Comparing ESWT Doses for Post-Stroke Ankle Spasticity Treatment

National Taiwan University Hospital Hsin-Chu Branch

Status: Enrolling

Conditions: Stroke

Treatments: Device: Extracorporeal shock waves

Study type: Interventional

Funder types: Other

Identifiers

NCT05878223

111-044-F

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

ESWT to gastrocnemius and soleus

Experimental group

Description:

ESWT to gastrocnemius and soleus muscles (2000 shots for each muscle, a total of 4000 shots per session)

Treatment:

Device: Extracorporeal shock waves

ESWT to gastrocnemius

Active Comparator group

Description:

ESWT to gastrocnemius muscle (2000 shots per session)

Treatment:

Device: Extracorporeal shock waves