Stroke Clinical Trial
Official title:
The Effect of Extracorporeal Shock Wave Therapy After Botulinum Toxin Type A Injection for Post-stroke Spasticity: Preliminary Study, Randomized Controlled Trials
Verified date | May 2023 |
Source | Korea University Guro Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Korea university guro hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Korea University Guro Hospital | Daewoong Pharmaceutical Co. LTD. |
Korea, Republic of,
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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