Clinical trial NCT02824900: Vibration Stimuli in Stroke Patients With Contraversive Pusher Syndrome
Official title: Vibration Stimuli in Stroke Patients With Contraversive Pusher Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stroke
Keywords: Vibration Stimuli
Contraversive Pusher Syndrome
Lead sponsor: Loewenstein Hospital
Sponsor class: OTHER
Collaborators: name: Tel Aviv University
First posted: 2016-07-07
Enrollment: 0
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Having previous neurological and orthopedic disability.
* Having pacemakers.

Primary outcomes:
measure: Change in Clinical Scale for Contraversive Pushing
timeFrame: 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:
measure: Change in Lateropulsion Scale
timeFrame: 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)
measure: Change in Postural Assessment Scale for Stroke Patients
timeFrame: 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)
measure: Change in Anterior and lateral functional reach test
timeFrame: 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)
measure: Change in Posturography
timeFrame: 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)
measure: Change in Neglect - Behavioral Inattention Test
timeFrame: 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)
measure: Change in Neglect - Mesulam Cancellation Test
timeFrame: 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)
measure: Change in Neglect - Line Bisection
timeFrame: 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)
measure: Change in Neglect - Test Dynamic Starry Night
timeFrame: 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)
measure: Change in Subjective Straight Ahead
timeFrame: 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)
measure: Change in Sensory evaluation
timeFrame: 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)
Other outcomes:
Locations:
Study officials:
affiliation: Loewenstein Hospital
name: Sivi Frenkel-Toledo, PhD
role: STUDY_DIRECTOR
References: