StrokeNCT04700553
Localized Muscle Vibration Post Stroke
A study testing Localized muscle vibration and Conventional physiotherapy intervention in people with Stroke, run by Giuseppe Annino at 1 site in Italy.
Trial summary
Background and objectives: Lower extremity functional impairments are common consequences of stroke. Thus, continuous examination of effective treatment interventions for lower extremity functions after stroke is a necessity. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- Localized muscle vibration and Conventional physiotherapy intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2023to 31 Aug 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Confirmed diagnosis of stroke
Who cannot join
- If they had any serious orthopedic injury/disease, cardiopulmonary problems or suffered from a neurological disease (other than stroke).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Localized Muscle Vibration on Lower Extremity Functional Ability in Patients With Stroke: A Randomized Controlled Trial
Background and objectives: Lower extremity functional impairments are common consequences of stroke. Thus, continuous examination of effective treatment interventions for lower extremity functions after stroke is a necessity. Localized muscle vibration (LMV) is one of the treatment interventions that incorporate sensory stimulation to improve motor cortical excitability. This study aimed to investigate the influences of 10-minutes lower extremity LMV application along with conventional physical therapy (CPT) on activities of daily living (ADL) and motor recovery on the hemiparetic lower extremity post-stroke.
Methods: A sample of 37 patients with stroke (8 females) was randomly allocated to either conventional physical therapy (CPT) control group (n=18) or conventional physical therapy and localized muscle vibration (CPT+LMV) experimental group (n=19). All patients received 3 sessions per week of CPT for 8 weeks. The CPT+LMV experimental group received 10-minute LMV at the end of each CPT session. The outcome measures used were the Barthel Index (BI), Berg Balance Scale (BBS), and goniometry for Range of Motion (ROM) assessment.
Read the detailed description
All patients in both experimental and control groups received CPT protocol consisted of 30 minutes of manual resistance exercise (3 sets/10 repetitions each for knee extensors and flexors) and 30 minutes of treadmill training, short breaks (1-5 minutes) were allowed, depending on the patient tolerance. The training was conducted for 3 days per week for 8 weeks. The patients in CPT+LMV experimental group received localized muscle vibration at the end of each CPT session. The LMV was applied for 10 minutes perpendicularly along quadriceps muscle fibers. The frequency set at 30 Hz, amplitude of 2 mm.
- Conditions
- Stroke
- Being tested
- Localized muscle vibration, Conventional physiotherapy intervention
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Localized muscle vibrationDevice
Also called manual resistance exercise, treadmill training
All patients in both experimental and control groups received CPT protocol consisted of 30 minutes of manual resistance exercise (3 sets/10 repetitions each for knee extensors and flexors) and 30 minutes of treadmill training, short breaks (1-5 minutes) were allowed, depending on the patient tolerance. The training was conducted for 3 days per week for 8 weeks. The patients in CPT+LMV experimental group received localized muscle vibration at the end of each CPT session. The LMV was applied for 5 minutes perpendicularly along quadriceps muscle fibers. The frequency set at 30 Hz, amplitude of 2 mm.
Conventional physiotherapy interventionOther
Also called manual resistance exercise, treadmill training
All patients in both experimental and control groups received CPT protocol consisted of 30 minutes of manual resistance exercise (3 sets/10 repetitions each for knee extensors and flexors) and 30 minutes of treadmill training, short breaks (1-5 minutes) were allowed, depending on the patient tolerance. The training was conducted for 3 days per week for 8 weeks. The patients in CPT+LMV experimental group received localized muscle vibration at the end of each CPT session. The LMV was applied for 5 minutes perpendicularly along quadriceps muscle fibers. The frequency set at 30 Hz, amplitude of 2 mm.
