StrokeNCT02824900
Vibration Stimuli in Stroke Patients With Contraversive Pusher Syndrome
A study testing Vibration stimuli to neck muscles, Vibration stimuli to hand and conventional physiotherapy in people with Stroke, run by Nachum Soroker, MD.
Trial summary
The purpose of this study is to investigate the effects of vibration stimuli to contra lateral neck muscles on Contraversive Pusher Syndrome, function and neglect in stroke patients. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Vibration stimuli to neck muscles, Vibration stimuli to hand and conventional physiotherapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jul 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First stroke
- Age 25-75 years
- Able to understand research instructions
- Stable clinical/metabolic state.
- Having Contraversive Pushing Syndrome, based on Clinical Scale for Contraversive Pushing.
Who cannot join
- Having previous neurological and orthopedic disability.
- Having pacemakers.
About this study
The purpose of this study is to investigate the effects of vibration stimuli to contra lateral neck muscles on Contraversive Pusher Syndrome, function and neglect in stroke patients.
Read the detailed description
12 post-stroke subjects will be recruited from neurological rehabilitation department at Loewenstein rehabilitation hospital, Raanana, Israel. The patients will be randomly assigned to one of two groups: 1) Experimental group. 2) Control group. The 2 weeks intervention (10 sessions) in each group will include vibration stimuli (frequency of 1 Hz and amplitude of 20 mm) for 20 minutes and structured standard physiotherapy for 45 minutes. The vibration stimuli in the experimental group will be done to the contralesional neck muscles, whereas the vibration stimuli in the control group will be done in the contralesional hand. Different assessments will be done before the intervention, after the first day of intervention, after two weeks of intervention and one months post-intervention. The tests will include: Clinical Scale for Contraversive Pushing, Lateropulsion Scale, Subjective Straight Ahead, Postural Assesment Scale for Stroke Patients, Anterior and Lateral Functional Reach Test, Posturography, Behavioral Inattention Test, Mesulam Cancellation Test, Line Bisection Test, Dynamic Starry Night and sensation.
Differences between groups will be calculated using t-tests or Mann-Whitney, depending on distribution of normality with corrections for multiple comparisons. Smallest Real Difference (SRD) will be calculated for detecting the minimal detectable change.
- Conditions
- Stroke
- Being tested
- Vibration stimuli to neck muscles, Vibration stimuli to hand, conventional physiotherapy
- Keywords
- Vibration Stimuli, Contraversive Pusher Syndrome
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibration stimuli to neck musclesDevice
Vibration stimuli to handDevice
conventional physiotherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Vibration stimuli to neck | Experimental | Vibration stimuli to contralesional neck muscles, 5 days per week, for 2 weeks, 20 minutes per day + structured (conventional exercises) daily physiotherapy ~ 45 minutes. Receives: Device: Vibration stimuli to neck muscles; Behavioral: conventional physiotherapy |
| Vibration stimuli to hand | Active comparator | Vibration stimuli to contralesional hand, 5 days per week, for 2 weeks, 20 minutes per day + structured (conventional exercises) daily physiotherapy ~ 45 minutes. Receives: Device: Vibration stimuli to hand; Behavioral: conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinical Scale for Contraversive Pushing
Score range: 0-6. Score of zero indicates no pushing. Assesses pushing during spontaneous body posture, abduction and extension of the nonparetic extremities and resistance to passive correction of tilted posture.
Measured: Before the intervention, after the first day of intervention, after 2 weeks (end of intervention), and one month after the end of the intervention (follow up)
Secondary outcomes (10)
Change in Lateropulsion Scale
Score range: 0-17. Score of zero indicated no pushing. Assesses pushing during supine, sitting, standing, transfers and walking.
Measured: Before the intervention, after the first day of intervention, after 2 weeks (end of intervention), and one month after the end of the intervention (follow up)
Change in Postural Assessment Scale for Stroke Patients
Score range: 0-36. Score of 36 indicates performance without help. Assesses maintenance and change of posture.
Measured: Before the intervention, after the first day of intervention, after 2 weeks (end of intervention), and one month after the end of the intervention (follow up)
Change in Anterior and lateral functional reach test
Assesses equilibrium during sitting by measuring the distance of the anterior and lateral reaching with the upper limb.
Measured: Before the intervention, after the first day of intervention, after 2 weeks (end of intervention), and one month after the end of the intervention (follow up)
Change in Posturography
Force Platform that calculates the amount of weight bearing on right and left side during sitting.
Measured: Before the intervention, after the first day of intervention, after 2 weeks (end of intervention), and one month after the end of the intervention (follow up)
Change in Neglect - Behavioral Inattention Test
Score range: 0-146. Cutoff score: 129. Assesses the amount of attention to the left side during different task (such as: star and lines cancellation).
Measured: Before the intervention, after the first day of intervention, after 2 weeks (end of intervention), and one month after the end of the intervention (follow up)
Change in Neglect - Mesulam Cancellation Test
Cancellation of forms. Assesses the amount of attention to the left side.
Measured: Before the intervention, after the first day of intervention, after 2 weeks (end of intervention), and one month after the end of the intervention (follow up)
Change in Neglect - Line Bisection
Assesses the amount of deviation from the center of different lines decided by the subject. Assesses the amount of attention to the left side.
Measured: Before the intervention, after the first day of intervention, after 2 weeks (end of intervention), and one month after the end of the intervention (follow up)
Change in Neglect - Test Dynamic Starry Night
Computerized task. Measures the reaction time and the number of neglected goals.
Measured: Before the intervention, after the first day of intervention, after 2 weeks (end of intervention), and one month after the end of the intervention (follow up)
Change in Subjective Straight Ahead
Assesses the subjective alignment of the body.
Measured: Before the intervention, after the first day of intervention, after 2 weeks (end of intervention), and one month after the end of the intervention (follow up)
Change in Sensory evaluation
Assesses superficial sensation in foot and proprioception in toes.
Measured: Before the intervention, after the first day of intervention, after 2 weeks (end of intervention), and one month after the end of the intervention (follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (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.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nachum Soroker, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Tel Aviv University
- Responsible party
- Sponsor-investigator, Nachum Soroker, MD, Loewenstein Hospital
- Investigators
- Sivi Frenkel-Toledo, PhD, Study director, Loewenstein Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824900
- Sponsor's protocol ID
- loe162315CTIL
- Status last verified
- Oct 2017
- First submitted
- 29 Jun 2016
- Last updated
- 17 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vibration Stimuli in Stroke Patients With Contraversive Pusher Syndrome
- ClinicalTrials.gov ID
- NCT02824900
- Acronym / sponsor ID
- loe162315CTIL
- Conditions
- Stroke
- Keywords
- Vibration Stimuli, Contraversive Pusher Syndrome
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nachum Soroker, MDUniversity, hospital or other
- Collaborators
- Tel Aviv University
- Study start
- Jul 2016
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 7 Jul 2016 (estimated)
- 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 purpose of this study is to investigate the effects of vibration stimuli to contra lateral neck muscles on Contraversive Pusher Syndrome, function and neglect in stroke patients.
Detailed description
12 post-stroke subjects will be recruited from neurological rehabilitation department at Loewenstein rehabilitation hospital, Raanana, Israel. The patients will be randomly assigned to one of two groups: 1) Experimental group. 2) Control group. The 2 weeks intervention (10 sessions) in each group will include vibration stimuli (frequency of 1 Hz and amplitude of 20 mm) for 20 minutes and structured standard physiotherapy for 45 minutes. The vibration stimuli in the experimental group will be done to the contralesional neck muscles, whereas the vibration stimuli in the control group will be done in the contralesional hand. Different assessments will be done before the intervention, after the first day of intervention, after two weeks of intervention and one months post-intervention. The tests will include: Clinical Scale for Contraversive Pushing, Lateropulsion Scale, Subjective Straight Ahead, Postural Assesment Scale for Stroke Patients, Anterior and Lateral Functional Reach Test, Posturography, Behavioral Inattention Test, Mesulam Cancellation Test, Line Bisection Test, Dynamic Starry Night and sensation.
Differences between groups will be calculated using t-tests or Mann-Whitney, depending on distribution of normality with corrections for multiple comparisons. Smallest Real Difference (SRD) will be calculated for detecting the minimal detectable change.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vibration stimuli to neck | Experimental | Device: Vibration stimuli to neck muscles, Behavioral: conventional physiotherapyVibration stimuli to contralesional neck muscles, 5 days per week, for 2 weeks, 20 minutes per day + structured (conventional exercises) daily physiotherapy ~ 45 minutes. |
| Vibration stimuli to hand | Active comparator | Device: Vibration stimuli to hand, Behavioral: conventional physiotherapyVibration stimuli to contralesional hand, 5 days per week, for 2 weeks, 20 minutes per day + structured (conventional exercises) daily physiotherapy ~ 45 minutes. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- First stroke
- Age 25-75 years
- Able to understand research instructions
- Stable clinical/metabolic state.
- Having Contraversive Pushing Syndrome, based on Clinical Scale for Contraversive Pushing.
Key exclusion criteria (2 listed)
- Having previous neurological and orthopedic disability.
- Having pacemakers.
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 |
|---|---|---|
| Vibration stimuli to neck muscles | Device | Vibration stimuli to neck |
| Vibration stimuli to hand | Device | Vibration stimuli to hand |
| conventional physiotherapy | Behavioural | Vibration stimuli to hand, Vibration stimuli to neck |
Primary outcome
Change in Clinical Scale for Contraversive Pushing
Time frame: Before the intervention, after the first day of intervention, after 2 weeks (end of intervention), and one month after the end of the intervention (follow up)
Score range: 0-6. Score of zero indicates no pushing. Assesses pushing during spontaneous body posture, abduction and extension of the nonparetic extremities and resistance to passive correction of tilted posture.
10 secondary outcomes
Change in Lateropulsion Scale
Time frame: Before the intervention, after the first day of intervention, after 2 weeks (end of intervention), and one month after the end of the intervention (follow up)
Change in Postural Assessment Scale for Stroke Patients
Time frame: Before the intervention, after the first day of intervention, after 2 weeks (end of intervention), and one month after the end of the intervention (follow up)
Change in Anterior and lateral functional reach test
Time frame: Before the intervention, after the first day of intervention, after 2 weeks (end of intervention), and one month after the end of the intervention (follow up)
Change in Posturography
Time frame: Before the intervention, after the first day of intervention, after 2 weeks (end of intervention), and one month after the end of the intervention (follow up)
Change in Neglect - Behavioral Inattention Test
Time frame: Before the intervention, after the first day of intervention, after 2 weeks (end of intervention), and one month after the end of the intervention (follow up)
Change in Neglect - Mesulam Cancellation Test
Time frame: Before the intervention, after the first day of intervention, after 2 weeks (end of intervention), and one month after the end of the intervention (follow up)
Change in Neglect - Line Bisection
Time frame: Before the intervention, after the first day of intervention, after 2 weeks (end of intervention), and one month after the end of the intervention (follow up)
Change in Neglect - Test Dynamic Starry Night
Time frame: Before the intervention, after the first day of intervention, after 2 weeks (end of intervention), and one month after the end of the intervention (follow up)
Change in Subjective Straight Ahead
Time frame: Before the intervention, after the first day of intervention, after 2 weeks (end of intervention), and one month after the end of the intervention (follow up)
Change in Sensory evaluation
Time frame: Before the intervention, after the first day of intervention, after 2 weeks (end of intervention), and one month after the end of the intervention (follow up)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2017.
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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.
Sivi Frenkel-Toledo, PhD study director
Loewenstein Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Vibration stimuli to neck muscles, Vibration stimuli to hand and conventional physiotherapy in people with Stroke, run by Nachum Soroker, MD.
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 5 inclusion and 2 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: withdrawn, as of the sponsor's last update on 17 Oct 2017. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Clinical Scale for Contraversive Pushing (time frame: Before the intervention, after the first day of intervention, after 2 weeks (end of intervention), and one month after the end of the intervention (follow up)). 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 17 Oct 2017.