Vibration Stimuli in Stroke Patients With Contraversive Pusher Syndrome

Stroke Clinical Trial

Official title:

Vibration Stimuli in Stroke Patients With Contraversive Pusher Syndrome

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02824900
• Other study ID #: loe162315CTIL
• Status: Withdrawn
• Phase: N/A
• First received: June 29, 2016
• Last updated: October 15, 2017
• Start date: July 2016
• Est. completion date: July 2018

Study information

• Verified date: October 2017
• Source: Loewenstein Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Vibration stimuli to neck muscles

• Vibration stimuli to hand

Behavioral:
• conventional physiotherapy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Nachum Soroker, MD	Tel Aviv University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	Change in Lateropulsion Scale	Score range: 0-17. Score of zero indicated no pushing. Assesses pushing during supine, sitting, standing, transfers and walking.	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	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.	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	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.	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	Change in Posturography	Force Platform that calculates the amount of weight bearing on right and left side during sitting.	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	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).	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	Change in Neglect - Mesulam Cancellation Test	Cancellation of forms. Assesses the amount of attention to the left side.	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	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.	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	Change in Neglect - Test Dynamic Starry Night	Computerized task. Measures the reaction time and the number of neglected goals.	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	Change in Subjective Straight Ahead	Assesses the subjective alignment of the body.	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	Change in Sensory evaluation	Assesses superficial sensation in foot and proprioception in toes.	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)