NCT02419222

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 17, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 21, 2017

Status Verified

August 1, 2017

Enrollment Period

1.9 years

First QC Date

April 14, 2015

Last Update Submit

August 16, 2017

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • 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™).

    30 minutes

Secondary Outcomes (4)

  • Behavior Inattention Test

    15 minutes

  • Motor Activity Log

    15 minutes

  • Functional Independence Measure

    30 minutes

  • Wolf Motor Function Test

    45 min

Study Arms (1)

Prism Adaptation

EXPERIMENTAL

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

Behavioral: Prism Adaptation

Interventions

Prism AdaptationBEHAVIORAL

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.

Prism Adaptation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kessler Insitute for Rehabilitaiton

Saddle Brook, New Jersey, 07663, United States

Location

Kessler Institute for Rehabiltiation

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Kimberly P Hreha, MS

    Kessler Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2015

First Posted

April 17, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

August 21, 2017

Record last verified: 2017-08

Locations

US(2)