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

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ClinicalTrials.gov Identifier: NCT02505802
Recruitment Status : Unknown
Verified July 2015 by TAO WU, Sir Run Run Shaw Hospital.
Recruitment status was:  Recruiting
First Posted : July 22, 2015
Last Update Posted : July 22, 2015
Sponsor:
Information provided by (Responsible Party):
TAO WU, Sir Run Run Shaw Hospital

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.

Condition or disease Intervention/treatment Phase
Stroke Muscle Spasticity Drug: BoNT-A injection Phase 4

Detailed Description:

The high prevalence of stroke is a global problem causing well-known long-term disabilities. Post-stroke lower-extremity spasticity may cause severe functional limitations and pain. Spasticity is a phenomenon defined as disordered sensory-motor control, resulting from upper motor neuron (UMN) lesion, presenting as intermittent or sustained involuntary activation of muscles . Spasticity may interfere with motor function, and is a common reason for clinical interventions such as by physiotherapy, use of orthoses or other technical devices or drugs. Botulinum toxin A (BoNT-A) is a potent neurotoxin that is produced by the bacterium clostridium botulinum. BoNT-A, by blocking acetylcholine release at neuromuscular junctions, accounts for its therapeutic action to relieve dystonia, spasticity, and related disorders.

Unfortunately, intramuscular injections of botulinum often carried out when the patients have obvious spasticity . It is normally given until the clinical signs of an elevated muscle tone have become established; therefore it is usually given at least three months after stroke , . It will impede the rehabilitation of the patients. Accordingly, the present study asked 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 along 24 weeks fellow up trail.

This is a randomized, open-label, controlled trial along 24-weeks trails. Referred sample of adult subacute stroke patients (within 6 weeks since stroke, n=30) with mild spasticity of calf muscle will be included. Patients were randomly allocated to BoNT-A treatment group (15 patients) and control group (15 patients). In BoNT-A treatment group patients received 200 units BoNT-A injection in the triceps surae (150iu) and tibial muscle posterior (50iu). No special treatment was performed in the control group. Both groups received comprehensive rehabilitation for 8 weeks. Lower limbs Fugl-Meyer (FM) score, calf muscle modified Ashworth scale assess (MAS), gastrocnemius surface electromyography (sEMG) evaluation and modified Barthel index (MBI) were assessed before and 8, 12, 24 weeks after treatment. Gait analysis (step length,cadence,speed), 6-min walking distance were assessed 8, 12, 24 weeks after injection.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III Study of Botulinum Toxin A Injection for Lower Limbs Spasticity in Subacute Stroke Adults
Study Start Date : January 2014
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: BoNT-A treatment group
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
In BoNT-A treatment group patients received 200 units BoNT-A injection in the triceps surae (150iu) and tibial muscle posterior (50iu).
Other Name: Botulinum toxin A

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



Primary Outcome Measures :
  1. Change from baseline of Calf muscle modified Ashworth scale assess (MAS) [ Time Frame: The outcome will be undertaken at weeks 0 (baseline), 8, 12 and 24 weeks later ]

Secondary Outcome Measures :
  1. Lower limbs Fugl-Meyer (FM) score [ Time Frame: The outcome will be undertaken at weeks 0 (baseline), 8, 12 and 24 weeks later ]
  2. Average integrated sEMG levels of gastrocnemius [ Time Frame: The outcome will be undertaken at weeks 0 (baseline), 8, 12 and 24 weeks later ]
    Average integrated surface electromyography (sEMG) levels of gastrocnemius during the slow passive dorsiflexion of the ankle.

  3. 6-min walking distance [ Time Frame: The outcome will be were assessed 8, 12, 24 weeks after injection. ]
  4. Gait analysis (step length,cadence,speed). [ Time Frame: The outcome will be undertaken at weeks 0 (baseline), 8, 12 and 24 weeks later ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Known allergy or sensitivity to study medication or its components.
  2. Infection or dermatological condition at the injection sites.
  3. 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.
  4. 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
  5. 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%).
  6. Concurrent use of aminoglycoside antibiotics or other agents that might interfere with neuromuscular function.
  7. Patients with severe cognitive impairment or neurological diseases affecting the implementation or evaluation of the test, and drug-dependent patients.
  8. Presence of clinically unstable severe cardiovascular, renal or respiratory disease
  9. Researchers believe there are other factors unfit to participate in this study of patients.

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): NCT02505802


Contacts
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Contact: TAO WU, MD 86 571 86006054 wutao1880@163.com
Contact: JIANHUA LI, MD 86 571 86006054 zjdxsyfkfk@126.com

Locations
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China, Zhejiang
Sir Run Run Shaw Hospital, Medical College of Zhejiang University Recruiting
Hang Zhou, Zhejiang, China, 310016
Contact: TAO WU, MD       wutao1880@163.com   
Contact: JIANHUA LI, MD       zjdxsyfkfk@126.com   
Sponsors and Collaborators
Sir Run Run Shaw Hospital
Investigators
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Study Director: TAO WU, MD Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University
Publications of Results:

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Responsible Party: TAO WU, MD, Sir Run Run Shaw Hospital
ClinicalTrials.gov Identifier: NCT02505802    
Other Study ID Numbers: 2013KYB163
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: July 22, 2015
Last Verified: July 2015
Keywords provided by TAO WU, Sir Run Run Shaw Hospital:
Stroke
Botulinum Toxins
Muscle Spasticity
Gait
Additional relevant MeSH terms:
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Muscle Spasticity
Stroke
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
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs