Comparing the Effect of Focused and Radial Extracorporeal Shock Waves on Post-stroke Hypertonia

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03129529

Enrollment

Registered

2017-04-26

Start date

2016-01-01

Completion date

2017-01-01

Last updated

2017-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spasticity

Brief summary

The main purpose of this study is to compare treatment efficacy of focused and radial extracorporeal shock waves on spasticity in chronic stroke patient

Detailed description

This study is a prospective and double-blinded randomized control trial. Thirty-two stroke patients with spastic equinus were randomly assigned to receive three sessions of either focused shockwave therapy or radial shockwave therapy at 1-week intervals. The intensities that were used during FSWT (0.1 mJ/mm2) and RSWT (2 bar) were comparable. Patients were evaluated at baseline and at 1, 4, 8 weeks after the final shockwave treatment. The primary outcome measure was modified Ashworth scale (MAS) score. Secondary outcome measures were Tardieu scale, ankle passive range of motion, plantar contact area during gait, and gait speed. A linear mixed model with repeated measures was used to compare each outcome measure between the two groups.

Interventions

DEVICEFocused shock wave

The outcome evaluation include ankle range of motion (ROM), modified Ashworth scale (MAS),modified Tardieu scale (MTS), baropodometric measurement, and gait speed.

DEVICERadial shock wave

The outcome evaluation include ankle range of motion (ROM), modified Ashworth scale (MAS),modified Tardieu scale (MTS), baropodometric measurement, and gait speed.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* aged greater than 18 years old; * at least 6 months since onset of last stroke; * triceps surae muscle tone graded at least 1+ on the Modified Ashworth Scale (MAS) score; * ability to walk alone with/without orthosis.

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline of spasticity on 1st, 4th, 8th weeks after treatment.	1, 4, 8 week	Using the modyfied Ashworth Scale to measure the spasticity before treatment and multiple time frame after treatment.

Secondary

Measure	Time frame	Description
Change from baseline of range of motion on 1st, 4th, 8th weeks after treatment.	1, 4, 8 week	Using the digital goniometer to measure the passive range of motion before treatment and multiple time frame after treatment.
Change from baseline of modified Tardieu scale on 1st, 4th, 8th weeks after treatment.	1, 4, 8 week	Using the modified Tardieu scale (MTS) to measure the spasticity before treatment and multiple time frame after treatment.
Change from baseline of foot contact area on 1st, 4th, 8th weeks after treatment.	1, 4, 8 week	Using the baropodometric measurement to measure the foot contact area before treatment and multiple time frame after treatment.
Change from baseline of gait speed on 8th weeks after treatment.	8 week	Using the 10 meters walking test to measure the gait speed before treatment and after treatment.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026