Stroke, IschemicNCT05206240
Extracorporeal Shock Wave Therapy and Assessment Strategy Through a Novel Gait Analysis Tool for Post-stroke Spasticity
An observational study of Stroke, Ischemic and Stroke Hemorrhagic, run by Carol Davila University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
The aim of this study is to objectively evaluate the effectiveness of radial extracorporeal shock wave therapy (rESWT) and conventional physical therapy program on the gait pattern through a new gait analysis system which encompasses spatiotemporal and kinematic parameters and to correlate the findings with the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic, Stroke Hemorrhagic, Spasticity, Muscle
- What is being tested?
- Radial extracorporeal shock wave therapy and conventional physical therapy
- How many people
- 15 participants
- Where
- 1 siteRomania
- Study dates
- 1 Mar 2021to 1 Aug 2022
- Phase
- Observational
- 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
Study population: Inpatients from the Physical and Rehabilitation Medicine Department stating the eligibility criteria
Who may be able to join
- suffered from a hemorrhagic or ischemic stroke and they were in the subacute or chronic phase;
- had no history of previous stroke;
- had 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 and walk unassisted for at least 30 seconds;
- adult patients (>18 years old).
Who cannot join
- other neurological, musculoskeletal, orthopaedic, or cardiovascular conditions; -- severe cognitive impairment, severe aphasia or inability to understand or execute instructions;
- changes in antispastic medication and dose or changes in the analgesic medication;
- myopathy;
- severe spasticity grade;
- visual field disorders or hemineglect;
- anticoagulants or any contraindication to receive radial extracorporeal shock wave therapy (rESWT), or any contraindication to receive physical therapy sessions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Extracorporeal Shock Wave Therapy and Assessment Strategy Through a Novel Gait Analysis Tool for Post-stroke Spasticity During COVID-19 Pandemic
The aim of this study is to objectively evaluate the effectiveness of radial extracorporeal shock wave therapy (rESWT) and conventional physical therapy program on the gait pattern through a new gait analysis system which encompasses spatiotemporal and kinematic parameters and to correlate the findings with the clinical evaluation.
Read the detailed description
The aim of this observational study was to objectively evaluate the effects of radial extracorporeal shock wave therapy and conventional physical therapy program on the gait pattern, spatiotemporal variables (step length, step cycle time, stance foot flexion-extension, foot stance pronation-supination, and foot swing flexion-extension), and kinematic parameters (trunk flexion-extension, trunk lateral flexion, hip flexion-extension, knee flexion-extension, ankle flexion-extension) through a new gait analysis system and correlate the findings with clinical outcomes such as Modified Ashworth scale (MAS), passive range of motion (PROM), Clonus score, Visual Analogue Scale (VAS), Tinetti Assessment Tool, Functional Ambulation Categories (FAC).
The gait pattern of post-stroke patients before and after rESWT delivery and conventional rehabilitation program will be assessed clinically and also through an instrumented treadmill (Walker View) in terms of spatiotemporal and kinematic gait parameters.
- Conditions
- Stroke, Ischemic, Stroke Hemorrhagic, Spasticity, Muscle, Spastic Gait
- Being tested
- Radial extracorporeal shock wave therapy and conventional physical therapy
- Keywords
- stroke, spasticity, neurological rehabilitation, radial extracorporeal shock wave therapy, gait analysis system
- Medical subject headings
- Ischemic Stroke, Hemorrhagic Stroke, Muscle Spasticity, Gait Disorders, Neurologic, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial extracorporeal shock wave therapy and conventional physical therapyOther
The conventional physical therapy program will consist of verticalization strategies, range of motion exercises, muscle stretching and strengthening exercises, stance and balance training, core stability exercises, gait training, functional training, cryotherapy or local heat for 1h/day, 5 days/week for 2 weeks.
Regarding the rESWT delivery, 2000 shots will be applied on the triceps surae myotendinous junction with a frequency of 10 Hz and an energy density of 60 mJ, 7 min/session, 1 session/week for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Study group | The patients considered eligible will form the study group and will start the conventional physical therapy program and radial extracorporeal shock wave therapy delivery (rESWT). Receives: Other: Radial extracorporeal shock wave therapy and conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spasticity grade change
Modified Ashworth Scale (MAS); ranges from 0 (no increase in muscle tone) to 5 (rigid limb in flexion or extension). The lower the score, the lower spasticity grade, thus a better outcome.
Measured: Change from baseline Modified Ashworth Scale at 14 days
Secondary outcomes (4)
Ankle passive range of motion change
Passive range of motion (PROM); flexion 0-30 degrees, extension 0-50 degrees, pronation 0-30 degrees, supination 0-60 degrees. Higher scores define augmented, better range of motion.
