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Dejerine-Klumpke Palsy |
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Clinical Trial: Botulinum Toxin Efficiency on Spasticity of Rectus Femoris and Semitendinosus Muscles as Functional Agonist and Antagonist Muscles.
This study is currently recruiting patients.
Verified by Hospices Civils de Lyon August 2005
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Purpose
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 rectus femoris and semitendinosus and the treatment is botulinum toxin. Clinical assessment (passive range of motion of the lower limbs, spasticity level, functional scales et subjective feeling) and gait analysis data (kinematics and kinetics data) are collected. Evaluations take place before treatment, 2 months and 6 month after treatment.
| Condition | Intervention | Phase |
|---|---|---|
| Cerebral palsy children | Drug: Botulinum toxin | Phase II Phase III |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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.
Further Study Details:
Primary Outcomes: Clinical evaluation of the passive range of motion of the lower limbs
Secondary Outcomes: Evaluation of the spasticity using Tardieu scale, Aschworth scale and Ely-test; Evaluation of functional outcome using Gross Motor Function Measure and Gillette Functional Assessment, subjective evaluation, Physiological cost index.
Expected Total Enrollment: 23
Secondary Outcomes: Evaluation of the spasticity using Tardieu scale, Aschworth scale and Ely-test; Evaluation of functional outcome using Gross Motor Function Measure and Gillette Functional Assessment, subjective evaluation, Physiological cost index.
Expected Total Enrollment: 23
Eligibility
Ages Eligible for Study: 7 Years - 17 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Patients between 7 to 17 years old
- Cerebral palsy children with walking ability (even with crutch or kee-walker) allowing gait analysis.
- Patients with functional status allowing the use of botulinum toxin on target muscles.
Exclusion Criteria:
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00133861
Bruno DOHIN, MD 33 472 110 Ext. 464 bruno.dohin@chu-lyon.fr
France
Hôpital Edouard Herriot - Pavillon T bis, Lyon, 69003, France; Recruiting
Bruno DOHIN, MD 33 472 110 Ext. 464 bruno.dohin@chu-lyon.fr
Bruno DOHIN, MD, Principal Investigator
Bruno DOHIN, MD, Principal Investigator
Study chairs or principal investigators
Bruno DOHIN, MD, Principal Investigator, Hospices Civils de Lyon
More Information
Study ID Numbers: 2004.351
Last Updated: August 23, 2005
Record first received: August 23, 2005
ClinicalTrials.gov Identifier: NCT00133861
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-08-30
Last Updated: August 23, 2005
Record first received: August 23, 2005
ClinicalTrials.gov Identifier: NCT00133861
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-08-30
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