NCT03405948

Brief Summary

Botulinum toxin is the main treatment for focal spasticity but the effects of botulinum toxin injections with respect to limitations of gait activities are still discussed. The aim of this study is to to investigate the effects of intramuscular Botulinum toxin type A injections on quantitative gait parameters (gait speed, step length and width, single support time) and posture, in hemiparetic post stroke patients with lower limb spasticity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 19, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2009

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2010

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
Last Updated

January 23, 2018

Status Verified

October 1, 2017

Enrollment Period

3 years

First QC Date

October 31, 2017

Last Update Submit

January 19, 2018

Conditions

Spastic Equinovarus Foot

Outcome Measures

Primary Outcomes (1)

  • Posture

    sway area of the center of pressure measured with AMTI® force plate

    6 weeks after injection

Secondary Outcomes (1)

  • Gait

    6 weeks after injection

Study Arms (2)

botulinum toxin

EXPERIMENTAL

injection of Botulinum toxin

Drug: Intra muscular injection of Botulinum toxin

placebo

PLACEBO COMPARATOR

Injection of saline serum (placebo)

Drug: Intra muscular injection of Botulinum toxin

Interventions

Intra muscular injection of Botulinum toxinDRUG

posture and gait analysis were performed before injection and 4 to 6 weeks after injection

botulinum toxinplacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic stroke hemiplegic patients presenting lower limb spasticity
  • A minimum 12-month interval since stroke,
  • Lower limb spasticity with a Modified Ashworth Scale greater than or equal to 2 on the triceps surae
  • Minimum 6-month interval since a previous BTx-A injection
  • To be older than 18 years.
  • Patients must have an indication of treatment with Botulinum toxin, determined by a Physical and Rehabilitation Medicine specialist, based on clinical examination and gait analysis

You may not qualify if:

  • Contraindication to the use of botulinum toxin: Myastenia, Lambert Eaton syndrome, ALS, pregnancy, breast-feeding, treatment with aminoglycoside, cyclosporine, previous hypersensitivity to botulinum toxin
  • Contraindication to intramuscular injections
  • Patients unable to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital de la Timone Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

Location

Related Publications (1)

  • Kerzoncuf M, Viton JM, Pellas F, Cotinat M, Calmels P, Milhe de Bovis V, Delarque A, Bensoussan L. Poststroke Postural Sway Improved by Botulinum Toxin: A Multicenter Randomized Double-blind Controlled Trial. Arch Phys Med Rehabil. 2020 Feb;101(2):242-248. doi: 10.1016/j.apmr.2019.04.024. Epub 2019 Aug 27.

    PMID: 31469982DERIVED

Study Officials

  • Urielle DESALBRES

    Assistance Publique des Hôpitaux de Marseille

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2017

First Posted

January 23, 2018

Study Start

May 19, 2006

Primary Completion

May 18, 2009

Study Completion

November 17, 2010

Last Updated

January 23, 2018

Record last verified: 2017-10

Locations

FR(1)