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

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ClinicalTrials.gov Identifier: NCT01817816
Recruitment Status : Completed
First Posted : March 25, 2013
Last Update Posted : November 5, 2015
Sponsor:
Information provided by (Responsible Party):
Ta-Sen Wei,MD, Changhua Christian Hospital

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Stroke Spasticity Procedure: Botox_A Procedure: Botox_B Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : January 2009
Actual Primary Completion Date : April 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in the gait pattern as walking [ Time Frame: 4 weeks after intervention ]

Eligibility Criteria
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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01817816


Locations
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Taiwan
Changhua Christian Hospital
Taiwan, Changhua, Taiwan, 500
Sponsors and Collaborators
Changhua Christian Hospital
More Information
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Responsible Party: Ta-Sen Wei,MD, Director, Physical Medical and Rehabilitation, Principal Investigator, Clinical Professor, Changhua Christian Hospital
ClinicalTrials.gov Identifier: NCT01817816    
Other Study ID Numbers: CCH-061203
First Posted: March 25, 2013    Key Record Dates
Last Update Posted: November 5, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Botulinum Toxins, Type A
abobotulinumtoxinA
 Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents