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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05889026
Other study ID # ESWT RCT
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 6, 2020
Est. completion date September 8, 2021

Study information

Verified date May 2023
Source Korea University Guro Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date September 8, 2021
Est. primary completion date September 8, 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years to 80 Years
Eligibility Inclusion Criteria: 1. at least 6 weeks after stroke diagnosis 2. upper-extremity (elbow, wrist and finger) spasticity Modified Ashworth Scale (MAS) score > 2 3. ability to stand and walk safely without help or assistance Exclusion Criteria: 1. improper indication for botulinum toxin A (BTxA) injection, for example, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, and motor neuropathy 2. previous contracture and/or deformity of the upper extremities 3. concurrent peripheral neuropathy and/or myopathy 4. difficulty in participating in the study due to cognitive impairment.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Extracorporeal shock wave therapy
Stimulation was given to the brachial muscle, 1000 times, 4Hz, and energy flux density was 0.030mJ/mm2.
Procedure:
Botulinum toxin treatment
The toxin dose was established for each patient: it ranged between 80 unit and 300 unit.

Locations

Country Name City State
Korea, Republic of Korea university guro hospital Seoul

Sponsors (2)

Lead Sponsor Collaborator
Korea University Guro Hospital Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Modified ashworth scale of upper extremities spasticity minimum grade 0, maximum grade 4 / higher grade means severe spasticity Pre-treatment (baseline)
Primary Modified ashworth scale of upper extremities spasticity minimum grade 0, maximum grade 4 / higher grade means severe spasticity Three weeks after treatment
Primary Modified ashworth scale of upper extremities spasticity minimum grade 0, maximum grade 4 / higher grade means severe spasticity Three months after treatment
Secondary Modified tardieu scale of upper extremities spasticity Unit : degree / higher degree means little limitation of range of motion Pre-treatment (baseline)
Secondary Modified tardieu scale of upper extremities spasticity Unit : degree / higher degree means little limitation of range of motion Three weeks after treatment
Secondary Modified tardieu scale of upper extremities spasticity Unit : degree / higher degree means little limitation of range of motion Three months after treatment
Secondary Fugl-Meyer assessment of upper extremity Fugl-Meyer assessment of upper extremity Fugl-Meyer assessment of upper extremity Fugl-Meyer assessment of upper extremity Minimum score 0, maximum score 66 / higher score means better function of upper extremity Pre-treatment (baseline)
Secondary Fugl-Meyer assessment of upper extremity Minimum score 0, maximum score 66 / higher score means better function of upper extremity Three months after treatment
Secondary Action research arm test Minimum score 0, maximum score 57 / higher score means better function of upper extremity Pre-treatment (baseline)
Secondary Action research arm test Minimum score 0, maximum score 57 / higher score means better function of upper extremity Three weeks after treatment
Secondary Action research arm test Minimum score 0, maximum score 57 / higher score means better function of upper extremity Three months after treatment
Secondary Modified barthel index Minimum score 0, maximum score 100 (if w/c ambulation, 90) / higher score means better capacity for activities of daily living Pre-treatment (baseline)
Secondary Modified barthel index Minimum score 0, maximum score 100 (if w/c ambulation, 90) / higher score means better capacity for activities of daily living Three weeks after treatment
Secondary Modified barthel index Minimum score 0, maximum score 100 (if w/c ambulation, 90) / higher score means better capacity for activities of daily living Three months after treatment
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