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

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ClinicalTrials.gov Identifier: NCT01278576
Recruitment Status : Completed
First Posted : January 19, 2011
Last Update Posted : May 15, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Muscle Spasticity Stroke Drug: BOTOX-A® Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2011
Primary Completion Date : December 2011
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Intramuscular ending Targeting
Botox 200 units placed at the upper 2/10-3/10 length of the GCM
Drug: BOTOX-A®
200 units, single treatment only
Other Name: Generic Name: Botulinum toxin type A
Active Comparator: Midbelly Targeting
A total of 200 units will be placed at the four quadrants of the midbelly portion of the GCM.
Drug: BOTOX-A®
200 units, single treatment only
Other Name: Generic Name: Botulinum toxin type A

Outcome Measures

Primary Outcome Measures :
  1. Change from baseline for EMG (electromyogram) activity [ Time Frame: week 8 ]
    Surface EMG

Secondary Outcome Measures :
  1. Change from baseline of GCM tone a measured on the Modified Ashworth Scale (MAS) [ Time Frame: Change from baseline at 8 weeks ]
  2. Change from baseline of Ankle Range of motion [ Time Frame: Change from baseline at 8 weeks ]
    Passive range of motion of the ankle at resting state with the use of goniometer

  3. Change from baseline of gait speed with 10 meters walk test [ Time Frame: Change from baseline at 8 weeks ]
    Change from baseline at 8 weeks

  4. Change from baseline of ABILOCO scale [ Time Frame: Change from baseline at 8 weeks ]
  5. Change from baseline of Disability Assessment Scale [ Time Frame: Change from baseline at 8 weeks ]
  6. Change from baseline of Functional Ambulation Category Scale [ Time Frame: Change from baseline at 8 weeks ]
  7. Change of baseline of Lindmark Modified Fugyl Meyer Scale [ Time Frame: Change from baseline at 8 weeks ]
  8. Change from baseline of Tardieu angle of ankle [ Time Frame: Change from baseline at 8 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

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): NCT01278576

Korea, Republic of
Department of Rehabilitation Medicine Bucheon St Mary's Hospital, Catholic University of Korea, College of Medicine
Bucheon, Kyounggido, Korea, Republic of
Bobath Memorial Hospital
Songnam, Kyoungido, Korea, Republic of
Sponsors and Collaborators
The Catholic University of Korea
Bobath Memorial Hospital
Principal Investigator: Sun Im, MD, PhD Department of Rehabilitation Medicine, Bucheon St Mary's Hospital, Catholic University of Korea, College of Medicine
More Information

Responsible Party: Sun Im, Assistant Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01278576     History of Changes
Other Study ID Numbers: BCMC10AH07
First Posted: January 19, 2011    Key Record Dates
Last Update Posted: May 15, 2012
Last Verified: January 2011

Keywords provided by Sun Im, The Catholic University of Korea:
Muscle spasticity
Botulinum Toxins
Lower extremity

Additional relevant MeSH terms:
Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents