StrokeNCT04316026
Effectiveness of Shock Wave Therapy for Upper Limb Spasticity
A study testing shock wave therapy in people with Stroke, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Introduction: Shock wave therapy (SWT) has a potential interest to treat spasticity. However, the pathophysiology of this treatment remains unknown. Some authors assert that it is effective on spasticity itself, while others suggest that it acts more on fibrosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- shock wave therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Sep 2019to Jun 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of cerebral lesion
- Wrist spasticity ≥ 1+/4 on the Modified Ashworth Scale
- Wrist spasticity ≥ 2/4 on the Tardieu Scale
- Passive dorsal extension of the wrist ≥ 10°
Who cannot join
- Botulinum toxin injection in the upper limb in the past three months
- History of wrist arthrodesis
- Myopathy
- Treatment with oral anticoagulants or coagulation disease
- Tumor or infection of the paretic upper limb
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques universitaires Saint-Luc
Brussels, 1200
Gaëtan Stoquart, MD PhD, +327641650, gaetan.stoquart@uclouvain.be
Clara Selves, MD, +327641650, clara.selves@uclouvain.be
About this study
Official title: Effectiveness of Shock Wave Therapy to Treat Upper Limb Spasticity in Hemiparetic Patients
Introduction: Shock wave therapy (SWT) has a potential interest to treat spasticity. However, the pathophysiology of this treatment remains unknown. Some authors assert that it is effective on spasticity itself, while others suggest that it acts more on fibrosis.
Method: this study will assess the effectiveness of radial SWT to treat wrist and finger flexors stiffness in stroke patients, comparing subacute spastic patients (< 12 months) with chronic patients presenting muscle contractures (> 12 months). Forty-eight stroke patients (24 in the subacute phase and 24 in the chronic phase) will be included. One real and one sham sessions of SWT will be performed with a 2-week interval. The order of the sessions will be randomized. Motor control, stiffness and spasticity will be assessed with clinical and objective measures, just after and just before each session, by a blind assessor. The targeted muscles will be flexor carpi radialis, flexor carpi ulnaris and flexor digitorum profundus, and will be the same for the two session.
- Conditions
- Stroke
- Being tested
- shock wave therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shock wave therapyDevice
Shockwave therapy is a non-invasive treatment creating a series of low energy acoustic wave pulsations that are directly applied through the skin via a gel medium
| Study group | Role | What they receive |
|---|---|---|
| interventional group | Experimental | group receiving shock wave therapy Receives: Device: shock wave therapy |
| control group | Sham comparator | sham shock wave therapy Receives: Device: shock wave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale
Clinical assessment of spasticity for wrist and fingers flexors, score from 0 to 4 (a higher score representing a greater spasticity)
Measured: Before (baseline) and 5 minutes (post-treatment) after each of the two sessions (sham or real SWT)
Tardieu scale
Clinical assessment of spasticity for wrist and fingers flexors; score from 0 to 4 (a higher score representing a greater spasticity)
Measured: Before (baseline) and 5 minutes (post-treatment) after each of the two sessions (sham or real SWT)
Secondary outcomes (11)
objective measure of elastic and viscous stiffness of the wrist, expressed in N.m.rad
electronic oscillatory device for stiffness measurement
Measured: Before (baseline) and 5 minutes (post-treatment) after each of the two sessions (sham or real SWT)
objective measure of muscle stiffness
Myoton measurement device
Measured: Before (baseline) and 10 minutes (post-treatment) after each of the two sessions (sham or real SWT)
manual goniometer
Passive measure of joint range of motion
Measured: Before (baseline) and 10 minutes (post-treatment) after each of the two sessions (sham or real SWT)
Medical Research Council muscle testing
strength assessment; score from 0 to 5 (a higher score representing a greater strength)
Measured: Before (baseline) and 25 minutes (post-treatment) after each of the two sessions (sham or real SWT)
Isokinetic dynamometer
objective measure of muscle stiffness at the wrist
Measured: Before (baseline) and 15 minutes (post-treatment) after each of the two sessions (sham or real SWT)
H reflex
electrophysiological assessment of the H reflex (motoneuronal excitability)
Measured: Before (baseline) and 5 minutes (post-treatment) after each of the two sessions (sham or real SWT)
Box and block test
measure of manual ability
Measured: Before (baseline) and 30 minutes (post-treatment) after each of the two sessions (sham or real SWT)
Fugl Meyer Assessment - computerized adaptive testing
neurological impairment
Measured: Before (baseline) and 25 minutes (post-treatment) after each of the two sessions (sham or real SWT)
Abilhand scale
PROMS on bimanual activities; a higher score represents a better manual ability
Measured: Before (baseline) and 45 minutes (post-treatment) after each of the two sessions (sham or real SWT)
Wolff Motor Function Test
manual activities
Measured: Before (baseline) and 35 minutes (post-treatment) after each of the two sessions (sham or real SWT)
Visual Analog Scale
patient self-assessment of overall effectiveness of SWT; score from 0 to 4 (a higher score representing a greater improvement)
Measured: Before (baseline) and 45 minutes (post-treatment) after each of the two sessions (sham or real SWT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start2 Sep 2019
- Primary completionDec 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gaëtan Stoquart, MD, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316026
- Sponsor's protocol ID
- 2019/27MAR/151
- Status last verified
- Apr 2023
- First submitted
- 7 Jan 2020
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Shock Wave Therapy to Treat Upper Limb Spasticity in Hemiparetic Patients
- ClinicalTrials.gov ID
- NCT04316026
- Acronym / sponsor ID
- 2019/27MAR/151
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 20 Mar 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.
