency on Spasticity of Rectus Femoris and Semitendinosus Muscles as Functional Agonist and Antagonist Muscles
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