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

This study has been completed.
Sponsor:
Collaborator:
Bobath Memorial Hospital
Information provided by (Responsible Party):
Sun Im, The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01278576
First received: January 10, 2011
Last updated: May 14, 2012
Last verified: January 2011
  Purpose

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 Intervention Phase
Muscle Spasticity
Stroke
Drug: BOTOX-A®
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • Change from baseline for EMG (electromyogram) activity [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    Surface EMG


Secondary Outcome Measures:
  • Change from baseline of GCM tone a measured on the Modified Ashworth Scale (MAS) [ Time Frame: Change from baseline at 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline of Ankle Range of motion [ Time Frame: Change from baseline at 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from baseline at 8 weeks ] [ Designated as safety issue: No ]
    Change from baseline at 8 weeks

  • Change from baseline of ABILOCO scale [ Time Frame: Change from baseline at 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline of Disability Assessment Scale [ Time Frame: Change from baseline at 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline of Functional Ambulation Category Scale [ Time Frame: Change from baseline at 8 weeks ] [ Designated as safety issue: No ]
  • Change of baseline of Lindmark Modified Fugyl Meyer Scale [ Time Frame: Change from baseline at 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline of Tardieu angle of ankle [ Time Frame: Change from baseline at 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: January 2011
Study Completion Date: May 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01278576

Locations
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
Investigators
Principal Investigator: Sun Im, MD, PhD Department of Rehabilitation Medicine, Bucheon St Mary's Hospital, Catholic University of Korea, College of Medicine
  More Information

No publications provided

Responsible Party: Sun Im, Assistant Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01278576     History of Changes
Other Study ID Numbers: BCMC10AH07
Study First Received: January 10, 2011
Last Updated: May 14, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by The Catholic University of Korea:
Muscle spasticity
Stroke
Botulinum Toxins
Lower extremity
Ankle

Additional relevant MeSH terms:
Muscle Spasticity
Stroke
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014