Clinical trial NCT05889026: The Effect of Extracorporeal Shock Wave Therapy After Botulinum Toxin Type A Injection for Post-stroke Spasticity
Official title: The Effect of Extracorporeal Shock Wave Therapy After Botulinum Toxin Type A Injection for Post-stroke Spasticity: Preliminary Study, Randomized Controlled Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Hemiplegia, Spastic
Muscle Spasticity
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
Collaborators: name: Daewoong Pharmaceutical Co. LTD.
First posted: 2023-06-05
Enrollment: 16
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Modified ashworth scale of upper extremities spasticity
timeFrame: Pre-treatment (baseline)
measure: Modified ashworth scale of upper extremities spasticity
timeFrame: Three weeks after treatment
measure: Modified ashworth scale of upper extremities spasticity
timeFrame: Three months after treatment
Secondary outcomes:
measure: Modified tardieu scale of upper extremities spasticity
timeFrame: Pre-treatment (baseline)
measure: Modified tardieu scale of upper extremities spasticity
timeFrame: Three weeks after treatment
measure: Modified tardieu scale of upper extremities spasticity
timeFrame: Three months after treatment
measure: Fugl-Meyer assessment of upper extremity Fugl-Meyer assessment of upper extremity Fugl-Meyer assessment of upper extremity Fugl-Meyer assessment of upper extremity
timeFrame: Pre-treatment (baseline)
measure: Fugl-Meyer assessment of upper extremity
timeFrame: Three months after treatment
measure: Action research arm test
timeFrame: Pre-treatment (baseline)
measure: Action research arm test
timeFrame: Three weeks after treatment
measure: Action research arm test
timeFrame: Three months after treatment
measure: Modified barthel index
timeFrame: Pre-treatment (baseline)
measure: Modified barthel index
timeFrame: Three weeks after treatment
measure: Modified barthel index
timeFrame: Three months after treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea university guro hospital
Study officials:
References: