Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-30 @ 6:22 PM
Study NCT ID:
NCT00133861
Status:
COMPLETED
Last Update Posted:
2025-12-19
First Post:
2005-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Botulinum Toxin Efficiency on Spasticity of Rectus Femoris and Semitendinosus Muscles as Functional Agonist and Antagonist Muscles
Sponsor:
Hospices Civils de Lyon
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: