Post-Stroke Upper Limb Spasticity
Conditions
Keywords
Extracorporeal Shock Wave, Spasticity in stokes, Botulinum toxin
Brief summary
Botulinum toxin type A (BoNT-A) is widely used in the clinics to reduce spasticity and improve upper limb function for post-stroke patients. However, there were no studies to compare the effect of rESWT and BoNT-A injection for treatment on spasticity.
Detailed description
Botulinum toxin type A (BoNT-A) is widely used in the clinics to reduce spasticity and improve upper limb function for post-stroke patients. However, the treatments of BoNT-A injection are associated with high cost and invasive treatment. Recent studies have showed that radial extracorporeal shock wave (rESWT) is a novel, effective and safety treatment method for the spasticity. However, there were no studies to compare the effect of rESWT and BoNT-A injection for treatment on spasticity.
Interventions
DEVICEShock Wave
42 chronic stroke patients with upper limb spasticity were randomly assigned to receive either 1 session of ESWT per week for 3 consecutive weeks or BoNT-A injection. The biceps, flexor carpi radialis, and flexor carpi ulnaris muscles were treated. Assessments were performed at baseline and at 1, 4, and 8 weeks after the intervention. The primary outcome measure was the change in the Modified Ashworth Scale (MAS) score for the elbow from the baseline to after 4 weeks of treatment.
DRUGBotulinum toxin A
42 chronic stroke patients with upper limb spasticity were randomly assigned to receive either 1 session of ESWT per week for 3 consecutive weeks or BoNT-A injection. The biceps, flexor carpi radialis, and flexor carpi ulnaris muscles were treated. Assessments were performed at baseline and at 1, 4, and 8 weeks after the intervention. The primary outcome measure was the change in the Modified Ashworth Scale (MAS) score for the elbow from the baseline to after 4 weeks of treatment.
Sponsors
Mackay Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
group A : shock wave, group B: Botulinum Toxin Injection
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Aged between 18-80 year-old 2. The onset of stroke must be at least 6 months previously 3. Spasticity measured as Modified Asthow Scale more(MAS) than 1+ 4. Signed informed consent form
Exclusion criteria
1. Patients with marked contractures in the elbow and wrist (MAS\>4) 2. Resistant hypertension, coagulation disorders, malignant tumors, pregnancy, pacemakers, cognitive disorders 3. Prior or planned treatment with phenol or alcohol nerve blocks, intrathecal baclofen, or BoNT-A injection within the six months preceding the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of spasticity of elbow | Between baseline and 4 weeks post-treatment | Modified Ashworth Scale (MAS) for spasticity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change of Tardieu scale scores for the elbow and wrist | Between baseline and 1, 4,8 weeks post-treatment | Tardieu scale scores for spasticity |
| The change of upper limb function | Between baseline and 1,4,8 weeks post-treatment | The Fugl-Meyer Assessment (FMA) for upper limb function |
Countries
Taiwan
Outcome results
None listed