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Completed

NCT Number: NCT01817816

Early Injection of Botulinum Toxin on Motor Function and Gait Pattern in Stroke Patients

Spasticity, muscle weakness, abnormal gait pattern are co-morbidities commonly seen in stroke patients. They cause disabled condition of patients in activities of daily life and functional performance, and also accidental falls and subsequent fractures.

This study is to evaluate and compare the effects of different phase injection of Botulinum Toxin Type-A at affected limbs on muscle rheological changes, muscle activity, muscle tone, functional performance, gait pattern and energy consumption in stroke patients.

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Key information

Conditions

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

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changhua Christian Hospital

Dawan, Changhua, 500, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • first-ever stroke, with spasticity within 3-months (MAS=2~3)
  • independent walking 10 meters (with assistive devices)

Exclusion criteria

  • recurrent stroke, cognition impaired
  • lower limb fracture
  • received anti-spasticity injection in the past

Treatment and study plan

Botox_A

Procedure

Botox_B

Procedure

Primary outcomes

  1. Change in the muscle tone in upper and lower extremity

    Time frame: 4 weeks after injection

    use modified Ashworth Scale to access elbow, wrist, ankle joint muscle tone 0: normal

    • slight hypertonus, at the end-range 1+: mild hypertonus, catch when limb is moved (<1/2)
    • moderate hypertonus,, limbs moves easily (>1/2)
    • passive movement difficult
    • rigid

Secondary outcomes

  1. Change in the gait pattern as walking

    Time frame: 4 weeks after intervention

Sponsors and collaborators

Lead sponsor

Changhua Christian Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Mar 25, 2013
Registry last updated
Nov 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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