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StrokeNCT05878223

Comparing ESWT Doses for Post-Stroke Ankle Spasticity Treatment

A study testing Extracorporeal shock waves in people with Stroke, run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Stroke
What is being tested?
Extracorporeal shock waves
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteTaiwan
Study dates
1 Jan 2022to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Yen-Hua Chen, Master contact

+8863-5326151 ext. 523504

G54089@hch.gov.tw

Shu-mei Yang, MD contact

0972653754

b99401109@gmail.com

Taiwan1 site, 1 recruiting

  • National Taiwan University Hospital Hsin-Chu Branch

    Hsinchu

    Shu-mei Yang, MD, 0972653754, b99401109@gmail.com

    Recruiting

Other trials in Taiwan

About this study

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

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.

Read the 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.

Conditions
Stroke
Being tested
Extracorporeal shock waves
Keywords
stroke, spasticity, shock wave, ankle
Medical subject headings
Stroke, Muscle Spasticity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Extracorporeal shock wavesDevice

    Both group received extracorporeal shock waves therapy

Study groups in NCT05878223
Study groupRoleWhat they receive
ESWT to gastrocnemius and soleusExperimentalESWT to gastrocnemius and soleus muscles (2000 shots for each muscle, a total of 4000 shots per session)
Receives: Device: Extracorporeal shock waves
ESWT to gastrocnemiusActive comparatorESWT to gastrocnemius muscle (2000 shots per session)
Receives: Device: Extracorporeal shock waves

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Modified Ashworth Scale (MAS)

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

    Measured: 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)

  1. Change in Level of mobility and balance

    Timed Up \& Go Test

    Measured: 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

  2. Ultrasound evaluations

    Strain elastography of gastrocnemius muscle

    Measured: 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

  3. Barthel index

    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.

    Measured: 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

  4. Change in modified Tardieu scale (mTS)

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

    Measured: 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

  5. Change in Passive ROM of the ankle in dorsiflexion

    Passive ankle Range of Motion (PROM)

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2023
  2. Study start1 Jan 2022
  3. Primary completion30 Jul 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05878223
Sponsor's protocol ID
111-044-F
Status last verified
Jul 2024
First submitted
3 Jan 2023
Last updated
17 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21707868

  • 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.

    PubMed 19601786

  • 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.

    PubMed 28971038

  • 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.

    PubMed 34566855

  • 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.

    PubMed 27149465

  • 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.

    PubMed 39354619

Questions about this trial

What is this clinical trial studying?

A study testing Extracorporeal shock waves in people with Stroke, run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yen-Hua Chen, Master (+8863-5326151 ext. 523504, G54089@hch.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05878223, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.

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Clinical Trial NCT05878223 | AzTrials