Stroke, IschemicNCT05196633
Radial Extracorporeal Shock Wave Therapy and Visual Feedback Balance Training on Lower Limb Post-Stroke Spasticity, Trunk Performance and Balance:
A study testing radial extracorporeal shock wave therapy in people with Stroke, Ischemic and Stroke Hemorrhagic, run by Carol Davila University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
This study assess the relationship between lower limb spasticity and trunk movements during static and dynamic balance in post-stroke patients who also underwent conventional physical therapy, visual feedback balance training and radial extracorporeal shock wave therapy intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic, Stroke Hemorrhagic, Spasticity as Sequela of Stroke
- What is being tested?
- radial extracorporeal shock wave therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteRomania
- Study dates
- 1 Jan 2021to 31 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a hemorrhagic or ischemic stroke in acute, subacute or chronic phase;
- no history of previous stroke;
- lower limb post-stroke spasticity and spasticity grade ≥1 on the Modified Ashworth Scale (MAS);
- pain intensity measured on Visual Analogue Scale (VAS) ≥1;
- ability to stand unassisted in upright position for 30 seconds;
- no change in anti-spastic drug dose or treatment and no changes in analgesic medication, as it could affect the results on the Modified Ashworth Scale and the Visual Analogue Scale
- adult patients (>18 years old)
Who cannot join
- other neurological and orthopaedic disorders or lower limb deformities that could in-terfere with motor performance and balance;
- myopathies;
- severe cognitive impairment, severe aphasia or inability to understand instructions;
- severe spasticity;
- visual field conditions or hemineglect;
- patients unable to undergo follow-up evaluation and excluded from the final analysis;
- anticoagulant medication or any contraindication to receive radial extracorporeal shockwave therapy (rESWT), or any contraindication to physical therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Radial Extracorporeal Shock Wave Therapy and Visual Feedback Balance Training on Lower Limb Post-Stroke Spasticity, Trunk Performance and Balance: A Randomized Controlled Trial
This study assess the relationship between lower limb spasticity and trunk movements during static and dynamic balance in post-stroke patients who also underwent conventional physical therapy, visual feedback balance training and radial extracorporeal shock wave therapy intervention.
Read the detailed description
The stabilometric assessment through Prokin system complemented the clinical evaluation and provided a more objective, global insight into the combined therapeutic effect.
The stabilometric computerized system is both an assessment tool and a training system for static, dynamic balance and trunk. To date, it was used in various clinical trials as a training tool for promoting stance and balance improvement in several neurorehabilitation programs.
Additional outcomes focused on the effectiveness on pain intensity, clonus, passive range of motion, lower limb sensorimotor function, and functionality. The adverse events were also attentively monitored during the trial.
- Conditions
- Stroke, Ischemic, Stroke Hemorrhagic, Spasticity as Sequela of Stroke, Spastic Gait, Balance; Distorted
- Being tested
- radial extracorporeal shock wave therapy, sham radial extracorporeal shock wave therapy
- Keywords
- stroke, spasticity, balance trainer, balance impairment, neurologic rehabilitation
- Medical subject headings
- Ischemic Stroke, Hemorrhagic Stroke, Gait Disorders, Neurologic, Stroke, 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 therapyOther
rESWT (Endopuls 811; Enraf Nonius B.V. Va-reseweg 127, 3047 AT Rotterdam MedTech, Wessling, Germany) will be applied on the myotendinous junction of both the gastrocnemius and the soleus muscles in post-stroke spasticity patients. 2000 shots will be applied on the gastrocnemius and soleus myotendinous junction with a frequency of 10 Hz and energy density of 60 mJ (1 bar) within tolerable pain limits.
sham radial extracorporeal shock wave therapyOther
The control group will receive sound over the myotendinous junction of gastrocnemius and soleus with transducer-like contact.
| Study group | Role | What they receive |
|---|---|---|
| Conventional physiotherapy, visual feedback training, rESWT | Experimental | conventional physiotherapy (5 times/week), visual feedback training (5 times/week), radial extracorporeal shock wave therapy (once/week for 2 weeks) Receives: Other: radial extracorporeal shock wave therapy |
| Conventional physiotherapy, visual feedback training, sham rESWT | Sham comparator | conventional physiotherapy (5 times/week), visual feedback training (5 times/week), sham radial extracorporeal shock wave therapy (once/week for 2 weeks) Receives: Other: sham radial extracorporeal shock wave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spasticity grade change
The Modified Ashworth Scale (MAS)
Measured: Change from baseline Modified Ashworth Scale at 14 days
Secondary outcomes (3)
Range of motion change
passive range of motion (PROM) parameter measured through a hand-held goniometer
Measured: Change from baseline Passive Range of Motion at 14 days
Pain intensity change
Visual Analogue Scale (VAS) through a vertical 10-cm line (0 - starting pain-free to 10 - the worst imaginable pain). The higher the score means a worse outcome.
Measured: Change from baseline Visual Analogue Scale at 14 days
Stabilometric outcomes change
Prokin system (PK 252, TecnoBody, Bergamo, Italy) parameters: trunk (degrees), stance (degrees), static (mm^2) and dynamic balance (mm^2)
Measured: Change from baseline Prokin system parameters at 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start1 Jan 2021
- Primary completion30 Jun 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies 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
- Participant, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carol Davila University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emanuela Elena Mihai, Carol Davila University of Medicine and Pharmacy
- Investigators
- Mihai Berteanu, Study director, Physical and Rehabilitation Medicine Department, Elias University Emergency Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196633
- Sponsor's protocol ID
- 2090/C.E.
- Status last verified
- Dec 2024
- First submitted
- 21 Dec 2021
- Last updated
- 3 Dec 2024
- 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 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Radial Extracorporeal Shock Wave Therapy and Visual Feedback Balance Training on Lower Limb Post-Stroke Spasticity, Trunk Performance and Balance: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05196633
- Acronym / sponsor ID
- 2090/C.E.
- Conditions
- Stroke, Ischemic, Stroke Hemorrhagic, Spasticity as Sequela of Stroke, Spastic Gait, Balance; Distorted
- Keywords
- stroke, spasticity, balance trainer, balance impairment, neurologic rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Carol Davila University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 19 Jan 2022 (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.
This study assess the relationship between lower limb spasticity and trunk movements during static and dynamic balance in post-stroke patients who also underwent conventional physical therapy, visual feedback balance training and radial extracorporeal shock wave therapy intervention.
Detailed description
The stabilometric assessment through Prokin system complemented the clinical evaluation and provided a more objective, global insight into the combined therapeutic effect.
The stabilometric computerized system is both an assessment tool and a training system for static, dynamic balance and trunk. To date, it was used in various clinical trials as a training tool for promoting stance and balance improvement in several neurorehabilitation programs.
Additional outcomes focused on the effectiveness on pain intensity, clonus, passive range of motion, lower limb sensorimotor function, and functionality. The adverse events were also attentively monitored during the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional physiotherapy, visual feedback training, rESWT | Experimental | Other: radial extracorporeal shock wave therapyconventional physiotherapy (5 times/week), visual feedback training (5 times/week), radial extracorporeal shock wave therapy (once/week for 2 weeks) |
| Conventional physiotherapy, visual feedback training, sham rESWT | Sham comparator | Other: sham radial extracorporeal shock wave therapyconventional physiotherapy (5 times/week), visual feedback training (5 times/week), sham radial extracorporeal shock wave therapy (once/week for 2 weeks) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- a hemorrhagic or ischemic stroke in acute, subacute or chronic phase;
- no history of previous stroke;
- lower limb post-stroke spasticity and spasticity grade ≥1 on the Modified Ashworth Scale (MAS);
- pain intensity measured on Visual Analogue Scale (VAS) ≥1;
- ability to stand unassisted in upright position for 30 seconds;
Key exclusion criteria (7 listed)
- other neurological and orthopaedic disorders or lower limb deformities that could in-terfere with motor performance and balance;
- myopathies;
- severe cognitive impairment, severe aphasia or inability to understand instructions;
- severe spasticity;
- visual field conditions or hemineglect;
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 therapyrESWT (Endopuls 811; Enraf Nonius B.V. Va-reseweg 127, 3047 AT Rotterdam MedTech, Wessling, Germany) will be applied on the myotendinous junction of both the gastrocnemius and the soleus muscles in post-stroke spasticity patients. 2000 shots will be applied on the gastrocnemius and soleus myotendinous junction with a frequency of 10 Hz and energy density of 60 mJ (1 bar) within tolerable pain limits. | Other | Conventional physiotherapy, visual feedback training, rESWT |
| sham radial extracorporeal shock wave therapyThe control group will receive sound over the myotendinous junction of gastrocnemius and soleus with transducer-like contact. | Other | Conventional physiotherapy, visual feedback training, sham rESWT |
Primary outcome
Spasticity grade change
Time frame: Change from baseline Modified Ashworth Scale at 14 days
The Modified Ashworth Scale (MAS)
3 secondary outcomes
Range of motion change
Time frame: Change from baseline Passive Range of Motion at 14 days
Pain intensity change
Time frame: Change from baseline Visual Analogue Scale at 14 days
Stabilometric outcomes change
Time frame: Change from baseline Prokin system parameters at 14 days
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 3 Dec 2024.
- 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.
Mihai Berteanu study director
Physical and Rehabilitation Medicine Department, Elias University Emergency Hospital
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 in people with Stroke, Ischemic and Stroke Hemorrhagic, run by Carol Davila University of Medicine and Pharmacy at 1 site in Romania.
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 7 inclusion and 7 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 3 Dec 2024. 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 Romania. 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?
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?
Spasticity grade change (time frame: Change from baseline Modified Ashworth Scale at 14 days). 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 3 Dec 2024.