Introduction: Shock wave therapy (SWT) has a potential interest to treat spasticity. However, the pathophysiology of this treatment remains unknown. Some authors assert that it is effective on spasticity itself, while others suggest that it acts more on fibrosis.
Method: this study will assess the effectiveness of radial SWT to treat wrist and finger flexors stiffness in stroke patients, comparing subacute spastic patients (< 12 months) with chronic patients presenting muscle contractures (> 12 months). Forty-eight stroke patients (24 in the subacute phase and 24 in the chronic phase) will be included. One real and one sham sessions of SWT will be performed with a 2-week interval. The order of the sessions will be randomized. Motor control, stiffness and spasticity will be assessed with clinical and objective measures, just after and just before each session, by a blind assessor. The targeted muscles will be flexor carpi radialis, flexor carpi ulnaris and flexor digitorum profundus, and will be the same for the two session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interventional group | Experimental | Device: shock wave therapygroup receiving shock wave therapy |
| control group | Sham comparator | Device: shock wave therapysham shock wave therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of cerebral lesion
- Wrist spasticity ≥ 1+/4 on the Modified Ashworth Scale
- Wrist spasticity ≥ 2/4 on the Tardieu Scale
- Passive dorsal extension of the wrist ≥ 10°
Key exclusion criteria (5 listed)
- Botulinum toxin injection in the upper limb in the past three months
- History of wrist arthrodesis
- Myopathy
- Treatment with oral anticoagulants or coagulation disease
- Tumor or infection of the paretic upper limb
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 |
|---|---|---|
| shock wave therapyShockwave therapy is a non-invasive treatment creating a series of low energy acoustic wave pulsations that are directly applied through the skin via a gel medium | Device | control group, interventional group |
Primary outcome
Modified Ashworth Scale
Time frame: Before (baseline) and 5 minutes (post-treatment) after each of the two sessions (sham or real SWT)
Clinical assessment of spasticity for wrist and fingers flexors, score from 0 to 4 (a higher score representing a greater spasticity)
Tardieu scale
Time frame: Before (baseline) and 5 minutes (post-treatment) after each of the two sessions (sham or real SWT)
Clinical assessment of spasticity for wrist and fingers flexors; score from 0 to 4 (a higher score representing a greater spasticity)
11 secondary outcomes
objective measure of elastic and viscous stiffness of the wrist, expressed in N.m.rad
Time frame: Before (baseline) and 5 minutes (post-treatment) after each of the two sessions (sham or real SWT)
objective measure of muscle stiffness
Time frame: Before (baseline) and 10 minutes (post-treatment) after each of the two sessions (sham or real SWT)
manual goniometer
Time frame: Before (baseline) and 10 minutes (post-treatment) after each of the two sessions (sham or real SWT)
Medical Research Council muscle testing
Time frame: Before (baseline) and 25 minutes (post-treatment) after each of the two sessions (sham or real SWT)
Isokinetic dynamometer
Time frame: Before (baseline) and 15 minutes (post-treatment) after each of the two sessions (sham or real SWT)
H reflex
Time frame: Before (baseline) and 5 minutes (post-treatment) after each of the two sessions (sham or real SWT)
Box and block test
Time frame: Before (baseline) and 30 minutes (post-treatment) after each of the two sessions (sham or real SWT)
Fugl Meyer Assessment - computerized adaptive testing
Time frame: Before (baseline) and 25 minutes (post-treatment) after each of the two sessions (sham or real SWT)
Abilhand scale
Time frame: Before (baseline) and 45 minutes (post-treatment) after each of the two sessions (sham or real SWT)
Wolff Motor Function Test
Time frame: Before (baseline) and 35 minutes (post-treatment) after each of the two sessions (sham or real SWT)
Visual Analog Scale
Time frame: Before (baseline) and 45 minutes (post-treatment) after each of the two sessions (sham or real SWT)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Gaëtan Stoquart, MD, PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing shock wave therapy in people with Stroke, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 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: status not confirmed, as of the sponsor's last update on 13 Apr 2023. 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 Belgium. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gaëtan Stoquart, MD PhD (+3227641650, gaetan.stoquart@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Ashworth Scale (time frame: Before (baseline) and 5 minutes (post-treatment) after each of the two sessions (sham or real SWT)). The study lists 2 primary outcomes in all. 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 13 Apr 2023.