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NCT Number: NCT05878223

Comparing ESWT Doses for Post-Stroke Ankle Spasticity Treatment

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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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, Taiwan

Location status: Recruiting

Location contact

Shu-mei Yang, MD

CONTACT

[email protected]

0972653754

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extracorporeal shock waves

Device

Both group received extracorporeal shock waves therapy

Primary outcomes

  1. 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

  1. Change in Level of mobility and balance

    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

    Timed Up & Go Test

  2. Ultrasound evaluations

    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

    Strain elastography of gastrocnemius muscle

  3. Barthel index

    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

    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.

  4. Change in modified Tardieu scale (mTS)

    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 Tardieu scale (mTS). Score from 0 to 5, higher scores mean a worse outcome

  5. Change in Passive ROM of the ankle in dorsiflexion

    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

    Passive ankle Range of Motion (PROM)

Study contacts

Contact information is provided by the study sponsor or research team.

Shu-mei Yang, MD

CONTACT

[email protected]

0972653754

Yen-Hua Chen, Master

CONTACT

[email protected]

+8863-5326151 ext. 523504

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital Hsin-Chu Branch

Other

Registry information

Official study title

The Dose Effectiveness of Extracorporeal Shockwave on Plantar Flexor Spasticity of Ankle in Stroke Patients: a Randomised Controlled Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 26, 2023
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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