AzTrials
AzTrials

StrokeNCT06225024

Efficacy of Extracorporeal Shock Wave Therapy on Spasticity

A study testing ESWT and BoNT A in people with Stroke and Spasticity, Muscle, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Introduction: We aimed to compare the efficacy of Botulinum Toxin Type A(BoNT-A) injection and BoNT-A injection in combination with ESWT for post-stroke lower extremity ankle plantar flexor spasticity. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Spasticity, Muscle
What is being tested?
ESWT and BoNT A
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Mar 2022to 15 Jun 2023
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Being diagnosed with stroke according to the definition of the World Health Organization in 1989
  • Having a stroke confirmed by computed tomography (CT) and magnetic resonance imaging (MRI)
  • Being aged over 18 years
  • Having a MAS score of 1 and above for gastrocnemius, the plantar flexor muscle of the ankle
  • Having a stable general condition after a stroke
  • Giving consent to participate in the study.

Who cannot join

  • Having a fixed contracture in the ankle
  • Having no spasticity in the soleus, the plantar flexor muscle of the ankle
  • Previous antispastic surgery performed on the area
  • Change in antispastic drug use in the last six months, if any
  • Injection of BoNT-A, alcohol, phenol, or any other substance into the area in the last six months
  • Active infection or cancer at the application site
Show all 13Show fewer
  • Having a cardiac pacemaker
  • Having bleeding diathesis
  • Having vascular complaints such as deep vein thrombosis, venous stasis, phlebitis, arterial disease
  • Being pregnant
  • Having neuromuscular junction disease or motor neuron disease
  • Having a known allergy to BoNT-A
  • 12. Active use of aminoglycosides or other antibiotic groups.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Health Sciences University, Kayseri Medicine Faculty

    Kayseri, Kocasinan, 38080

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Efficacy of Extracorporeal Shock Wave Therapy (ESWT) Following Botulinum Toxin Type A Injection on Post-Stroke Ankle Plantar Flexor Spasticity

Introduction: We aimed to compare the efficacy of Botulinum Toxin Type A(BoNT-A) injection and BoNT-A injection in combination with ESWT for post-stroke lower extremity ankle plantar flexor spasticity.

Materials and Method: Patients with post-stroke ankle plantar flexor spasticity of 1 or more on the modified Ashworth Scale(MAS) were randomized into two groups.

Group 1(n:20): BoNT-A was injected into the gastrocnemius muscle and conventional physical therapy exercises were performed.

Group 2(n:20): ESWT was applied to the gastrocnemius muscle in addition to the treatments in group 1.

Read the detailed description

Group 1 (n:20): BoNT-A was injected into the affected gastrocnemius muscle under ultrasonography guidance at doses recommended by standard guidelines and appropriate for the patient (50 IU to the medial head, 25 IU to the lateral head). In addition, conventional physical therapy exercises (stretching exercises, range of motion (ROM) exercises, neurophysiologic exercises, and gait exercises) were applied to the patients five days a week for four weeks.

Group 2 (n:20): In addition to the treatments (BoNT-A injection and exercise) in Group 1, one week after the injection, a total of 4 sessions (2 days a week) of ESWT (1000 impulses with an energy density of 0.1 mj/mm2, pressure of 2 bar, and frequency of 4 Hz) were applied to the medial and lateral heads of the gastrocnemius muscle.

The patients in both groups underwent the following evaluations before treatment, at one month and three months after treatment by a treatment-blinded Physical Medicine and Rehabilitation (PMR) physician.

Patients' age, sex, occupation, hemiplegic sides, and etiology of hemiplegia were recorded. Physical examination was performed, and examination findings were recorded. The presence of post-treatment pain, redness, tenderness, or other adverse findings were questioned.

MAS, Brunnstrom Motor Recovery Stage(BMRS), ankle range of motion(ROM) measurement, clonus score(CS), Barthel Index(BI), Heckmatt measurements with ultrasonography, and visual analog scale(VAS) evaluations were performed on the patients.

Being tested
ESWT, BoNT A
Keywords
Botulinum Toxin A, ESWT, Stroke, Spasticity, Modified Ashworth Scale, Heckmatt Scale
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.

