SpasticityNCT03129529
Comparing the Effect of Focused and Radial Extracorporeal Shock Waves on Post-stroke Hypertonia
A study testing Focused shock wave and Radial shock wave in people with Spasticity, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spasticity
- What is being tested?
- Focused shock wave and Radial shock wave
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2016to 1 Jan 2017
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Exclusion criteria included fixed ankle joint contracture, previous treatment of the affected leg with neurolytic or surgical procedures, concomitant progressive central nervous system diseases, and skin breakdown, vascular disease in the affected leg
Trial locations and contacts
1 site in 1 country.
About this study
The main purpose of this study is to compare treatment efficacy of focused and radial extracorporeal shock waves on spasticity in chronic stroke patient
Read the 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
- Being tested
- Focused shock wave, Radial shock wave
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused shock waveDevice
The outcome evaluation include ankle range of motion (ROM), modified Ashworth scale (MAS),modified Tardieu scale (MTS), baropodometric measurement, and gait speed.
Radial shock waveDevice
The outcome evaluation include ankle range of motion (ROM), modified Ashworth scale (MAS),modified Tardieu scale (MTS), baropodometric measurement, and gait speed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Radial shock wave |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1, 4, 8 week
Secondary outcomes (4)
Change from baseline of range of motion on 1st, 4th, 8th weeks after treatment.
Using the digital goniometer to measure the passive range of motion before treatment and multiple time frame after treatment.
Measured: 1, 4, 8 week
Change from baseline of modified Tardieu scale on 1st, 4th, 8th weeks after treatment.
Using the modified Tardieu scale (MTS) to measure the spasticity before treatment and multiple time frame after treatment.
Measured: 1, 4, 8 week
Change from baseline of foot contact area on 1st, 4th, 8th weeks after treatment.
Using the baropodometric measurement to measure the foot contact area before treatment and multiple time frame after treatment.
Measured: 1, 4, 8 week
Change from baseline of gait speed on 8th weeks after treatment.
Using the 10 meters walking test to measure the gait speed before treatment and after treatment.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start1 Jan 2016
- Primary completion1 Mar 2016
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpasticityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gwo-Chi Hu,PHD, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03129529
- Sponsor's protocol ID
- 15MMHIS194e
- Status last verified
- Apr 2017
- First submitted
- 20 Apr 2017
- Last updated
- 26 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effect of Focused and Radial Extracorporeal Shock Waves on Post-stroke Hypertonia
- ClinicalTrials.gov ID
- NCT03129529
- Acronym / sponsor ID
- 15MMHIS194e
- Conditions
- Spasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Mar 2016 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 26 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| focused shock wave | Experimental | Device: Focused shock waveTreatment 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. |
| radial shock wave | Experimental | Device: Radial shock waveTreatment 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Exclusion criteria included fixed ankle joint contracture, previous treatment of the affected leg with neurolytic or surgical procedures, concomitant progressive central nervous system diseases, and skin breakdown, vascular disease in the affected leg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focused shock waveThe outcome evaluation include ankle range of motion (ROM), modified Ashworth scale (MAS),modified Tardieu scale (MTS), baropodometric measurement, and gait speed. | Device | focused shock wave |
| Radial shock waveThe outcome evaluation include ankle range of motion (ROM), modified Ashworth scale (MAS),modified Tardieu scale (MTS), baropodometric measurement, and gait speed. | Device | radial shock wave |
Primary outcome
Change from baseline of spasticity on 1st, 4th, 8th weeks after treatment.
Time frame: 1, 4, 8 week
Using the modyfied Ashworth Scale to measure the spasticity before treatment and multiple time frame after treatment.
4 secondary outcomes
Change from baseline of range of motion on 1st, 4th, 8th weeks after treatment.
Time frame: 1, 4, 8 week
Change from baseline of modified Tardieu scale on 1st, 4th, 8th weeks after treatment.
Time frame: 1, 4, 8 week
Change from baseline of foot contact area on 1st, 4th, 8th weeks after treatment.
Time frame: 1, 4, 8 week
Change from baseline of gait speed on 8th weeks after treatment.
Time frame: 8 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused shock wave and Radial shock wave in people with Spasticity, run by Mackay Memorial Hospital at 1 site in Taiwan.
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 4 inclusion and 1 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 26 Apr 2017. 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 Taiwan. 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?
Change from baseline of spasticity on 1st, 4th, 8th weeks after treatment. (time frame: 1, 4, 8 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Apr 2017.