Comparing ESWT Doses for Post-Stroke Ankle Spasticity Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

participants

Study Groups

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ESWT to gastrocnemius and soleus

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

Group Type EXPERIMENTAL

Extracorporeal shock waves

Intervention Type DEVICE

Both group received extracorporeal shock waves therapy

ESWT to gastrocnemius

ESWT to gastrocnemius muscle (2000 shots per session)

Group Type ACTIVE_COMPARATOR

Extracorporeal shock waves

Intervention Type DEVICE

Both group received extracorporeal shock waves therapy

Interventions

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Extracorporeal shock waves

Both group received extracorporeal shock waves therapy

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No