StrokeNCT03419793
Effect of Segmental Muscle Vibration on Upper Extremity Functional Ability Post Stroke
A study testing segmental vibration device and physical therapy exercises in people with Stroke, run by University of Rome Tor Vergata.
Trial summary
Background and objective: Upper extremity functional impairments are common consequences post stroke. The aim of this study was to investigate the influence of Segmental muscle vibration (SMV) application along with supervised physical therapy (SPT) on improving activities of daily living (ADL) and motor recovery on… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- segmental vibration device and physical therapy exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jan 2018
- 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).
About this study
Background and objective: Upper extremity functional impairments are common consequences post stroke. The aim of this study was to investigate the influence of Segmental muscle vibration (SMV) application along with supervised physical therapy (SPT) on improving activities of daily living (ADL) and motor recovery on the hemiparetic upper extremity in patients with stroke.
Methods: A sample of 37 patients post stroke (29 males) was randomly assigned to either supervised physical therapy (SPT) control group (n=18) or supervised physical therapy and segmental muscle vibration (SPT-SMV) experimental group (n=19). All patients received 3 sessions per week of SPT for 8 weeks. The SPT-SMV experimental group received SMV at the end of each SPT session. Outcome measures used were Barthel Index (BI), Modified Ashworth Scale (MAS), Manual Muscle Testing (MMT), and goniometry for Range of Motion (ROM) assessment.
- Conditions
- Stroke
- Being tested
- segmental vibration device, physical therapy exercises
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
segmental vibration deviceDevice
Also called physical therapy intervention
segmental vibration device
physical therapy exercisesOther
Also called manual resistance exercise
| Study group | Role | What they receive |
|---|---|---|
| physical therapy intervention and segmental muscle vibration | Experimental | physiotherapy intervention and segmental muscle vibration device Receives: Device: segmental vibration device; Other: physical therapy exercises |
| physical therapy intervention | Sham comparator | physical therapy intervention alone Receives: Other: physical therapy exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Secondary outcomes (3)
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 Functional level at 8 weeks
Manual Muscle Testing (MMT)
Muscle strength assessed by using manual muscle testing (MMT) . The six- point Medical Research Council (MRC) Scale is the most often used system, with the procedures detecting the magnitude of strength by grading muscle strength from 0 to 5. In which a score of 0 was no contraction, 1 was a flicker of contraction, 2 was active movement with gravity eliminated, 3 was active movement against gravity, 4 was active movement against gravity and resistance and 5 was normal power
Measured: Change from Baseline Muscle power at 8 weeks
Modified Ashworth Scale (MAS)
The scale is used to assign a subjective rating of the amount of resistance or tone perceived by the examiner as a limb is moved through its full range of motion. The original Ashworth scale consisted of 5 grades from 0 - 4. in which score of 0 was no increase in muscle tone, 1 was Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension, 1+ was slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM, 2 was more marked increase in muscle tone through most of the ROM, but affected part(s) easily moved, 3 was considerable increase in muscle tone, passive movement difficult and 4 was affected part(s) rigid in flexion or extension
Measured: Change from Baseline muscle tone 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 posted5 Feb 2018
- Study startJul 2016
- Primary completionSep 2016
- Study completionJan 2018
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.
- 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
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Annino, University of Rome Tor Vergata
- Investigators
- Giuseppe Annino, PhD, Study director, department of medicine systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419793
- Sponsor's protocol ID
- 212/17
- Status last verified
- Jan 2018
- First submitted
- 18 Jan 2018
- Last updated
- 5 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Segmental Muscle Vibration on Upper Extremity Functional Ability Post Stroke
- ClinicalTrials.gov ID
- NCT03419793
- Acronym / sponsor ID
- 212/17
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 5 Feb 2018 (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 objective: Upper extremity functional impairments are common consequences post stroke. The aim of this study was to investigate the influence of Segmental muscle vibration (SMV) application along with supervised physical therapy (SPT) on improving activities of daily living (ADL) and motor recovery on the hemiparetic upper extremity in patients with stroke.
Methods: A sample of 37 patients post stroke (29 males) was randomly assigned to either supervised physical therapy (SPT) control group (n=18) or supervised physical therapy and segmental muscle vibration (SPT-SMV) experimental group (n=19). All patients received 3 sessions per week of SPT for 8 weeks. The SPT-SMV experimental group received SMV at the end of each SPT session. Outcome measures used were Barthel Index (BI), Modified Ashworth Scale (MAS), Manual Muscle Testing (MMT), and goniometry for Range of Motion (ROM) assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| physical therapy intervention and segmental muscle vibration | Experimental | Device: segmental vibration device, Other: physical therapy exercisesphysiotherapy intervention and segmental muscle vibration device |
| physical therapy intervention | Sham comparator | Other: physical therapy exercisesphysical therapy intervention alone |
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 |
|---|---|---|
| segmental vibration deviceAlso: physical therapy interventionsegmental vibration device | Device | physical therapy intervention and segmental muscle vibration |
| physical therapy exercisesAlso: manual resistance exercise | Other | physical therapy intervention, physical therapy intervention and segmental muscle vibration |
Primary outcome
goniometry
Time frame: Change from Baseline Range of Motion at 8 weeks
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.
3 secondary outcomes
Barthel Index (BI)
Time frame: Change from Baseline Functional level at 8 weeks
Manual Muscle Testing (MMT)
Time frame: Change from Baseline Muscle power at 8 weeks
Modified Ashworth Scale (MAS)
Time frame: Change from Baseline muscle tone at 8 weeks
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 5 Feb 2018.
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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
department of medicine systems
Questions about this trial
What is this clinical trial studying?
A study testing segmental vibration device and physical therapy exercises in people with Stroke, run by University of Rome Tor Vergata.
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: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
goniometry (time frame: Change from Baseline Range of Motion at 8 weeks). 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 5 Feb 2018.