Botulinum Toxin Efficiency on Spasticity of Rectus Femoris and Semitendinosus Muscles as Functional Agonist and Antagonist Muscles
1 other identifier
interventional
23
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2005
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 23, 2005
CompletedFirst Posted
Study publicly available on registry
August 24, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedDecember 19, 2025
December 1, 2025
3.2 years
August 23, 2005
December 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical evaluation of the passive range of motion of the lower limbs
Secondary Outcomes (2)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Edouard Herriot - Pavillon T bis
Lyon, 69003, France
Related Publications (1)
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.
PMID: 18065878RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bruno DOHIN, MD
Hospices Civils de Lyon
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2005
First Posted
August 24, 2005
Study Start
April 1, 2005
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
December 19, 2025
Record last verified: 2025-12