Study of the Effect of Botulinum Toxin Injection in Rectus Femoris and Triceps on the Length and the Strength During Locomotion in Chronic Hemiparetic Patients

NCT ID: NCT01821573

Last Updated: 2019-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2019-05-23

Brief Summary

The aim of this randomized controlled study is to quantify the modification during locomotion of chronic hemiparetic patients of the strength and the length of Rectus Femoris and Triceps Surae induced by botulinum toxin injection type A.

The main hypotheses of this study based on previous studies are that botulinum toxin injection increases on one hand the length of the muscle injected during gait and on the other hand decreased the strength of the muscles injected.

The investigators also hypothesized that botulinum toxin injection improved the strength of the antagonist muscles and normalized the pattern of strength of the muscles injected during gait.

Detailed Description

The aim of this study is to compare versus placebo the effects of BTX-A injection on :

• the maximal length of the muscles injected during gait
• the maximal lengthening velocity of the muscles injected during gait
• the maximal strength of muscles injected during gait
• the inter-limb coordination assessed by continuous relative phase
• the kinematic parameters such as peak knee flexion during swing phase of the gait cycle and peak ankle dorsiflexion during stance phase.

To that end each patient included in the study will be assessed before injection, one month after the BTX-A injection and 3 months after BTX-A injections.

All patients will underwent a clinical examination, a 3D gait analysis and a isokinetic dynamometer analysis.

The comparison of the results in the group treated by BTX-A will permit to show that one month after BTX-A injection peak length during gait of muscles injected, maximal lengthening velocity peak knee flexion during swing phase and peak ankle dorsiflexion increase significantly.

It will also permit to show that the maximal strength of muscles injected decreases whereas the strength of antagonist increases It will also permit to demonstrate that multisite BTX-A injection improve coordination of paretic and non paretic lower limb the inter-group comparison will permit to demonstrate that these modification are mainly due to multisite BTX-A injections.

Conditions

COMPARISON BETWEEN GROUP TREATED WITH BOTULINUM TOXIN AND PLACEBO

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Botox Injection

Patients treated by botulinum toxin.

Group Type: EXPERIMENTAL

botulinum toxin type A

Intervention Type: DRUG

Experimental arm group:

• 150 Units in rectus femoris ( 3 ml and 3 points)
• 70 units in medial gastrocnemius (1.4 ml and 1 point)
• 70 units in lateral gastrocnemius ( 1.4 ml and 1 point)
• 60 units in soleus ( 1.2 ml and 3 points)

Saline Solution

Patients treated with saline solution.

Group Type: PLACEBO_COMPARATOR

injection of NaCl 0.9%

Intervention Type: DRUG

Placebo comparator group: injection of NaCl 0.9%:

• 3 ml of NaCl 0.9% in rectus femoris in 3 points
• 1.4 ml of NaCl 0.9% in medial gastrocnemius in 1 point
• 1.4 ml of Nacl 0.9% in lateral gastrocnemius in 1 point
• 1.2 ml of NaCl 0.9% in soleus in 3 points

Interventions

botulinum toxin type A

Experimental arm group:

• 150 Units in rectus femoris ( 3 ml and 3 points)
• 70 units in medial gastrocnemius (1.4 ml and 1 point)
• 70 units in lateral gastrocnemius ( 1.4 ml and 1 point)
• 60 units in soleus ( 1.2 ml and 3 points)

Intervention Type: DRUG

injection of NaCl 0.9%

Placebo comparator group: injection of NaCl 0.9%:

• 3 ml of NaCl 0.9% in rectus femoris in 3 points
• 1.4 ml of NaCl 0.9% in medial gastrocnemius in 1 point
• 1.4 ml of Nacl 0.9% in lateral gastrocnemius in 1 point
• 1.2 ml of NaCl 0.9% in soleus in 3 points

Intervention Type: DRUG

Other Intervention Names

Botox® allergan Inc

Eligibility Criteria

Inclusion Criteria

• men or women aged > 18 ans
• unilateral stroke more than 6 months
• ability to walk 10 meters without assistive device
• decrease of peak knee flexion in swing phase of the gait cycle due to a spasticity of Rectus femoris muscle
• plantarflexion in swing phase of the gait cycle due to a spasticity of the triceps surae
• informed consent approved
• oral contraception

Exclusion Criteria

• Aphasia
• anteriority of lower limb surgery less than 6 months
• underlying disease
• pre-existing neuro-muscular disorders
• pregnancy
• absence of oral contraception
• last botulinum toxin injection < 3months
• hypersensitivity reactions
• co-administration of aminoglycosides

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolas Roche, MD

Role: PRINCIPAL_INVESTIGATOR

Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE, 92380 Garches, France

Locations

Service de médecine physique et réadaptation CHU de Brest

Brest, Brittany Region, France

Nicolas Roche

Garches, Hauts-de-Seine, France

Centre de rééducation de l'ADAPT Montargis

Amilly, Loiret, France

Countries

France

References

Supiot A, Geiger M, Bensmail D, Aegerter P, Pradon D, Roche N. Effect of botulinum toxin injection on length and force of the rectus femoris and triceps surae muscles during locomotion in patients with chronic hemiparesis (FOLOTOX). BMC Neurol. 2018 Aug 2;18(1):104. doi: 10.1186/s12883-018-1110-8.

Reference Type: DERIVED

PMID: 30068305 (View on PubMed)

Other Identifiers

2012-001203-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P110136 / AOM11223

Identifier Type: -

Identifier Source: org_study_id