  • ESWTDevice

    Also called device therapy

    Extracorporeal shock wave therapy (ESWT) is a treatment method based on high-intensity sound waves focusing on the desired body area to provide treatment. ESWT is a safe, non-invasive, alternative treatment for spasticity in patients with stroke, cerebral palsy, and multiple sclerosis and does not cause muscle weakness or adverse effects

  • BoNT ADrug

    Also called drug therapy

    BoNT-A is widely recognized as the benchmark for enhancing the effectiveness of spasticity management

Study groups in NCT06225024
Study groupRoleWhat they receive
BoNT-AActive comparatorBoNT-A was injected into the affected gastrocnemius muscle under ultrasonography guidance at doses recommended by standard guidelines and appropriate for the patient (50 IU to the medial head, 25 IU to the lateral head). In addition, conventional physical therapy exercises (stretching exercises, range of motion (ROM) exercises, neurophysiologic exercises, and gait exercises) were applied to the patients five days a week for four weeks.
Receives: Drug: BoNT A
BoNT-A and ESWTExperimentalIn addition to the treatments (BoNT-A injection and exercise) in Group 1, one week after the injection, a total of 4 sessions (2 days a week) of ESWT (1000 impulses with an energy density of 0.1 mj/mm2, pressure of 2 bar, and frequency of 4 Hz) were applied to the medial and lateral heads of the gastrocnemius muscle.
Receives: Device: ESWT; Drug: BoNT A

What is being measured

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

  1. Modified Ashworth Scale (MAS)

    This scale is used to evaluate the severity of spasticity. MAS is based on a subjective evaluation of the resistance felt during the examination.

    0: No tone increase

    1. Slight increase in tone characterized by a catch and release or minimal resistance at the end of the range of motion 1+: Slight increase in muscle tone with minimal resistance throughout less than half of the range of motion
    2. Increased muscle tone throughout the entire range of motion, but joints can be easily moved
    3. Considerable increase in tone; passive movement is difficult
    4. Affected parts are rigid in flexion and extension.

    Measured: at baseline, at one month and three months after treatment

Secondary outcomes (1)

  1. Brunnstrom Motor Recovery Stage (BMRS)

    It is a motor function assessment scale to evaluate the motor development of hemiplegic patients. According to Brunnstrom, there are six stages in the recovery process of hemiplegic patients, and the upper extremity, lower extremity, and hands are individually evaluated. A higher BMRS indicates better motor development

    Measured: at baseline, at one month and three months after treatment

Timeline

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

  1. First posted25 Jan 2024
  2. Study start15 Mar 2022
  3. Primary completion15 Jun 2023
  4. Study completion15 Jun 2023

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
Model description
Randomized Controlled
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06225024
Sponsor's protocol ID
University of Health Sciences
Status last verified
Feb 2024
First submitted
7 Jan 2024
Last updated
13 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yoldas Aslan S, Kutlay S, Dusunceli Atman E, Elhan AH, Gok H, Kucukdeveci AA. Does extracorporeal shock wave therapy decrease spasticity of ankle plantar flexor muscles in patients with stroke: A randomized controlled trial. Clin Rehabil. 2021 Oct;35(10):1442-1453. doi: 10.1177/02692155211011320. Epub 2021 Apr 28.

    PubMed 33906450

  • Yang E, Lew HL, Ozcakar L, Wu CH. Recent Advances in the Treatment of Spasticity: Extracorporeal Shock Wave Therapy. J Clin Med. 2021 Oct 14;10(20):4723. doi: 10.3390/jcm10204723.

    PubMed 34682846

Questions about this trial

What is this clinical trial studying?

A study testing ESWT and BoNT A in people with Stroke and Spasticity, Muscle, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).

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 6 inclusion and 13 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: finished, as of the sponsor's last update on 13 Feb 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 Turkey (Türkiye). 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Ashworth Scale (MAS) (time frame: at baseline, at one month and three months after treatment). 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 NCT06225024, which also lists 2 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 13 Feb 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in