Skip to main content
OpenTrials
Completed

NCT Number: NCT05889026

The Effect of Extracorporeal Shock Wave Therapy After Botulinum Toxin Type A Injection for Post-stroke Spasticity

There are few studies on whether botulinum toxin treatment and extracorporeal shock wave therapy are more effective than botulinum toxin alone treatment for post-stroke spasticity.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Korea university guro hospital

Seoul, South Korea

About this study

If the study results can be drawn that the group receiving extracorporeal shock wave therapy along with botulinum toxin treatment can increase the effect of botulinum toxin treatment and lengthen the treatment period compared to the group with botulinum toxin treatment only, it can be widely used as an auxiliary treatment for botulinum toxin treatment. This study was carried out with the expectation that it would be possible to provide a basis for this.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • at least 6 weeks after stroke diagnosis
  • upper-extremity (elbow, wrist and finger) spasticity Modified Ashworth Scale (MAS) score > 2
  • ability to stand and walk safely without help or assistance

Exclusion criteria

  • improper indication for botulinum toxin A (BTxA) injection, for example, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, and motor neuropathy
  • previous contracture and/or deformity of the upper extremities
  • concurrent peripheral neuropathy and/or myopathy
  • difficulty in participating in the study due to cognitive impairment.

Treatment and study plan

Extracorporeal Shock Wave Therapy

Device

Stimulation was given to the brachial muscle, 1000 times, 4Hz, and energy flux density was 0.030mJ/mm2.

Botulinum toxin treatment

Procedure

The toxin dose was established for each patient: it ranged between 80 unit and 300 unit.

Primary outcomes

  1. Modified ashworth scale of upper extremities spasticity

    Time frame: Pre-treatment (baseline)

    minimum grade 0, maximum grade 4 / higher grade means severe spasticity

  2. Modified ashworth scale of upper extremities spasticity

    Time frame: Three weeks after treatment

    minimum grade 0, maximum grade 4 / higher grade means severe spasticity

  3. Modified ashworth scale of upper extremities spasticity

    Time frame: Three months after treatment

    minimum grade 0, maximum grade 4 / higher grade means severe spasticity

Secondary outcomes

  1. Modified tardieu scale of upper extremities spasticity

    Time frame: Pre-treatment (baseline)

    Unit : degree / higher degree means little limitation of range of motion

  2. Modified tardieu scale of upper extremities spasticity

    Time frame: Three weeks after treatment

    Unit : degree / higher degree means little limitation of range of motion

  3. Modified tardieu scale of upper extremities spasticity

    Time frame: Three months after treatment

    Unit : degree / higher degree means little limitation of range of motion

  4. Fugl-Meyer assessment of upper extremity Fugl-Meyer assessment of upper extremity Fugl-Meyer assessment of upper extremity Fugl-Meyer assessment of upper extremity

    Time frame: Pre-treatment (baseline)

    Minimum score 0, maximum score 66 / higher score means better function of upper extremity

  5. Fugl-Meyer assessment of upper extremity

    Time frame: Three months after treatment

    Minimum score 0, maximum score 66 / higher score means better function of upper extremity

  6. Action research arm test

    Time frame: Pre-treatment (baseline)

    Minimum score 0, maximum score 57 / higher score means better function of upper extremity

  7. Action research arm test

    Time frame: Three weeks after treatment

    Minimum score 0, maximum score 57 / higher score means better function of upper extremity

  8. Action research arm test

    Time frame: Three months after treatment

    Minimum score 0, maximum score 57 / higher score means better function of upper extremity

  9. Modified barthel index

    Time frame: Pre-treatment (baseline)

    Minimum score 0, maximum score 100 (if w/c ambulation, 90) / higher score means better capacity for activities of daily living

  10. Modified barthel index

    Time frame: Three weeks after treatment

    Minimum score 0, maximum score 100 (if w/c ambulation, 90) / higher score means better capacity for activities of daily living

  11. Modified barthel index

    Time frame: Three months after treatment

    Minimum score 0, maximum score 100 (if w/c ambulation, 90) / higher score means better capacity for activities of daily living

Sponsors and collaborators

Lead sponsor

Korea University Guro Hospital

Other

Collaborators

  • Daewoong Pharmaceutical Co. LTD.

Registry information

Official study title

The Effect of Extracorporeal Shock Wave Therapy After Botulinum Toxin Type A Injection for Post-stroke Spasticity: Preliminary Study, Randomized Controlled Trials

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 5, 2023
Registry last updated
Jun 5, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.