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Botulinum Toxin A Adult Gastrocnemius Muscle Study (BTX-A)

Primary Purpose

Muscle Spasticity, Stroke

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
BOTOX-A®
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Spasticity focused on measuring Muscle spasticity, Stroke, Botulinum Toxins, Lower extremity, Ankle

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female, 20 < age < 70 year old
  • Hemiplegia documented after ischemic or hemorrhagic stroke, documented by CT (computed tomography) or MRI (magnetic resonance imaging) scan
  • Time between the onset of stroke < 24 months
  • Individuals who have been medically stable for at least 4 weeks prior to study enrollment
  • Confirmed equinovarus with spastic hypertonia of the ankle
  • Spasticity as defined by a MAS greater than grade 1 +
  • Botulinum toxin -naive patients
  • Participants who can complete the 10 meter walking test with caregiver or walking tool assistance within 8 and 45 seconds, on 2 occasions
  • Participants who will have stable treatment regimen and concomitant medication during the trial period

Exclusion Criteria:

  • The patient has any of the following medical conditions that is contraindication to botulinum toxin exposure; pregnancy, lactation, neuromuscular disease, aminoglycoside, antibiotic concurrent to botulinum toxin treatment
  • Fixed contracture of the ankle, previous history of surgical procedure performed on the ankle
  • Cognitive deficit that disables patients to give informed consent to the procedure
  • Concomitant progression of any CNS (central nervous system) or PNS (peripheral nervous system), or myopathy, or uncontrolled seizure. Underlying CNS insult should be controlled and in stable condition with no further risk of progression and further deterioration of patient's current neurological status. Those with multiple sclerosis or multiple systemic atrophy are to be excluded
  • Significant cutaneous or joint inflammation
  • URI or other systemic infection that would mandate the use of antibiotic concurrent to botulinum toxin injection
  • Anticoagulation treatment with INR (International Normalized Ratio) greater than 3.0
  • Upper extremity spasticity greater than MAS grade 4 that may limit gait function
  • Subjects with previous episodes of motor point block injection using phenol or other chemodenervating agents
  • Subjects with intrathecal baclofen pump

Sites / Locations

  • Department of Rehabilitation Medicine Bucheon St Mary's Hospital, Catholic University of Korea, College of Medicine
  • Bobath Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intramuscular ending Targeting

Midbelly Targeting

Arm Description

Botox 200 units placed at the upper 2/10-3/10 length of the GCM

A total of 200 units will be placed at the four quadrants of the midbelly portion of the GCM.

Outcomes

Primary Outcome Measures

Change from baseline for EMG (electromyogram) activity
Surface EMG

Secondary Outcome Measures

Change from baseline of GCM tone a measured on the Modified Ashworth Scale (MAS)
Change from baseline of Ankle Range of motion
Passive range of motion of the ankle at resting state with the use of goniometer
Change from baseline of gait speed with 10 meters walk test
Change from baseline at 8 weeks
Change from baseline of ABILOCO scale
Change from baseline of Disability Assessment Scale
Change from baseline of Functional Ambulation Category Scale
Change of baseline of Lindmark Modified Fugyl Meyer Scale
Change from baseline of Tardieu angle of ankle

Full Information

First Posted
January 10, 2011
Last Updated
May 14, 2012
Sponsor
The Catholic University of Korea
Collaborators
Bobath Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01278576
Brief Title
Botulinum Toxin A Adult Gastrocnemius Muscle Study
Acronym
BTX-A
Official Title
An Efficacy Comparison of Botulinum Toxin A Injection Into Two Different Sites in Gastrocnemius Muscle for the Treatment of Spastic Patients, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea
Collaborators
Bobath Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study aims to compare the effectiveness of BOTOX-A® (botulinun toxin A) placed between two different injection sites, namely at the proximal portion of the gastrocnemius(GCM) versus at the midbelly of the GCM.
Detailed Description
Previous studies have used the midbelly of a muscle as the position where the motor endplates are most densely located. The reasoning behind this method was based on the previous works that showed most bands of cholinesterase activity to be located in specific topographical patterns at the center of the muscle fiber. These results have been used as landmarks to place the injections. Current standard guidelines recommend that botulinum toxin be placed at the 4 quadrants of the midbelly portion of the gastrocnemius (GCM) muscle. However, recent cadaveric research studies on the distribution of the intramuscular endings of the GCM suggest that the highest branch density is found within the upper 20-30% length of the calf. Therefore, in accordance to the theory that effect of botulinum toxin are greatest at sites where the intramuscular endings are most dense, the location where these toxins should be placed would be at these proximal sites of the GCM rather than at the midbelly. 40 recruited patients will be allocated into either the intramuscular ending targeted (ie.upper portion of calf) or midbelly targeted group. Each subject will undergo a total number of 4 assessments; prior to the injection and 2,4and 8 weeks post injection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Spasticity, Stroke
Keywords
Muscle spasticity, Stroke, Botulinum Toxins, Lower extremity, Ankle

