The Effectiveness of Early Botulinum Toxin A Injection for Lower Limbs Spasticity in Subacute Stroke Adults

NCT02505802 | Unknown Phase 4 DMC

• 1 other identifier: 2013KYB163
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Botulinum toxin A (BoNT-A) injections are widely used to treat spasticity after stroke. Although this treatment is effective on muscle tone improvement, its effect on gait and ability of daily living on early stage of stroke adults remains uncertain.The purpose of this study is to determine whether an early calf muscle injection of low dose BoNT-A in severely affected patients within 6 weeks after stroke could help to hold back disabling muscle spasticity and improve walking dysfunction.

Conditions

Stroke; Muscle Spasticity

Keywords

Stroke; Botulinum Toxins; Muscle Spasticity; Gait

Outcome Measures

Primary Outcomes (1)

• Change from baseline of Calf muscle modified Ashworth scale assess (MAS)

  The outcome will be undertaken at weeks 0 (baseline), 8, 12 and 24 weeks later

Secondary Outcomes (4)

• Lower limbs Fugl-Meyer (FM) score

  The outcome will be undertaken at weeks 0 (baseline), 8, 12 and 24 weeks later

• Average integrated sEMG levels of gastrocnemius

  The outcome will be undertaken at weeks 0 (baseline), 8, 12 and 24 weeks later

• 6-min walking distance

  The outcome will be were assessed 8, 12, 24 weeks after injection.

• Gait analysis (step length，cadence，speed).

  The outcome will be undertaken at weeks 0 (baseline), 8, 12 and 24 weeks later

Study Arms (2)

BoNT-A treatment group

EXPERIMENTAL

In BoNT-A treatment group patients received 200 units BoNT-A injection in the triceps surae (150iu) and tibial muscle posterior (50iu). Both groups received comprehensive rehabilitation for 8 weeks.

Drug: BoNT-A injection

Control group

NO INTERVENTION

No special treatment was performed in the control group. Both groups received comprehensive rehabilitation for 8 weeks.

Interventions

BoNT-A injection DRUG

In BoNT-A treatment group patients received 200 units BoNT-A injection in the triceps surae (150iu) and tibial muscle posterior (50iu).

Also known as: Botulinum toxin A

BoNT-A treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Were over the age of 18 and less than 80 years and had a stroke within 6 weeks.
• Had slight spasticity of the triceps surae as defined by a score of 1-1+ on the Modified Ashworth Scale (MAS) or ankle clonus (+).
• Had sufficient cognitive and communication ability as defined by MMSE (mini-mental state examination)\>25.
• Couldn't dorsiflex ankle and their LEMI (Lower Extremity Motor Index) \< 10.
• Were not receiving concurrent aminoglycoside antibiotics and oral anti-spasticity medication

You may not qualify if:

• Known allergy or sensitivity to study medication or its components.
• Infection or dermatological condition at the injection sites.
• Any medical condition that may put the subject at increased risk with exposure , including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disorder that might have interfered with neuromuscular function.
• QTc criteria: QTc ≥ 450 millisecond (msec) or≥480msec for subjects with Bundle Branch Block-values based on either single electrocardiogram (ECG) values or triplicate ECG averaged QTc values obtained over a brief recording period
• Liver function tests: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥2xULN; alkaline phosphatase and bilirubin \>1.5xULN (isolated bilirubin \>1.5ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
• Concurrent use of aminoglycoside antibiotics or other agents that might interfere with neuromuscular function.
• Patients with severe cognitive impairment or neurological diseases affecting the implementation or evaluation of the test, and drug-dependent patients.
• Presence of clinically unstable severe cardiovascular, renal or respiratory disease
• Researchers believe there are other factors unfit to participate in this study of patients.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (1)

Sir Run Run Shaw Hospital, Medical College of Zhejiang University

Hangzhou, Zhejiang, 310016, China

RECRUITING

Related Publications (6)

• Lundstrom E, Terent A, Borg J. Prevalence of disabling spasticity 1 year after first-ever stroke. Eur J Neurol. 2008 Jun;15(6):533-9. doi: 10.1111/j.1468-1331.2008.02114.x. Epub 2008 Mar 18.

  PMID: 18355307 RESULT

• Sommerfeld DK, Eek EU, Svensson AK, Holmqvist LW, von Arbin MH. Spasticity after stroke: its occurrence and association with motor impairments and activity limitations. Stroke. 2004 Jan;35(1):134-9. doi: 10.1161/01.STR.0000105386.05173.5E. Epub 2003 Dec 18.

  PMID: 14684785 RESULT

• McIntyre A, Lee T, Janzen S, Mays R, Mehta S, Teasell R. Systematic review of the effectiveness of pharmacological interventions in the treatment of spasticity of the hemiparetic lower extremity more than six months post stroke. Top Stroke Rehabil. 2012 Nov-Dec;19(6):479-90. doi: 10.1310/tsr1906-479.

  PMID: 23192713 RESULT

• Kaji R, Osako Y, Suyama K, Maeda T, Uechi Y, Iwasaki M; GSK1358820 Spasticity Study Group. Botulinum toxin type A in post-stroke lower limb spasticity: a multicenter, double-blind, placebo-controlled trial. J Neurol. 2010 Aug;257(8):1330-7. doi: 10.1007/s00415-010-5526-3. Epub 2010 Apr 1.

  PMID: 20358216 RESULT

• Cosgrove AP, Graham HK. Botulinum toxin A prevents the development of contractures in the hereditary spastic mouse. Dev Med Child Neurol. 1994 May;36(5):379-85. doi: 10.1111/j.1469-8749.1994.tb11863.x.

  PMID: 8168656 RESULT

• Santamato A, Micello MF, Panza F, Fortunato F, Pilotto A, Giustini A, Testa A, Fiore P, Ranieri M, Spidalieri R. Safety and efficacy of incobotulinum toxin type A (NT 201-Xeomin) for the treatment of post-stroke lower limb spasticity: a prospective open-label study. Eur J Phys Rehabil Med. 2013 Aug;49(4):483-9. Epub 2013 Mar 13.

  PMID: 23480980 RESULT

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Interventions

incobotulinumtoxinA; Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• TAO WU, MD

  Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University

  STUDY DIRECTOR

Central Study Contacts

TAO WU, MD

CONTACT

86 571 86006054; wutao1880@163.com

JIANHUA LI, MD

CONTACT

86 571 86006054; zjdxsyfkfk@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 17, 2015
• First Posted: July 22, 2015
• Study Start: January 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: July 22, 2015

Record last verified: 2015-07

Locations

CN (1)