Botulinum Toxin Efficiency on Spasticity of Rectus Femori... | NCT00133861

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

NCT00133861

Sponsor

Hospices Civils de Lyon

Status

Completed

Last Update Posted

Dec 19, 2025Actual

Enrollment

23Estimated

Phase

Phase 2Phase 3

Conditions

Cerebral Palsy

Interventions

Botulinum toxin

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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 Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2005

Primary Completion Date

Jun 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Aug 23, 2005

First Submission Date that Met QC Criteria

Aug 23, 2005

First Posted Date

Aug 24, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 13, 2025

Last Update Posted Date

Dec 19, 2025Actual

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Estimated

Name	Type	Description	Arm Group Labels	Other Names
Botulinum toxin	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical evaluation of the passive range of motion of the lower limbs

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bruno DOHIN, MD	Hospices Civils de Lyon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Edouard Herriot - Pavillon T bis		Lyon		69003	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18065878	Result	Dohin B, Garin C, Vanhems P, Kohler R. [Botulinum toxin for postoperative care after limb surgery in cerebral palsy children]. Rev Chir Orthop Reparatrice Appar Mot. 2007 Nov;93(7):674-81. doi: 10.1016/s0035-1040(07)73252-x. French.

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D008666	Metalloendopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases
D006867	Hydrolases