Hemiplegia, Spastic, Muscle Spasticity, Stroke
Conditions
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.
Interventions
DEVICEExtracorporeal shock wave therapy
Stimulation was given to the brachial muscle, 1000 times, 4Hz, and energy flux density was 0.030mJ/mm2.
PROCEDUREBotulinum toxin treatment
The toxin dose was established for each patient: it ranged between 80 unit and 300 unit.
Sponsors
Daewoong Pharmaceutical Co. LTD.
Korea University Guro Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified ashworth scale of upper extremities spasticity | Pre-treatment (baseline) | minimum grade 0, maximum grade 4 / higher grade means severe spasticity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified tardieu scale of upper extremities spasticity | Pre-treatment (baseline) | Unit : degree / higher degree means little limitation of range of motion |
| Fugl-Meyer assessment of upper extremity Fugl-Meyer assessment of upper extremity Fugl-Meyer assessment of upper extremity Fugl-Meyer assessment of upper extremity | Pre-treatment (baseline) | Minimum score 0, maximum score 66 / higher score means better function of upper extremity |
| Fugl-Meyer assessment of upper extremity | Three months after treatment | Minimum score 0, maximum score 66 / higher score means better function of upper extremity |
| Action research arm test | Pre-treatment (baseline) | Minimum score 0, maximum score 57 / higher score means better function of upper extremity |
| Modified barthel index | Pre-treatment (baseline) | Minimum score 0, maximum score 100 (if w/c ambulation, 90) / higher score means better capacity for activities of daily living |
Countries
South Korea
Outcome results
None listed