NCT00989430

Brief Summary

The purpose of this research study with a randomized controlled design is to examine the effects of prism adaptation treatment on two visual-spatial recovery components. After a stroke, an "internal GPS", locating where objects or people lie in a particular area of space, may be impaired. Alternately, a stroke may impair precise visual-spatial hand and body aiming movements. The research team wishes to discover whether prism adaptation treatment (two weeks of daily 20-min sessions of goal-directed movement with prism goggles) affects visual-spatial where or aiming errors selectively after stroke. This research represents one of the first attempts to apply what we know about the brain from neuroscience research, to modern clinical rehabilitation practices.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 2, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 5, 2009

Completed
3 years until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

February 17, 2021

Status Verified

February 1, 2021

Enrollment Period

9 years

First QC Date

October 2, 2009

Last Update Submit

February 16, 2021

Conditions

Spatial NeglectDeficits in Attention Motor Control and Perception

Keywords

strokeCVAcerebrovascular accidentrehabilitation

Outcome Measures

Primary Outcomes (1)

  • Kessler Foundation Neglect Assessment Process

    a performance based and behavioral measure for spatial neglect that utilizes and standardizes the administration of the Catherine Bergego Scale (CBS)

    6 months

Secondary Outcomes (2)

  • Behavior Inattention Test

    2 weeks

  • Barthel Index

    2 weeks

Study Arms (2)

Prism Adaptation Treatment

EXPERIMENTAL

Two weeks of prism adaptation treatment followed by 4 weekly assessments and long-term follow-ups at the 3rd and 6th months.

Behavioral: Prism Adaptation Treatment

Control: Standard Rehabilitation Care

NO INTERVENTION

Participants will continue with their standard inpatient rehabilitation care. They will be assessed with cognitive and functional scales for tracking their recovery.

Interventions

Prism Adaptation TreatmentBEHAVIORAL

Wearing prism goggles and performing visuomotor tasks during therapy sessions.

Prism Adaptation Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The subject is 18 to 100 years of age, inclusive.
  • The subject has had a stroke on the right side of the brain.
  • The subject is able to give Informed consent.
  • The subject has a spatial neglect (if known).
  • The subject is able and willing to comply with the study protocol, including availability for all scheduled clinic visits.

You may not qualify if:

  • The subject has or had a serious brain condition other than stroke.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kessler Institute for Rehabilitation

West Orange, New Jersey, 07052, United States

Location

Related Publications (3)

  • Longley V, Hazelton C, Heal C, Pollock A, Woodward-Nutt K, Mitchell C, Pobric G, Vail A, Bowen A. Non-pharmacological interventions for spatial neglect or inattention following stroke and other non-progressive brain injury. Cochrane Database Syst Rev. 2021 Jul 1;7(7):CD003586. doi: 10.1002/14651858.CD003586.pub4.

    PMID: 34196963DERIVED

  • Boukrina O, Chen P, Budinoska T, Barrett AM. Exploratory examination of lexical and neuroanatomic correlates of neglect dyslexia. Neuropsychology. 2020 May;34(4):404-419. doi: 10.1037/neu0000619. Epub 2020 Jan 30.

    PMID: 31999167DERIVED

  • Caulfield MD, Chen P, Barry MM, Barrett AM. Which perseverative behaviors are symptoms of spatial neglect? Brain Cogn. 2017 Apr;113:93-101. doi: 10.1016/j.bandc.2016.11.002. Epub 2017 Feb 3.

    PMID: 28167411DERIVED

Related Links

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • A. M. Barrett, MD

    Kessler Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Stroke Rehabilitation Research

Study Record Dates

First Submitted

October 2, 2009

First Posted

October 5, 2009

Study Start

October 1, 2012

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

February 17, 2021

Record last verified: 2021-02

Locations

US(1)