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

NCT03129529 | Completed

• 1 other identifier: 15MMHIS194e
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Spasticity

Outcome Measures

Primary Outcomes (1)

• Change from baseline of spasticity on 1st, 4th, 8th weeks after treatment.

  Using the modyfied Ashworth Scale to measure the spasticity before treatment and multiple time frame after treatment.

  1, 4, 8 week

Secondary Outcomes (4)

• Change from baseline of range of motion on 1st, 4th, 8th weeks after treatment.

  1, 4, 8 week

• Change from baseline of modified Tardieu scale on 1st, 4th, 8th weeks after treatment.

  1, 4, 8 week

• Change from baseline of foot contact area on 1st, 4th, 8th weeks after treatment.

  1, 4, 8 week

• Change from baseline of gait speed on 8th weeks after treatment.

  8 week

Study Arms (2)

focused shock wave

EXPERIMENTAL

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.

Device: Focused shock wave

radial shock wave

EXPERIMENTAL

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.

Device: Radial shock wave

Interventions

Focused shock wave DEVICE

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

focused shock wave

Radial shock wave 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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Mackay Memorial Hospital: lead

Study Sites (1)

Mackay Memorial Hospital

Taipei, 104, Taiwan

Location

MeSH Terms

Conditions

Muscle Spasticity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: April 26, 2017
• Study Start: January 1, 2016
• Primary Completion: March 1, 2016
• Study Completion: January 1, 2017
• Last Updated: April 26, 2017

Record last verified: 2017-04

Locations

TW (1)