| Study group | Role | What they receive |
|---|---|---|
| Conventional physical therapy intervention plus localized muscle vibration | Experimental | physical therapy intervention plus localized muscle vibration Receives: Device: Localized muscle vibration; Other: Conventional physiotherapy intervention |
| Conventional physical therapy intervention | Sham comparator | physical therapy intervention Receives: Other: Conventional physiotherapy intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barthel Index (BI)
The Barthel Index of Activities of Daily Living (BI). Measure of functional disability. The BI consisting of 10 common activities of daily living (ADL) activities, administered through direct observation. These are assessed for independence/ dependence and scored via an arbitrary weighting system (originally applied to reflect nursing care and social acceptability). Eight of the ten items represent activities related to personal care; the remaining 2 are related to mobility. The index yields a total score out of 100 - the higher the score, the greater the degree of functional independence
Measured: Change from baseline activity of daily livings at 8 weeks
Secondary outcomes (4)
Berg Balance Scale
The BBS provides a quantitative measure of balance. This scale consists of 14 items requiring patients to maintain their positions or complete tasks of varying levels of difficulty. All items are related to everyday life tasks. A score of zero represents an inability of the patient to complete the task and a score of 4 represents the ability of the patient to complete the task independently. The total scores range from 0 - 56. A total score of less than 45 indicates a balance impairment.
Measured: Change from baseline balance at 8 weeks
Goniometry
Range of motion assessed by goniometry; is the measurement of angles, particularly those formed by joints. These angles may be measured in a standing position or in flexion or extension.
Measured: Change from baseline range of motion at 8 weeks
Manual Muscle Testing
The MMT was used to assess muscle strength. The MMT consists of 6 grades. Grade 0 indicates no evidence of contractility (complete paralysis), and 5 indicates movement against gravity plus full resistance.
Measured: Change from baseline range of motion at 8 weeks
Modified Ashworth Scale
The MAS was utilized to measure spasticity. The scale asses the resistance of limb to a rapid passive stretch in 6 scores from 0 to 5. Score 0 indicates normal muscle tone, and 5 indicates rigid limb.
Measured: Change from baseline range of motion at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start1 Jul 2023 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Giuseppe Annino
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Giuseppe Annino, University of Rome Tor Vergata
- Investigators
- Giuseppe Annino, PhD, Study director, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700553
- Sponsor's protocol ID
- 187/20
- Status last verified
- Jun 2023
- First submitted
- 1 Jan 2021
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Annino G, Alashram A, Romagnoli C, Iovane A, Youssef TM, Tancredi V, Padua E, Mercuri NB. Efficacy of localized muscle vibration on lower extremity functional ability in patients with stroke: A randomized controlled trial. J Bodyw Mov Ther. 2025 Jun;42:769-776. doi: 10.1016/j.jbmt.2025.02.004. Epub 2025 Feb 6.
PubMed 40325754
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Localized Muscle Vibration on Lower Extremity Functional Ability in Patients With Stroke: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04700553
- Acronym / sponsor ID
- 187/20
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Giuseppe AnninoUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 8 Jan 2021 (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.
Background and objectives: Lower extremity functional impairments are common consequences of stroke. Thus, continuous examination of effective treatment interventions for lower extremity functions after stroke is a necessity. Localized muscle vibration (LMV) is one of the treatment interventions that incorporate sensory stimulation to improve motor cortical excitability. This study aimed to investigate the influences of 10-minutes lower extremity LMV application along with conventional physical therapy (CPT) on activities of daily living (ADL) and motor recovery on the hemiparetic lower extremity post-stroke.
Methods: A sample of 37 patients with stroke (8 females) was randomly allocated to either conventional physical therapy (CPT) control group (n=18) or conventional physical therapy and localized muscle vibration (CPT+LMV) experimental group (n=19). All patients received 3 sessions per week of CPT for 8 weeks. The CPT+LMV experimental group received 10-minute LMV at the end of each CPT session. The outcome measures used were the Barthel Index (BI), Berg Balance Scale (BBS), and goniometry for Range of Motion (ROM) assessment.
