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Vibration Stimuli in Stroke Patients With Contraversive Pusher Syndrome

NCT ID: NCT02824900

Last Updated: 2017-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-07-31

Brief Summary

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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

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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

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Stroke

Keywords

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Vibration Stimuli Contraversive Pusher Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Vibration stimuli to neck

Vibration stimuli to contralesional neck muscles, 5 days per week, for 2 weeks, 20 minutes per day + structured (conventional exercises) daily physiotherapy \~ 45 minutes.

Group Type EXPERIMENTAL

Vibration stimuli to neck muscles

Intervention Type DEVICE

conventional physiotherapy

Intervention Type BEHAVIORAL

Vibration stimuli to hand

Vibration stimuli to contralesional hand, 5 days per week, for 2 weeks, 20 minutes per day + structured (conventional exercises) daily physiotherapy \~ 45 minutes.

Group Type ACTIVE_COMPARATOR

Vibration stimuli to hand

Intervention Type DEVICE

conventional physiotherapy

Intervention Type BEHAVIORAL

Interventions

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Vibration stimuli to neck muscles

Intervention Type DEVICE

Vibration stimuli to hand

Intervention Type DEVICE

conventional physiotherapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel Aviv University

OTHER

Sponsor Role collaborator

Nachum Soroker, MD

OTHER

Sponsor Role lead

Responsible Party

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Nachum Soroker, MD

head, Department of neurologic rehabilitation, Loewenstein rehabilitation hospital, Raanana,Israel

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sivi Frenkel-Toledo, PhD

Role: STUDY_DIRECTOR

Loewenstein Hospital

Other Identifiers

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loe162315CTIL

Identifier Type: -

Identifier Source: org_study_id