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Vibration Stimuli in Stroke Patients With Contraversive Pusher Syndrome

Not Applicable
Withdrawn
Conditions
Stroke
Interventions
Device: Vibration stimuli to neck muscles
Device: Vibration stimuli to hand
Behavioral: conventional physiotherapy
Registration Number
NCT02824900
Lead Sponsor
Nachum Soroker, MD
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.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Vibration stimuli to neckconventional 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 neckVibration stimuli to neck musclesVibration 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 handVibration stimuli to handVibration stimuli to contralesional hand, 5 days per week, for 2 weeks, 20 minutes per day + structured (conventional exercises) daily physiotherapy \~ 45 minutes.
Vibration stimuli to handconventional physiotherapyVibration stimuli to contralesional hand, 5 days per week, for 2 weeks, 20 minutes per day + structured (conventional exercises) daily physiotherapy \~ 45 minutes.
Primary Outcome Measures
NameTimeMethod
Change in Clinical Scale for Contraversive PushingBefore 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.

Secondary Outcome Measures
NameTimeMethod
Change in Anterior and lateral functional reach testBefore 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)

Assesses equilibrium during sitting by measuring the distance of the anterior and lateral reaching with the upper limb.

Change in PosturographyBefore 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)

Force Platform that calculates the amount of weight bearing on right and left side during sitting.

Change in Neglect - Mesulam Cancellation TestBefore 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)

Cancellation of forms. Assesses the amount of attention to the left side.

Change in Neglect - Line BisectionBefore 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)

Assesses the amount of deviation from the center of different lines decided by the subject. Assesses the amount of attention to the left side.

Change in Lateropulsion ScaleBefore 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: 0-17. Score of zero indicated no pushing. Assesses pushing during supine, sitting, standing, transfers and walking.

Change in Postural Assessment Scale for Stroke PatientsBefore 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: 0-36. Score of 36 indicates performance without help. Assesses maintenance and change of posture.

Change in Neglect - Behavioral Inattention TestBefore 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: 0-146. Cutoff score: 129. Assesses the amount of attention to the left side during different task (such as: star and lines cancellation).

Change in Neglect - Test Dynamic Starry NightBefore 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)

Computerized task. Measures the reaction time and the number of neglected goals.

Change in Subjective Straight AheadBefore 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)

Assesses the subjective alignment of the body.

Change in Sensory evaluationBefore 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)

Assesses superficial sensation in foot and proprioception in toes.

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