Detailed description
All patients in both experimental and control groups received CPT protocol consisted of 30 minutes of manual resistance exercise (3 sets/10 repetitions each for knee extensors and flexors) and 30 minutes of treadmill training, short breaks (1-5 minutes) were allowed, depending on the patient tolerance. The training was conducted for 3 days per week for 8 weeks. The patients in CPT+LMV experimental group received localized muscle vibration at the end of each CPT session. The LMV was applied for 10 minutes perpendicularly along quadriceps muscle fibers. The frequency set at 30 Hz, amplitude of 2 mm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional physical therapy intervention plus localized muscle vibration | Experimental | Device: Localized muscle vibration, Other: Conventional physiotherapy interventionphysical therapy intervention plus localized muscle vibration |
| Conventional physical therapy intervention | Sham comparator | Other: Conventional physiotherapy interventionphysical therapy intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Confirmed diagnosis of stroke
Key exclusion criteria (1 listed)
- If they had any serious orthopedic injury/disease, cardiopulmonary problems or suffered from a neurological disease (other than stroke).
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 |
|---|---|---|
| Localized muscle vibrationAlso: manual resistance exercise, treadmill trainingAll patients in both experimental and control groups received CPT protocol consisted of 30 minutes of manual resistance exercise (3 sets/10 repetitions each for knee extensors and flexors) and 30 minutes of treadmill training, short breaks (1-5 minutes) were allowed, depending on the patient tolerance. The training was conducted for 3 days per week for 8 weeks. The patients in CPT+LMV experimental group received localized muscle vibration at the end of each CPT session. The LMV was applied for 5 minutes perpendicularly along quadriceps muscle fibers. The frequency set at 30 Hz, amplitude of 2 mm. | Device | Conventional physical therapy intervention plus localized muscle vibration |
| Conventional physiotherapy interventionAlso: manual resistance exercise, treadmill trainingAll patients in both experimental and control groups received CPT protocol consisted of 30 minutes of manual resistance exercise (3 sets/10 repetitions each for knee extensors and flexors) and 30 minutes of treadmill training, short breaks (1-5 minutes) were allowed, depending on the patient tolerance. The training was conducted for 3 days per week for 8 weeks. The patients in CPT+LMV experimental group received localized muscle vibration at the end of each CPT session. The LMV was applied for 5 minutes perpendicularly along quadriceps muscle fibers. The frequency set at 30 Hz, amplitude of 2 mm. | Other | Conventional physical therapy intervention, Conventional physical therapy intervention plus localized muscle vibration |
Primary outcome
Barthel Index (BI)
Time frame: Change from baseline activity of daily livings at 8 weeks
The Barthel Index of Activities of Daily Living (BI). Measure of functional disability. The BI consisting of 10 common activities of daily living (ADL) activities, administered through direct observation. These are assessed for independence/ dependence and scored via an arbitrary weighting system (originally applied to reflect nursing care and social acceptability). Eight of the ten items represent activities related to personal care; the remaining 2 are related to mobility. The index yields a total score out of 100 - the higher the score, the greater the degree of functional independence
4 secondary outcomes
Berg Balance Scale
Time frame: Change from baseline balance at 8 weeks
Goniometry
Time frame: Change from baseline range of motion at 8 weeks
Manual Muscle Testing
Time frame: Change from baseline range of motion at 8 weeks
Modified Ashworth Scale
Time frame: Change from baseline range of motion at 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Derived from this study: PubMed 40325754Annino G, Alashram A, Romagnoli C, Iovane A, Youssef TM, Tancredi V, Padua E, Mercuri NB. Efficacy of localized muscle vibration on lower extremity functional ability in patients with stroke: A randomized controlled trial. J Bodyw Mov Ther. 2025 Jun;42:769-776. doi: 10.1016/j.jbmt.2025.02.004. Epub 2025 Feb 6.
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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.
Giuseppe Annino, PhD study director
University of Rome Tor Vergata
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Localized muscle vibration and Conventional physiotherapy intervention in people with Stroke, run by Giuseppe Annino 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 1 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: status not confirmed, as of the sponsor's last update on 13 Jun 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 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. 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 Anas R Alashram, PhD (00962770376817, anasalashram@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barthel Index (BI) (time frame: Change from baseline activity of daily livings at 8 weeks). 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 NCT04700553, which also lists 1 linked publication.
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 Jun 2023.