Spasticity, MuscleNCT04365478
Early Radial Shock Waves Treatment on Spasticity in Patients With Stroke in Sub-acute Phase
A study testing Radial Extracorporeal Shock Wave Therapy and Conventional physiotherapy in people with Spasticity, Muscle and Extracorporeal Shockwave Therapy, run by Stefano Brunelli at 1 site in Italy.
Trial summary
Hands and wrist spasticity are a common post stroke complication and often lead to restrictions in daily living activities. Spasticity causes changes in muscle composition such as accumulation of collagenous connective tissue and progressive loss of skeletal muscle fibres and these changes start almost immediately… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spasticity, Muscle, Extracorporeal Shockwave Therapy, Rehabilitation
- What is being tested?
- Radial Extracorporeal Shock Wave Therapy and Conventional physiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 2 May 2020to 27 Sep 2021
- 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
- Diagnosis of hemiparesis after an ischemic or hemorrhagic stroke
- Onset of spasticity within 3 months from acute stroke
- First-stroke survivors with confirmed brain lesions by tomography or magnetic resonance imaging
- Adults (age between 18 and 80 years)
- Post-stroke upper limb spasticity ranging 1-4 according to the Modified Ashworth Scale
Who cannot join
- No treatment of the limb spasticity with botulinum toxin, phenol, alcohol, or surgery in the last 6 months
- Presence of an unstable medical condition
- Contraindications to shock waves treatment (pregnancy, cancer, coagulopathies, pacemakers, skin pathologies)
- Global aphasia
- All subjects who scored above 25 on the Mini-Mental State Examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of an Early Radial Shock Waves Therapy on Spasticity of the Upper Limb and on Functional Outcome in Patients With Stroke in Subacute Phase
Hands and wrist spasticity are a common post stroke complication and often lead to restrictions in daily living activities. Spasticity causes changes in muscle composition such as accumulation of collagenous connective tissue and progressive loss of skeletal muscle fibres and these changes start almost immediately after a vascular event. Radial Shock Wave Therapy (rSWT) is a valid alternative rehabilitating tool in managing chronic spasticity but no study has so far investigated the effect in a recently onset hemiparesis. The aim of this study is to evaluate the efficacy of an early radial shock wave therapy in improving spasticity of the upper limb in patients with a recent onset stroke. The secondary outcome is to investigate the improvement of upper limb motor functionality, passive range of motion and joint pain and to determine if it can lead to a better performance in daily living activities. This study is a randomized controlled trial double arm single blind. The investigators plan to enrol 40 hemiplegic patients with sub-acute stroke and randomly assign them to an experimental or control group. The experimental group (EG) will perform one radial shock wave therapy session a week for 8 weeks administered during the daily morning 40 minutes of conventional rehabilitation treatment. The control group (CG) 40-minutes of conventional rehabilitation treatment for 5 days per week in the morning for 8 weeks. All patients performed in the afternoon a second daily session of 40 minutes of conventional rehabilitation therapy 5 days per week. The Modified Ashworth Scale (MAS), Fugl-Meyer Assessment Upper Extremity (FMA-UE) (with motricity, Passive Range of Motion (PROM) and pain sub-scores of upper extremity part of the scale), Modified Barthel Index and Visual Analogue Scale (VAS) for patient's benefit perceived, will be evaluated before and a week after the last intervention. MAS will be administered once a week, before rSWT treatment. The investigators plan to have a 1 month follow up during which every outcome measure will be administered. The investigators hypothesize that radial shock waves therapy, started early and associated with traditional physiotherapy, may be more effective in promoting the reduction of spasticity and pain of the upper limb, improve its functionality and therefore a reduction in disability, compared to conventional rehabilitation treatment. A reduction in the use of analgesic and muscle relaxants drugs is also conceivable
- Being tested
- Radial Extracorporeal Shock Wave Therapy, Conventional physiotherapy
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial Extracorporeal Shock Wave TherapyProcedure or surgery
rSWT group: One radial shock wave therapy session a week for 8 weeks (parameters: 1.5 bar, 10 Hz, 2000 shots for each muscle group treated) administered daily during the morning for 40 minutes of conventional rehabilitation treatment.
Conventional physiotherapyProcedure or surgery
Control group: 40-minutes of conventional rehabilitation treatment 5 days per week in the morning (strength exercise, trunk control exercise, stretching exercise, occupational therapy, and neurodevelopmental facilitation techniques) for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| rSWT group | Experimental | Radial Extracorporeal Shock Wave Therapy on spastic muscles of upper limb Receives: Procedure: Radial Extracorporeal Shock Wave Therapy |
| Control group | Active comparator | conventional physiotherapy Receives: Procedure: Conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Modified Ashworth Scale at 9 weeks and at 13 weeks
A 6-point scale grading the resistance of a relaxed limb to rapid passive stretch
Measured: baseline the first rSWT treatment, at 9 weeks (1 week after the last treatment) and at 13 weeks (follow up at 4 weeks after the last treatment)
Secondary outcomes (3)
Change from baseline FUGL-MEYER ASSESSMENT UPPER EXTREMITY (FMA-UE) at 9 weeks and at 13 weeks
It is designed to assess motor functioning, sensation, pain and joint functioning in patients with post-stroke hemiplegia.
