NCT02824900

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2016

Typical duration for not_applicable stroke

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

October 17, 2017

Status Verified

October 1, 2017

Enrollment Period

2 years

First QC Date

June 29, 2016

Last Update Submit

October 15, 2017

Conditions

Stroke

Keywords

Vibration StimuliContraversive Pusher Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Change in Lateropulsion Scale

    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

    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

    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

    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

    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)

  • +5 more secondary outcomes

Study Arms (2)

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.

Device: Vibration stimuli to neck musclesBehavioral: 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.

Device: Vibration stimuli to handBehavioral: conventional physiotherapy

Interventions

Vibration stimuli to neck musclesDEVICE
Vibration stimuli to neck
Vibration stimuli to handDEVICE
Vibration stimuli to hand
conventional physiotherapyBEHAVIORAL
Vibration stimuli to handVibration stimuli to neck

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Sivi Frenkel-Toledo, PhD

    Loewenstein Hospital

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
head, Department of neurologic rehabilitation, Loewenstein rehabilitation hospital, Raanana,Israel

Study Record Dates

First Submitted

June 29, 2016

First Posted

July 7, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

October 17, 2017

Record last verified: 2017-10