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

NCT ID: NCT03129529

Last Updated: 2017-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2017-01-01

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.

Conditions

Spasticity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

focused shock wave

Treatment was administered directly to the middle of muscle bellies of the spastic triceps surae muscle in three sessions, with one week interval. During each session, 3000 pulses (1500 shots in the gastrocnemius and 1500 shots in the soleus muscle) were delivered at 5 Hz. The intensities of FSWT were 0.10 mJ/mm2.

Group Type: EXPERIMENTAL

Focused shock wave

Intervention Type: DEVICE

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

radial shock wave

Treatment was administered directly to the middle of muscle bellies of the spastic triceps surae muscle in three sessions, with one week interval. During each session, 3000 pulses (1500 shots in the gastrocnemius and 1500 shots in the soleus muscle) were delivered at 5 Hz.The intensities of RSWT were 2.0 bar.

Group Type: EXPERIMENTAL

Radial shock wave

Intervention Type: DEVICE

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

Interventions

Focused shock wave

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

Intervention Type: DEVICE

Radial shock wave

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mackay Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gwo-Chi Hu,PHD

PHD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mackay Memorial Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

15MMHIS194e

Identifier Type: -

Identifier Source: org_study_id