NCT05889026

Brief Summary

There are few studies on whether botulinum toxin treatment and extracorporeal shock wave therapy are more effective than botulinum toxin alone treatment for post-stroke spasticity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 6, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2021

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
Last Updated

June 5, 2023

Status Verified

May 1, 2023

Enrollment Period

1.1 years

First QC Date

May 9, 2023

Last Update Submit

May 25, 2023

Conditions

StrokeHemiplegia, SpasticMuscle Spasticity

Outcome Measures

Primary Outcomes (3)

  • Modified ashworth scale of upper extremities spasticity

    minimum grade 0, maximum grade 4 / higher grade means severe spasticity

    Pre-treatment (baseline)

  • Modified ashworth scale of upper extremities spasticity

    minimum grade 0, maximum grade 4 / higher grade means severe spasticity

    Three weeks after treatment

  • Modified ashworth scale of upper extremities spasticity

    minimum grade 0, maximum grade 4 / higher grade means severe spasticity

    Three months after treatment

Secondary Outcomes (11)

  • Modified tardieu scale of upper extremities spasticity

    Pre-treatment (baseline)

  • Modified tardieu scale of upper extremities spasticity

    Three weeks after treatment

  • Modified tardieu scale of upper extremities spasticity

    Three months after treatment

  • Fugl-Meyer assessment of upper extremity Fugl-Meyer assessment of upper extremity Fugl-Meyer assessment of upper extremity Fugl-Meyer assessment of upper extremity

    Pre-treatment (baseline)

  • Fugl-Meyer assessment of upper extremity

    Three months after treatment

  • +6 more secondary outcomes

Study Arms (2)

Botulinum toxin treatment with extracorporeal shock wave therapy

ACTIVE COMPARATOR

Nabota® (Daewoong Pharmaceutical Co. Ltd., Seoul, Korea) was used. It was diluted with 0.9% sodium chloride solution and injected into the bellies of the upper-extremity muscles. ESWT was performed immediately after botulinum toxin injection and was performed once a day for 5 days. Three weeks and 3 months after ESWT, spasticity was evaluated.

Device: Extracorporeal shock wave therapyProcedure: Botulinum toxin treatment

Botulinum toxin treatment only

SHAM COMPARATOR

Nabota® (Daewoong Pharmaceutical Co. Ltd., Seoul, Korea) was used. It was diluted with 0.9% sodium chloride solution and injected into the bellies of the upper-extremity muscles. Three weeks and 3 months after Botox treatment, spasticity was evaluated.

Procedure: Botulinum toxin treatment

Interventions

Extracorporeal shock wave therapyDEVICE

Stimulation was given to the brachial muscle, 1000 times, 4Hz, and energy flux density was 0.030mJ/mm2.

Botulinum toxin treatment with extracorporeal shock wave therapy
Botulinum toxin treatmentPROCEDURE

The toxin dose was established for each patient: it ranged between 80 unit and 300 unit.

Botulinum toxin treatment onlyBotulinum toxin treatment with extracorporeal shock wave therapy

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least 6 weeks after stroke diagnosis
  • upper-extremity (elbow, wrist and finger) spasticity Modified Ashworth Scale (MAS) score \> 2
  • ability to stand and walk safely without help or assistance

You may not qualify if:

  • improper indication for botulinum toxin A (BTxA) injection, for example, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, and motor neuropathy
  • previous contracture and/or deformity of the upper extremities
  • concurrent peripheral neuropathy and/or myopathy
  • difficulty in participating in the study due to cognitive impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea university guro hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

StrokeHemiplegiaMuscle Spasticity

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular Manifestations

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2023

First Posted

June 5, 2023

Study Start

August 6, 2020

Primary Completion

September 8, 2021

Study Completion

September 8, 2021

Last Updated

June 5, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)