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intramuscular ending Targeting
Arm Type
Experimental
Arm Description
Botox 200 units placed at the upper 2/10-3/10 length of the GCM
Arm Title
Midbelly Targeting
Arm Type
Active Comparator
Arm Description
A total of 200 units will be placed at the four quadrants of the midbelly portion of the GCM.
Intervention Type
Drug
Intervention Name(s)
BOTOX-A®
Other Intervention Name(s)
Generic Name: Botulinum toxin type A
Intervention Description
200 units, single treatment only
Primary Outcome Measure Information:
Title
Change from baseline for EMG (electromyogram) activity
Description
Surface EMG
Time Frame
week 8
Secondary Outcome Measure Information:
Title
Change from baseline of GCM tone a measured on the Modified Ashworth Scale (MAS)
Time Frame
Change from baseline at 8 weeks
Title
Change from baseline of Ankle Range of motion
Description
Passive range of motion of the ankle at resting state with the use of goniometer
Time Frame
Change from baseline at 8 weeks
Title
Change from baseline of gait speed with 10 meters walk test
Description
Change from baseline at 8 weeks
Time Frame
Change from baseline at 8 weeks
Title
Change from baseline of ABILOCO scale
Time Frame
Change from baseline at 8 weeks
Title
Change from baseline of Disability Assessment Scale
Time Frame
Change from baseline at 8 weeks
Title
Change from baseline of Functional Ambulation Category Scale
Time Frame
Change from baseline at 8 weeks
Title
Change of baseline of Lindmark Modified Fugyl Meyer Scale
Time Frame
Change from baseline at 8 weeks
Title
Change from baseline of Tardieu angle of ankle
Time Frame
Change from baseline at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, 20 < age < 70 year old Hemiplegia documented after ischemic or hemorrhagic stroke, documented by CT (computed tomography) or MRI (magnetic resonance imaging) scan Time between the onset of stroke < 24 months Individuals who have been medically stable for at least 4 weeks prior to study enrollment Confirmed equinovarus with spastic hypertonia of the ankle Spasticity as defined by a MAS greater than grade 1 + Botulinum toxin -naive patients Participants who can complete the 10 meter walking test with caregiver or walking tool assistance within 8 and 45 seconds, on 2 occasions Participants who will have stable treatment regimen and concomitant medication during the trial period Exclusion Criteria: The patient has any of the following medical conditions that is contraindication to botulinum toxin exposure; pregnancy, lactation, neuromuscular disease, aminoglycoside, antibiotic concurrent to botulinum toxin treatment Fixed contracture of the ankle, previous history of surgical procedure performed on the ankle Cognitive deficit that disables patients to give informed consent to the procedure Concomitant progression of any CNS (central nervous system) or PNS (peripheral nervous system), or myopathy, or uncontrolled seizure. Underlying CNS insult should be controlled and in stable condition with no further risk of progression and further deterioration of patient's current neurological status. Those with multiple sclerosis or multiple systemic atrophy are to be excluded Significant cutaneous or joint inflammation URI or other systemic infection that would mandate the use of antibiotic concurrent to botulinum toxin injection Anticoagulation treatment with INR (International Normalized Ratio) greater than 3.0 Upper extremity spasticity greater than MAS grade 4 that may limit gait function Subjects with previous episodes of motor point block injection using phenol or other chemodenervating agents Subjects with intrathecal baclofen pump
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun Im, MD, PhD
Organizational Affiliation
Department of Rehabilitation Medicine, Bucheon St Mary's Hospital, Catholic University of Korea, College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rehabilitation Medicine Bucheon St Mary's Hospital, Catholic University of Korea, College of Medicine
City
Bucheon
State/Province
Kyounggido
Country
Korea, Republic of
Facility Name
Bobath Memorial Hospital
City
Songnam
State/Province
Kyoungido
Country
Korea, Republic of

12. IPD Sharing Statement

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Botulinum Toxin A Adult Gastrocnemius Muscle Study

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