Stroke
Conditions
Keywords
stroke, spasticity, shock wave, ankle
Brief summary
Post-stroke spasticity is a common complication affecting the neurological recovery, self-care daily activities and patients' quality of life. Extracorporeal shock waves (ESWT) have been proven therapeutic effects on decreasing spasticity and regaining function. Stroke patients often suffer ankle plantar flexor spasticity with poor ankle movement control, leading to abnormal gait patterns and risk of falling; local pain appears as well in the ankle. Research showed application of ESWT to lower extremity spasticity reduced ankle plantar flexor spasticity, ankle pain and increased the range of ankle motion. However, the current study did not investigate the effect of ESWT on different muscles in patients with post-stroke ankle spasticity. Therefore, this study will compare the effect of focused ESWT on combination of the gastrocnemius and soleus muscles to gastrocnemius muscle alone in the post-stroke ankle plantar flexor spasticity.
Detailed description
This study design was a single-blind randomized controlled trial and planned to recruit 40 chronic stroke patients with ankle plantar flexor spasticity. The patients were randomly assigned to two groups. The experimental group received focused ESWT to gastrocnemius and soleus muscles (a total of 4000 shots per session), while the control group received focused ESWT to gastrocnemius muscle (2000 shots per session). Patients in both groups underwent a total of 4 sessions ESWT, twice a week for two consecutive weeks. The primary outcome was modified Ashworth scale; the secondary outcomes were modified Tardieu scale, passive range of ankle motions and timed up and go test, and strain elastography. The outcomes were assessed before ESWT and after ESWT at 1, 4, 12, and 24 week.
Interventions
Both group received extracorporeal shock waves therapy
Sponsors
National Taiwan University Hospital Hsin-Chu Branch
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
participants
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject with Cerebral stroke and age more 20 2. The degree of spasticity of plantar flexor is more than 1.( grading with the modified Ashworth scale) 3. Stable vital sign
Exclusion criteria
1. Recurrent cerebral stroke, traumatic brain injury, brain tumor or other brain related disease. 2. Other central nervous system diseases (SCI, Parkinson's disease), or other musculoskeletal disorders which affect the result of evaluating muscle spasticity. 3. Malignant tumor, coagulation disorder, infection or use of pace which were not suitable for Extracorporeal Shock Wave. 4. Received Extracorporeal Shock Wave or Botulinum injection for plantar flexor spasticity in recent 3 months. 5. Subjects who was unable to complete Extracorporeal Shock Wave or evaluation due to impaired cognition or aphasia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Modified Ashworth Scale (MAS) | T0 Enrollment, T1 after 1 week from T0, T2 after 4 weeks from T0, T3 after 12 weeks from T0, T4 after 24 weeks from T0 | Modified Ashworth Scale (MAS). Score from 0 to 4, higher scores mean a worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Level of mobility and balance | T0 Enrollment, T1 after 1 week from T0, T2 after 4 weeks from T0, T3 after 12 weeks from T0, T4 after 24 weeks from T0 | Timed Up & Go Test |
| Ultrasound evaluations | T0 Enrollment, T1 after 1 week from T0, T2 after 4 weeks from T0, T3 after 12 weeks from T0, T4 after 24 weeks from T0 | Strain elastography of gastrocnemius muscle |
| Barthel index | T0 Enrollment, T1 after 1 week from T0, T2 after 4 weeks from T0, T3 after 12 weeks from T0, T4 after 24 weeks from T0 | measures a person's daily living abilities, focusing on ten areas of self-care and mobility. Scores range from 0 to 100, with higher scores denoting greater independence. |
| Change in modified Tardieu scale (mTS) | T0 Enrollment, T1 after 1 week from T0, T2 after 4 weeks from T0, T3 after 12 weeks from T0, T4 after 24 weeks from T0 | Modified Tardieu scale (mTS). Score from 0 to 5, higher scores mean a worse outcome |
| Change in Passive ROM of the ankle in dorsiflexion | T0 Enrollment, T1 after 1 week from T0, T2 after 4 weeks from T0, T3 after 12 weeks from T0, T4 after 24 weeks from T0 | Passive ankle Range of Motion (PROM) |
Countries
Taiwan
Contacts
Primary ContactYen-Hua Chen, Master
Backup ContactShu-mei Yang, MD
Outcome results
None listed