Early Injection of Botulinum Toxin on Motor Function and Gait Pattern in Stroke Patients

November 3, 2015 updated by: Ta-Sen Wei,MD, Changhua Christian Hospital

Spasticity, muscle weakness, abnormal gait pattern are co-morbidities commonly seen in stroke patients. They cause disabled condition of patients in activities of daily life and functional performance, and also accidental falls and subsequent fractures.

This study is to evaluate and compare the effects of different phase injection of Botulinum Toxin Type-A at affected limbs on muscle rheological changes, muscle activity, muscle tone, functional performance, gait pattern and energy consumption in stroke patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

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

  • Taiwan
    • Changhua
      • Taiwan, Changhua, Taiwan, 500
        • Changhua Christian Hospital

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

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • first-ever stroke, with spasticity within 3-months (MAS=2~3)
  • independent walking 10 meters (with assistive devices)

Exclusion Criteria:

  • recurrent stroke, cognition impaired
  • lower limb fracture
  • received anti-spasticity injection in the past

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Botox_A
receiving Botulinum Toxin Type-A (Botox-A, Allergan) at both affected lower extremity (aLE) and upper extremity (aUE)
Procedure: Botox_A
Placebo Comparator: placebo_A
receiving placebo injection at both aLE & aUE ; receiving Botox-A at both aLE & aUE at 6-month.
Procedure: Botox_A
Experimental: Botox_B
receiving Botox-A injection at aLE and placebo injection (sterile normal saline) at aUE.
Procedure: Botox_B
Placebo Comparator: placebo_B
receiving placebo injection at both aLE & aUE ; receiving Botox-A only at aLE at 6-month.
Procedure: Botox_B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the muscle tone in upper and lower extremity
Time Frame: 4 weeks after injection

use modified Ashworth Scale to access elbow, wrist, ankle joint muscle tone 0: normal

  1. slight hypertonus, at the end-range 1+: mild hypertonus, catch when limb is moved (<1/2)
  2. moderate hypertonus,, limbs moves easily (>1/2)
  3. passive movement difficult
  4. rigid
4 weeks after injection

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in the gait pattern as walking
Time Frame: 4 weeks after intervention
4 weeks after intervention

Collaborators and Investigators

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

Sponsor

Changhua Christian Hospital

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

January 1, 2009

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

March 21, 2013

First Submitted That Met QC Criteria

March 21, 2013

First Posted (Estimate)

March 25, 2013

Study Record Updates

Last Update Posted (Estimate)

November 5, 2015

Last Update Submitted That Met QC Criteria

November 3, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCH-061203

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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