Measured: baseline the first rSWT treatment, at 9 weeks (1 week after the last treatment) and at 13 weeks (follow up at 4 weeks after the last treatment)
Change from baseline Barthel Index at 9 weeks and at 13 weeks
it is a 10-item ordinal scale that cover mobility and self-care domains; scores range from 0 (total dependence in ADL) to 100 (complete independence)
Measured: baseline the first rSWT treatment, at 9 weeks (1 week after the last treatment) and at 13 weeks (follow up at 4 weeks after the last treatment)
visual analogue scale (VAS)
to rate their degree of perceived benefit from treatment
Measured: at 9 weeks (at the end of the last rESWT treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start2 May 2020
- Primary completion20 Sep 2021
- Study completion27 Sep 2021
Why it stopped: The study was suspended due to difficulties in recalling participants to follow up due to restrictions related to the COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spasticity, MuscleStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stefano Brunelli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stefano Brunelli, I.R.C.C.S. Fondazione Santa Lucia
- Investigators
- Noemi Gentileschi, MD, Principal investigator, Fondazione Santa Lucia Roma Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365478
- Sponsor's protocol ID
- Prot. CE/PROG.768 FSL
- Status last verified
- Mar 2022
- First submitted
- 20 Apr 2020
- Last updated
- 1 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
Publications
Sommerfeld DK, Eek EU, Svensson AK, Holmqvist LW, von Arbin MH. Spasticity after stroke: its occurrence and association with motor impairments and activity limitations. Stroke. 2004 Jan;35(1):134-9. doi: 10.1161/01.STR.0000105386.05173.5E. Epub 2003 Dec 18.
PubMed 14684785Lee SS, Spear S, Rymer WZ. Quantifying changes in material properties of stroke-impaired muscle. Clin Biomech (Bristol). 2015 Mar;30(3):269-75. doi: 10.1016/j.clinbiomech.2015.01.004. Epub 2015 Jan 21.
PubMed 25638688Manganotti P, Amelio E. Long-term effect of shock wave therapy on upper limb hypertonia in patients affected by stroke. Stroke. 2005 Sep;36(9):1967-71. doi: 10.1161/01.STR.0000177880.06663.5c. Epub 2005 Aug 18.
PubMed 16109905
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Early Radial Shock Waves Therapy on Spasticity of the Upper Limb and on Functional Outcome in Patients With Stroke in Subacute Phase
- ClinicalTrials.gov ID
- NCT04365478
- Acronym / sponsor ID
- Prot. CE/PROG.768 FSL
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was suspended due to difficulties in recalling participants to follow up due to restrictions related to the COVID-19 pandemic
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Stefano BrunelliUniversity, hospital or other
- Study start
- 2 May 2020 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 27 Sep 2021 (actual)
- First posted
- 28 Apr 2020 (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.
Hands and wrist spasticity are a common post stroke complication and often lead to restrictions in daily living activities. Spasticity causes changes in muscle composition such as accumulation of collagenous connective tissue and progressive loss of skeletal muscle fibres and these changes start almost immediately after a vascular event. Radial Shock Wave Therapy (rSWT) is a valid alternative rehabilitating tool in managing chronic spasticity but no study has so far investigated the effect in a recently onset hemiparesis. The aim of this study is to evaluate the efficacy of an early radial shock wave therapy in improving spasticity of the upper limb in patients with a recent onset stroke. The secondary outcome is to investigate the improvement of upper limb motor functionality, passive range of motion and joint pain and to determine if it can lead to a better performance in daily living activities. This study is a randomized controlled trial double arm single blind. The investigators plan to enrol 40 hemiplegic patients with sub-acute stroke and randomly assign them to an experimental or control group. The experimental group (EG) will perform one radial shock wave therapy session a week for 8 weeks administered during the daily morning 40 minutes of conventional rehabilitation treatment. The control group (CG) 40-minutes of conventional rehabilitation treatment for 5 days per week in the morning for 8 weeks. All patients performed in the afternoon a second daily session of 40 minutes of conventional rehabilitation therapy 5 days per week. The Modified Ashworth Scale (MAS), Fugl-Meyer Assessment Upper Extremity (FMA-UE) (with motricity, Passive Range of Motion (PROM) and pain sub-scores of upper extremity part of the scale), Modified Barthel Index and Visual Analogue Scale (VAS) for patient's benefit perceived, will be evaluated before and a week after the last intervention. MAS will be administered once a week, before rSWT treatment. The investigators plan to have a 1 month follow up during which every outcome measure will be administered. The investigators hypothesize that radial shock waves therapy, started early and associated with traditional physiotherapy, may be more effective in promoting the reduction of spasticity and pain of the upper limb, improve its functionality and therefore a reduction in disability, compared to conventional rehabilitation treatment. A reduction in the use of analgesic and muscle relaxants drugs is also conceivable
