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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

January 10, 2011
May 14, 2012
January 2011
December 2011   (final data collection date for primary outcome measure)
Change from baseline for EMG (electromyogram) activity [ Time Frame: week 8 ] [ Designated as safety issue: No ]
Surface EMG
Change from baseline for EMG activity [ Time Frame: week 8 ] [ Designated as safety issue: No ]
Surface EMG at gastrocnmeus muscle and Tibialis anterior muscle
Complete list of historical versions of study NCT01278576 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Change from baseline of GCM tone a measured on the Modified Ashworth Scale (MAS) [ Time Frame: Day 0, week 2,week 4 and week 8 ] [ Designated as safety issue: No ]
  • Change from baseline of Ankle Range of motion [ Time Frame: Day 0, week 2,week 4 and week 8 ] [ 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: Day 0, week 2,week 4 and week 8 ] [ Designated as safety issue: No ]
  • Change from baseline of ABILOCO scale [ Time Frame: Day 0, week 2,week 4 and week 8 ] [ Designated as safety issue: No ]
  • Change from baseline of Disability Assessment Scale [ Time Frame: Day 0, week 2,week 4 and week 8 ] [ Designated as safety issue: No ]
  • Change from baseline of Functional Ambulation Category Scale [ Time Frame: Day 0, week 2,week 4 and week 8 ] [ Designated as safety issue: No ]
  • Change of baseline of Lindmark Modified Fugyl Meyer Scale [ Time Frame: Day 0, week 2,week 4 and week 8 ] [ Designated as safety issue: No ]
  • Change from baseline of Tardieu angle of ankle [ Time Frame: Day 0, week 2,week 4 and week 8 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Botulinum Toxin A Adult Gastrocnemius Muscle Study
An Efficacy Comparison of Botulinum Toxin A Injection Into Two Different Sites in Gastrocnemius Muscle for the Treatment of Spastic Patients, Randomized Controlled Trial

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Muscle Spasticity
  • Stroke
Drug: BOTOX-A®
200 units, single treatment only
Other Name: Generic Name: Botulinum toxin type A
  • Experimental: Intramuscular ending Targeting
    Botox 200 units placed at the upper 2/10-3/10 length of the GCM
    Intervention: Drug: BOTOX-A®
  • Active Comparator: Midbelly Targeting
    A total of 200 units will be placed at the four quadrants of the midbelly portion of the GCM.
    Intervention: Drug: BOTOX-A®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
May 2012
December 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01278576
BCMC10AH07
Yes
Sun Im, The Catholic University of Korea
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
The Catholic University of Korea
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP