Comparing ESWT Doses for Post-Stroke Ankle Spasticity Treatment

NCT05878223 | Recruiting

• 1 other identifier: 111-044-F
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke; spasticity; shock wave; ankle

Outcome Measures

Primary Outcomes (1)

• Change in Modified Ashworth Scale (MAS)

  Modified Ashworth Scale (MAS). Score from 0 to 4, higher scores mean a worse outcome

  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

Secondary Outcomes (5)

• 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

Study Arms (2)

ESWT to gastrocnemius and soleus

EXPERIMENTAL

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

Device: Extracorporeal shock waves

ESWT to gastrocnemius

ACTIVE COMPARATOR

ESWT to gastrocnemius muscle (2000 shots per session)

Device: Extracorporeal shock waves

Interventions

Extracorporeal shock waves DEVICE

Both group received extracorporeal shock waves therapy

ESWT to gastrocnemius; ESWT to gastrocnemius and soleus

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital Hsin-Chu Branch: lead

Study Sites (1)

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, Taiwan

RECRUITING

Related Publications (6)

• Ward AB. A literature review of the pathophysiology and onset of post-stroke spasticity. Eur J Neurol. 2012 Jan;19(1):21-7. doi: 10.1111/j.1468-1331.2011.03448.x. Epub 2011 Jun 27.

  PMID: 21707868 BACKGROUND

• Mariotto S, de Prati AC, Cavalieri E, Amelio E, Marlinghaus E, Suzuki H. Extracorporeal shock wave therapy in inflammatory diseases: molecular mechanism that triggers anti-inflammatory action. Curr Med Chem. 2009;16(19):2366-72. doi: 10.2174/092986709788682119.

  PMID: 19601786 BACKGROUND

• Yoon SH, Shin MK, Choi EJ, Kang HJ. Effective Site for the Application of Extracorporeal Shock-Wave Therapy on Spasticity in Chronic Stroke: Muscle Belly or Myotendinous Junction. Ann Rehabil Med. 2017 Aug;41(4):547-555. doi: 10.5535/arm.2017.41.4.547. Epub 2017 Aug 31.

  PMID: 28971038 BACKGROUND

• Fan T, Zhou X, He P, Zhan X, Zheng P, Chen R, Li R, Li R, Wei M, Zhang X, Huang G. Effects of Radial Extracorporeal Shock Wave Therapy on Flexor Spasticity of the Upper Limb in Post-stroke Patients: Study Protocol for a Randomized Controlled Trial. Front Neurol. 2021 Sep 9;12:712512. doi: 10.3389/fneur.2021.712512. eCollection 2021.

  PMID: 34566855 BACKGROUND

• Li TY, Chang CY, Chou YC, Chen LC, Chu HY, Chiang SL, Chang ST, Wu YT. Effect of Radial Shock Wave Therapy on Spasticity of the Upper Limb in Patients With Chronic Stroke: A Prospective, Randomized, Single Blind, Controlled Trial. Medicine (Baltimore). 2016 May;95(18):e3544. doi: 10.1097/MD.0000000000003544.

  PMID: 27149465 RESULT

• Yang SM, Chen YH, Lu YL, Wu CH, Chen WS, Lin MT. The dose effectiveness of extracorporeal shockwave on plantar flexor spasticity of ankle in stroke patients: a randomized controlled trial. J Neuroeng Rehabil. 2024 Oct 1;21(1):176. doi: 10.1186/s12984-024-01473-z.

  PMID: 39354619 DERIVED

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Condition Hierarchy (Ancestors)

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

Study Officials

• Meng Ting Lin, MD

  The Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yen-Hua Chen, Master

CONTACT

+8863-5326151; G54089@hch.gov.tw

Shu-mei Yang, MD

CONTACT

0972653754; b99401109@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: participants
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: May 26, 2023
• Study Start: January 1, 2022
• Primary Completion: July 30, 2024
• Study Completion: December 31, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)