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rSWT group | Experimental | Procedure: Radial Extracorporeal Shock Wave TherapyRadial Extracorporeal Shock Wave Therapy on spastic muscles of upper limb |
| Control group | Active comparator | Procedure: Conventional physiotherapyconventional physiotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of hemiparesis after an ischemic or hemorrhagic stroke
- Onset of spasticity within 3 months from acute stroke
- First-stroke survivors with confirmed brain lesions by tomography or magnetic resonance imaging
- Adults (age between 18 and 80 years)
- Post-stroke upper limb spasticity ranging 1-4 according to the Modified Ashworth Scale
Key exclusion criteria (5 listed)
- No treatment of the limb spasticity with botulinum toxin, phenol, alcohol, or surgery in the last 6 months
- Presence of an unstable medical condition
- Contraindications to shock waves treatment (pregnancy, cancer, coagulopathies, pacemakers, skin pathologies)
- Global aphasia
- All subjects who scored above 25 on the Mini-Mental State Examination
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 |
|---|---|---|
| Radial Extracorporeal Shock Wave TherapyrSWT group: One radial shock wave therapy session a week for 8 weeks (parameters: 1.5 bar, 10 Hz, 2000 shots for each muscle group treated) administered daily during the morning for 40 minutes of conventional rehabilitation treatment. | Procedure or surgery | rSWT group |
| Conventional physiotherapyControl group: 40-minutes of conventional rehabilitation treatment 5 days per week in the morning (strength exercise, trunk control exercise, stretching exercise, occupational therapy, and neurodevelopmental facilitation techniques) for 8 weeks | Procedure or surgery | Control group |
Primary outcome
Change from baseline Modified Ashworth Scale at 9 weeks and at 13 weeks
Time frame: baseline the first rSWT treatment, at 9 weeks (1 week after the last treatment) and at 13 weeks (follow up at 4 weeks after the last treatment)
A 6-point scale grading the resistance of a relaxed limb to rapid passive stretch
3 secondary outcomes
Change from baseline FUGL-MEYER ASSESSMENT UPPER EXTREMITY (FMA-UE) at 9 weeks and at 13 weeks
Time frame: baseline the first rSWT treatment, at 9 weeks (1 week after the last treatment) and at 13 weeks (follow up at 4 weeks after the last treatment)
Change from baseline Barthel Index at 9 weeks and at 13 weeks
Time frame: baseline the first rSWT treatment, at 9 weeks (1 week after the last treatment) and at 13 weeks (follow up at 4 weeks after the last treatment)
visual analogue scale (VAS)
Time frame: at 9 weeks (at the end of the last rESWT treatment)
Results and safety
The study was stopped early (reason given: The study was suspended due to difficulties in recalling participants to follow up due to restrictions related to the COVID-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Background: PubMed 14684785Sommerfeld DK, Eek EU, Svensson AK, Holmqvist LW, von Arbin MH. Spasticity after stroke: its occurrence and association with motor impairments and activity limitations. Stroke. 2004 Jan;35(1):134-9. doi: 10.1161/01.STR.0000105386.05173.5E. Epub 2003 Dec 18.
- Background: PubMed 25638688Lee SS, Spear S, Rymer WZ. Quantifying changes in material properties of stroke-impaired muscle. Clin Biomech (Bristol). 2015 Mar;30(3):269-75. doi: 10.1016/j.clinbiomech.2015.01.004. Epub 2015 Jan 21.
- Background: PubMed 16109905Manganotti P, Amelio E. Long-term effect of shock wave therapy on upper limb hypertonia in patients affected by stroke. Stroke. 2005 Sep;36(9):1967-71. doi: 10.1161/01.STR.0000177880.06663.5c. Epub 2005 Aug 18.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
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Spasticity, Stroke
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.
Noemi Gentileschi, MD principal investigator
Fondazione Santa Lucia Roma Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radial Extracorporeal Shock Wave Therapy and Conventional physiotherapy in people with Spasticity, Muscle and Extracorporeal Shockwave Therapy, run by Stefano Brunelli at 1 site in Italy.
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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 1 Apr 2022. 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 Italy. 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 was stopped early (reason given: The study was suspended due to difficulties in recalling participants to follow up due to restrictions related to the COVID-19 pandemic). Results are not available in the source record.
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 Modified Ashworth Scale at 9 weeks and at 13 weeks (time frame: baseline the first rSWT treatment, at 9 weeks (1 week after the last treatment) and at 13 weeks (follow up at 4 weeks after the last treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04365478, which also lists 3 linked publications.
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 1 Apr 2022.