Comparing ESWT Doses for Post-Stroke Ankle Spasticity Treatment

Not Applicable

Recruiting

• Conditions: Stroke
• Interventions: Device: Extracorporeal shock waves

• Registration Number: NCT05878223
• Lead Sponsor: National Taiwan University Hospital Hsin-Chu Branch

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.

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2023-01-03
• Study First Submitted QC: 2023-05-17
• Study First Posted: 2023-05-26
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-17
• Primary Completion: 2024-07-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESWT to gastrocnemius	Extracorporeal shock waves	ESWT to gastrocnemius muscle (2000 shots per session)
ESWT to gastrocnemius and soleus	Extracorporeal shock waves	ESWT to gastrocnemius and soleus muscles (2000 shots for each muscle, a total of 4000 shots per session)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

National Taiwan University Hospital Hsin-Chu Branch; 🇨🇳 Hsinchu, Taiwan