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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prism Adaptation
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Kessler Insitute for Rehabilitaiton
  • Kessler Institute for Rehabiltiation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prism Adaptation

Arm Description

Prism Adaptation Treatment is 20 minutes long, administered 10 consecutive days

Outcomes

Primary Outcome Measures

CBS via Kessler Foundation Neglect Assessment Process
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™).

Secondary Outcome Measures

Behavior Inattention Test
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).
Motor Activity Log
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.
Functional Independence Measure
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).
Wolf Motor Function Test
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.

Full Information

First Posted
April 14, 2015
Last Updated
August 16, 2017
Sponsor
Kessler Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02419222
Brief Title
Feasibility of Using Prism Adaptation to Treat Spatial Neglect and Motor Function in Stroke
Official Title
Feasibility of Using Prism Adaptation to Treat Spatial Neglect and Motor Function in Stroke Survivors With Multiple Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kessler Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prism Adaptation
Arm Type
Experimental
Arm Description
Prism Adaptation Treatment is 20 minutes long, administered 10 consecutive days
Intervention Type
Behavioral
Intervention Name(s)
Prism Adaptation
Intervention Description
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.
Primary Outcome Measure Information:
Title
CBS via Kessler Foundation Neglect Assessment Process
Description
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™).
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Behavior Inattention Test
Description
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).
Time Frame
15 minutes
Title
Motor Activity Log
Description
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.
Time Frame
15 minutes
Title
Functional Independence Measure
Description
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).
Time Frame
30 minutes
Title
Wolf Motor Function Test
Description
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.
Time Frame
45 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly P Hreha, MS
Organizational Affiliation
Kessler Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kessler Insitute for Rehabilitaiton
City
Saddle Brook
State/Province
New Jersey
ZIP/Postal Code
07663
Country
United States
Facility Name
Kessler Institute for Rehabiltiation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States

12. IPD Sharing Statement

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

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