Measured: Change from baseline Passive Range of Motion at 14 days
Pain intensity change
Visual Analogue Scale (VAS); the greater the value on the 0.1 meters line, the greater the pain intensity starting from 0 (no pain at all) to 10 (the highest pain intensity ever experienced).
Measured: Change from baseline Visual Analogue Scale at 14 days
Step length change
Step length (meters); ranges from 0-0.5 meters, the higher the step length leads to better outcome.
Measured: Change from baseline step length at 14 days
Knee flexion-extension change
Knee flexion-extension; Maximum and minimum angle value in the sagittal plane of knee, from 0 degrees in full extension to 140-150 degrees in maximum flexion.
Measured: Change from baseline knee flexion-extension 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 posted25 Jan 2022
- Study start1 Mar 2021
- Primary completion1 Jun 2022
- Study completion1 Aug 2022
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 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, Elias University Emergency Hospital, Bucharest, Romania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206240
- Sponsor's protocol ID
- 2090
- Status last verified
- Feb 2023
- First submitted
- 24 Dec 2021
- Last updated
- 16 Feb 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 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Extracorporeal Shock Wave Therapy and Assessment Strategy Through a Novel Gait Analysis Tool for Post-stroke Spasticity During COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT05206240
- Acronym / sponsor ID
- 2090
- Conditions
- Stroke, Ischemic, Stroke Hemorrhagic, Spasticity, Muscle, Spastic Gait
- Keywords
- stroke, spasticity, neurological rehabilitation, radial extracorporeal shock wave therapy, gait analysis system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Carol Davila University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 25 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.
The aim of this study is to objectively evaluate the effectiveness of radial extracorporeal shock wave therapy (rESWT) and conventional physical therapy program on the gait pattern through a new gait analysis system which encompasses spatiotemporal and kinematic parameters and to correlate the findings with the clinical evaluation.
Detailed description
The aim of this observational study was to objectively evaluate the effects of radial extracorporeal shock wave therapy and conventional physical therapy program on the gait pattern, spatiotemporal variables (step length, step cycle time, stance foot flexion-extension, foot stance pronation-supination, and foot swing flexion-extension), and kinematic parameters (trunk flexion-extension, trunk lateral flexion, hip flexion-extension, knee flexion-extension, ankle flexion-extension) through a new gait analysis system and correlate the findings with clinical outcomes such as Modified Ashworth scale (MAS), passive range of motion (PROM), Clonus score, Visual Analogue Scale (VAS), Tinetti Assessment Tool, Functional Ambulation Categories (FAC).
The gait pattern of post-stroke patients before and after rESWT delivery and conventional rehabilitation program will be assessed clinically and also through an instrumented treadmill (Walker View) in terms of spatiotemporal and kinematic gait parameters.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Radial extracorporeal shock wave therapy and conventional physical therapyThe patients considered eligible will form the study group and will start the conventional physical therapy program and radial extracorporeal shock wave therapy delivery (rESWT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients from the Physical and Rehabilitation Medicine Department stating the eligibility criteria
Key inclusion criteria (6 listed)
- suffered from a hemorrhagic or ischemic stroke and they were in the subacute or chronic phase;
- had no history of previous stroke;
- had 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 and walk unassisted for at least 30 seconds;
Key exclusion criteria (6 listed)
- other neurological, musculoskeletal, orthopaedic, or cardiovascular conditions; -- severe cognitive impairment, severe aphasia or inability to understand or execute instructions;
- changes in antispastic medication and dose or changes in the analgesic medication;
- myopathy;
- severe spasticity grade;
- visual field disorders 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 therapy and conventional physical therapyThe conventional physical therapy program will consist of verticalization strategies, range of motion exercises, muscle stretching and strengthening exercises, stance and balance training, core stability exercises, gait training, functional training, cryotherapy or local heat for 1h/day, 5 days/week for 2 weeks. Regarding the rESWT delivery, 2000 shots will be applied on the triceps surae myotendinous junction with a frequency of 10 Hz and an energy density of 60 mJ, 7 min/session, 1 session/week for 2 weeks. | Other | Study group |
Primary outcome
Spasticity grade change
Time frame: Change from baseline Modified Ashworth Scale at 14 days
Modified Ashworth Scale (MAS); ranges from 0 (no increase in muscle tone) to 5 (rigid limb in flexion or extension). The lower the score, the lower spasticity grade, thus a better outcome.
4 secondary outcomes
Ankle passive 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
Step length change
Time frame: Change from baseline step length at 14 days
Knee flexion-extension change
Time frame: Change from baseline knee flexion-extension 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 16 Feb 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.
Mihai Berteanu study director
Elias University Emergency Hospital, Bucharest, Romania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 6 inclusion and 6 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 16 Feb 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 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. 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 16 Feb 2023.