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

July 20, 2015 updated by: TAO WU, Sir Run Run Shaw Hospital

Phase III Study of Botulinum Toxin A Injection for Lower Limbs Spasticity in Subacute Stroke Adults

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hang Zhou, Zhejiang, China, 310016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • Botulinum toxin A
No Intervention: Control group
No special treatment was performed in the control group. Both groups received comprehensive rehabilitation for 8 weeks.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lower limbs Fugl-Meyer (FM) score
Time Frame: The outcome will be undertaken at weeks 0 (baseline), 8, 12 and 24 weeks later
The outcome will be undertaken at weeks 0 (baseline), 8, 12 and 24 weeks later
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.
The outcome will be undertaken at weeks 0 (baseline), 8, 12 and 24 weeks later
6-min walking distance
Time Frame: The outcome will be were assessed 8, 12, 24 weeks after injection.
The outcome will be were assessed 8, 12, 24 weeks after injection.
Gait analysis (step length，cadence，speed).
Time Frame: The outcome will be undertaken at weeks 0 (baseline), 8, 12 and 24 weeks later
The outcome will be undertaken at weeks 0 (baseline), 8, 12 and 24 weeks later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sir Run Run Shaw Hospital

Investigators

  • Study Director: TAO WU, MD, Sir Run Run Shaw Hospital, College of medicine, Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

July 17, 2015

First Submitted That Met QC Criteria

July 20, 2015

First Posted (Estimate)

July 22, 2015

Study Record Updates

Last Update Posted (Estimate)

July 22, 2015

Last Update Submitted That Met QC Criteria

July 20, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013KYB163

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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