Feasibility of Using Prism Adaptation to Treat Spatial Neglect and Motor Function in Stroke

August 16, 2017 updated by: Kessler Foundation

Feasibility of Using Prism Adaptation to Treat Spatial Neglect and Motor Function in Stroke Survivors With Multiple Lesions

This research project is a study designed to address both motor and cognitive changes after stroke. Treatment for SN is elusive however there is support for prism adaptation treatment (PAT). Therapists need to know more about the effects of this treatment and if it is feasible in a group of stroke survivors with multiple lesions because these are the patients they are treating in the clinical setting. Also, it has not been investigated that using PAT to remediate SN will then as a result increase spontaneous UE movement of the weak limb.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This research project is a study designed to address both motor and cognitive changes after stroke, two common stroke disabilities. For example: two third of patients reported loss of upper limb function as a major problem after stroke and spatial neglect occurs in more than 350,000 US right hemisphere stroke survivors annually. These two impairments if not treated, lead to immediate impairment in basic life activities, long term functional disability, increased risk for falls and increased healthcare costs. The literature displays many strong research studies that trialed the use of multiple treatment approaches to remediate spatial neglect, including prism adaptation treatment (PAT), resulting in positive results. Similar findings result for treatment studies that attempt to remediate the upper extremity (UE). However, in all group of patients that were tested in these studies (both for spatial neglect and UE dysfunction) only had one stroke and past medical histories that were unremarkable. Rehabilitation professionals help clients that have had all types of strokes achieve improved quality of life by helping to increase independence by remediating impairment. In addition, these professionals need to know more about the effects of PAT in stroke survivors with multiple lesions because these are patients commonly being treated in the clinical setting. Also, it has not been investigated whether using PAT, a very promising and easy to administer treatment, to remediate spatial neglect will also increase spontaneous UE movement of the limb affected by the stroke because of an influence on motor-intentional aiming errors. Thus, in this pilot research proposal, the researcher intends to first investigate the feasibility of this two week treatment on stroke survivors that have had multiple lesions and second verify if PAT will improve spatial neglect and jointly increase spontaneous movement of the UE.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Saddle Brook, New Jersey, United States, 07663
        • Kessler Insitute for Rehabilitaiton
      • West Orange, New Jersey, United States, 07052
        • Kessler Institute for Rehabiltiation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Between the ages of 18 and 90.
  • New stroke on the right side of the brain.
  • Has an UE impairment of the arm affected by the stroke (WMFT score of less than 75).
  • Has the presence of spatial neglect (greater than 1 on the KF-NAP).
  • Is able to give informed consent.
  • Past medical history includes having had a stroke or more than one. This can be ischemic or hemorrhagic, and on either side of the brain.

Exclusion Criteria:

  • Is under the age of 18.
  • Has severe communication deficit.
  • Has a left brain stroke as the primary diagnosis and/or the primary diagnosis is anything other than stroke.
  • Is blind in one or both eyes.
  • Is not staying at the inpatient rehabilitation hospital
  • Has a cognitive impairment that inhibits their ability to recall information.
  • Has severely impaired upper extremity function in bilateral arms (cannot participate in the prism task).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Prism Adaptation
Prism Adaptation Treatment is 20 minutes long, administered 10 consecutive days
Behavioral: Prism Adaptation
PAT uses wedged prism lenses to displace the entire visual field horizontally to the left or right (depending on the orientation of the base of the prism). The left-base prism lenses (thicker on the left) shift the entire visual field to the right. The result is a curving reaching trajectory, aiming toward the image location (right to the actual location) and then corrected toward the actual location. After several reaching movement, the coordinates of motor and visual systems are aligned, which in other words, is that the motor output adapts to the visual input, and thus the reaching trajectory is straight ahead to the object. This visually-guided goal-oriented movement is essential in PAT.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
CBS via Kessler Foundation Neglect Assessment Process
Time Frame: 30 minutes
The CBS is a 10-item scale for evaluating the severity of spatial neglect (Azouviet al., 1996). Thus, the CBS captures the heterogeneity of spatial neglect in the most functional way. The items include limb awareness, personal belongings, dressing, grooming, gaze orientation, auditory attention, navigation, collisions, eating, cleaning after a meal. Each item is scored from 0-3. Based on a CBS total score (range 0-30), a stroke survivor with unilateral brain damage can be categorized as no neglect (CBS=0), mild (CBS= 1-10), moderate (CBS= 11-20), or severe (CBS= 20-30). In 2012, Chen et al. addressed this obstacle by standardizing the method to use the CBS reliably in the clinic and trademarked the process to use in conjunction with the CBS as the Kessler Foundation Neglect Assessment Process (CBS via KF-NAP™).
30 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Behavior Inattention Test
Time Frame: 15 minutes
The Behavior Inattention Test is a validated, widely used battery for the assessment of neglect. It has multiple subtests in the conventional battery, for example line crossing and letter cancelation tests . The conventional test battery will be used; the total score is out of 146 with a cut off score of 128 for spatial neglect (Wilson, et al. 1987).
15 minutes
Motor Activity Log
Time Frame: 15 minutes
The Motor Activity Log, a structured interview, will be used to assess how the patient feels they use their arm during specific activities (Uswatte, Taub, Morris, Vignolo, McCulloch, 2005). This will be the outcome measure used to determine spontaneous movement.
15 minutes
Functional Independence Measure
Time Frame: 30 minutes
Functional Independence Measure (FIM) is a reliable and valid assessment of function and the gold standard in rehabilitation facilities. It consists of 18 items assessing the level of independence in two domains; motor and cognitive. Each item is scored from 1 (maximal) to 7 (independent) (Ottenbacher, et al 1996).
30 minutes
Wolf Motor Function Test
Time Frame: 45 min
The WMFT is a quantitative measure of upper extremity motor ability through timed and functional tasks (Wolf et al., 1989). There are 21 items with 3 parts (time, functional ability and strength). The person's less affected arm is examined followed by the most affected side. The maximum score is a 75.
45 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kessler Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kimberly P Hreha, MS, Kessler Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R-853-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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