HEMITOX : Effect of Botulinum Toxin Injections on Motor and Functional Ability of Upper Limb in Adults at Earlier Phases of Spastic Hemiplegia After Stroke

January 18, 2011 updated by: University Hospital, Clermont-Ferrand

Effect of Botulinum Toxin Injections on Motor and Functional Ability of Upper Limb in Adults at Earlier Phases of Spastic Hemiplegia After Stroke

Botulinum toxin produced beneficial effects in spasticity in the hemiplegic upper limb. This study will test if botulinum toxin injections at earlier phases (<or = 3 months) in spasticity improve functional and motor tests compared with late injections (>or = 6 months).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Auvergne
      • Clermont-Ferrand, Auvergne, France, 63000
        • Recruiting
        • Clermont-Ferrand University Hospital
        • Contact:
          • Franck Durif
          • Phone Number: (33) 04 73 750 750

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Minimum age 18
  • Spastic hemiplegia after ischemic stroke (carotid occlusion) within the past 3 months.
  • Antispasticity medication stabilized for the last 30 days
  • Severe cognitive impairment such that patient is unable to provide scale assessment.
  • Significant spasticity impeding improvement by re-education for 2 months or less

  • Lack of muscular retraction defined by a minimal range of articular motion as :

    • finger : complete extension and rolling up
    • wrist : extension 40°/flexion : 45°
    • elbow : extension - 10°/flexion : 120°
    • shoulder : Enjalbert score 2 or more
  • Antagonist muscles (to spasticity) activity score 1 or more
  • Social Security benefits

Exclusion Criteria:

  • Ischemic stroke thought to be due to basilar or vertebral vessel occlusion
  • Known motor neuron or neuromuscular junction disease, disorders in which pain limits the ability to inject muscles (algodystrophy)
  • Absence of mobility in proximal part of upper limb that does not predict a functional gain
  • Minor stroke with non-disabling deficit or rapidly improving motor symptoms
  • other serious illness, e.g. severe hepatic, cardiac, or renal failure ; acute myocardial infarction ; or a complex disease that may confound treatment assessment
  • Treatment of spasticity by previous administration of botulinum toxin, if known
  • Known allergy to botulinum toxin
  • Currently participating in other research studies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Clinical Global Impression (CGI)
Deficiency, incapacity, handicap : Frenchay Arm test(post stroke arm function); Enjalbert test;
Box and blocks test
Enjalbert test
Modified Ashworth scale (upper limb)
Functional Independence Measure
Fugl-Meyer upper limb test
36-Item Short Form (SF-36) quality of life

Secondary Outcome Measures

Outcome Measure
Range of pain
Individual functional kinesitherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Centre Hospitalier Universitaire de Saint Etienne
Centre Hospitalier Universitaire de Besancon
Rennes University Hospital
J. Rebeyrol Hospital in Limoges
Center of Physical Medicine and Rehabilitation (Notre Dame de Lourdes Center in Rennes)
Saint Jacques Hospital in Nantes
Centre Régional de Département de médecine physique et réadaptation CHU-C3RF in Angers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Anticipated)

January 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

January 12, 2006

First Submitted That Met QC Criteria

January 12, 2006

First Posted (Estimate)

January 13, 2006

Study Record Updates

Last Update Posted (Estimate)

January 19, 2011

Last Update Submitted That Met QC Criteria

January 18, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU63-0003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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