The Dose Effectiveness of Extracorporeal Shockwave on Plantar Flexor Spasticity of Ankle in Stroke Patients: a Randomised Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- National Taiwan University Hospital Hsin-Chu Branch
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change in Modified Ashworth Scale (MAS)
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject with Cerebral stroke and age more 20
- •The degree of spasticity of plantar flexor is more than 1.( grading with the modified Ashworth scale)
- •Stable vital sign
Exclusion Criteria
- •Recurrent cerebral stroke, traumatic brain injury, brain tumor or other brain related disease.
- •Other central nervous system diseases (SCI, Parkinson's disease), or other musculoskeletal disorders which affect the result of evaluating muscle spasticity.
- •Malignant tumor, coagulation disorder, infection or use of pace which were not suitable for Extracorporeal Shock Wave.
- •Received Extracorporeal Shock Wave or Botulinum injection for plantar flexor spasticity in recent 3 months.
- •Subjects who was unable to complete Extracorporeal Shock Wave or evaluation due to impaired cognition or aphasia.
Outcomes
Primary Outcomes
Change in Modified Ashworth Scale (MAS)
Time Frame: 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 Outcomes
- 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)
- 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)
- 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)
- 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)
- 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)