StrokeNCT04977219
Prism Adaptation Training for Treatment of Spatial Neglect During Inpatient Rehabilitation
An observational study of Stroke, run by Sunnyview Rehabilitation Hospital.
Trial summary
Left sided spatial neglect is a common yet potentially debilitating phenomena associated with right hemisphere stroke. Heilman defines neglect as "the failure to report, respond, or orient to novel or meaningful stimuli presented to the side opposite of a brain lesion that cannot be attributed to either sensory or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Prism Adaptation Training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatient Rehabilitation Facility (IRF)
Who may be able to join
- Right hemisphere stroke
- Admitted between 6/2016 \& 12/2019
Who cannot join
- Absence of neglect
- Incomplete Catherine Bergego Scale (Less than 7 items scored)
- Evidence of traumatic brain injury
- Brain cancer
- Dementia
- Parkinson's disease
Show all 9Show fewer
- Alzheimer's disease
- aphasia
- Interrupted hospital admission
About this study
Left sided spatial neglect is a common yet potentially debilitating phenomena associated with right hemisphere stroke. Heilman defines neglect as "the failure to report, respond, or orient to novel or meaningful stimuli presented to the side opposite of a brain lesion that cannot be attributed to either sensory or motor deficits". Numerous studies have demonstrated the impact of spatial neglect in right hemisphere stroke patients on both rehabilitation outcomes, and subsequent functioning in the community. Given the highly significant negative impact of spatial neglect, numerous treatment approaches have been attempted, yet most lack evidence in terms of efficacy. One promising exception has been prism adaptation training (PAT), which several recent reviews reported improved independence as a benefit of this treatment, both in terms of ameliorating the severity of neglect and demonstrating generalization to important functional behaviors. Still, much remains unknown regarding PAT, and not all studies have shown positive results.
At Sunnyview Rehabilitation Hospital, a number of providers have added PAT to the standard PT, OT and speech that stroke patients receive during their inpatient stay. As part of a process improvement initiative the investigators identified 57 patients that received PAT training between June 2016 and September of 2019. The investigators propose a retrospective case-control study examining the impact of PAT treatment on the rehabilitation outcomes for these patients. Outcome variables to be assessed include the measures of spatial neglect (Catherine Bergego Scale), functional independence measures (FIM), length of hospitalization and discharge destination. The investigators hypothesize that patients who received 4 or more PAT sessions during their inpatient rehabilitation stay will show improvements both in measures of neglect and functional independence as a result of this treatment.
- Conditions
- Stroke
- Being tested
- Prism Adaptation Training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prism Adaptation TrainingBehavioural
Therapists administering PAT followed the protocol developed by the Kessler Foundation (2014).PAT sessions lasted approximately 30 minutes during which patients with left sided neglect don 20 diopter prism goggles deviating their visual field to the right while aiming their finger at a series of visual targets.
| Study group | Role | What they receive |
|---|---|---|
| Prism Adaptation Training; | Patients who received prism adaptation training for treatment of spatial neglect during their inpatient rehabilitation admission Receives: Behavioral: Prism Adaptation Training | |
| Standard Care | Patients who received standard treatment of spatial neglect during their admission |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catherine Bergego Scale
Behavioral measure of unilateral spatial neglect. Scored 0-30. Higher numbers indicate greater severity of spatial neglect.
Measured: Up to 55 days
Secondary outcomes (3)
Functional Independence Measure (FIM)
Measure of motoric and behavioral functioning of patients (eating, toileting, dressing, mobility). Scores range from 18-126. Higher scores indicate greater functional independence.
Measured: Up to 55 days
Length of Stay
Length of inpatient hospital admission
Measured: Up to 55 days
Discharge destination
Destination of patient following discharge: Home, Subacute nursing facility, Acute care hospital
Measured: Up to 55 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start1 Jun 2016
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnyview Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Gillen, Sunnyview Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977219
- Sponsor's protocol ID
- 21-0505-3
- Status last verified
- Jul 2021
- First submitted
- 9 Jul 2021
- Last updated
- 26 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gillen RW, Harmon EY, Weil B, Fusco-Gessick B, Novak PP, Barrett AM. Prism Adaptation Treatment of Spatial Neglect: Feasibility During Inpatient Rehabilitation and Identification of Patients Most Likely to Benefit. Front Neurol. 2022 Apr 1;13:803312. doi: 10.3389/fneur.2022.803312. eCollection 2022.
PubMed 35432163
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prism Adaptation Training for Treatment of Spatial Neglect During Inpatient Rehabilitation
- ClinicalTrials.gov ID
- NCT04977219
- Acronym / sponsor ID
- 21-0505-3
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Sunnyview Rehabilitation HospitalUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 26 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Left sided spatial neglect is a common yet potentially debilitating phenomena associated with right hemisphere stroke. Heilman defines neglect as "the failure to report, respond, or orient to novel or meaningful stimuli presented to the side opposite of a brain lesion that cannot be attributed to either sensory or motor deficits". Numerous studies have demonstrated the impact of spatial neglect in right hemisphere stroke patients on both rehabilitation outcomes, and subsequent functioning in the community. Given the highly significant negative impact of spatial neglect, numerous treatment approaches have been attempted, yet most lack evidence in terms of efficacy. One promising exception has been prism adaptation training (PAT), which several recent reviews reported improved independence as a benefit of this treatment, both in terms of ameliorating the severity of neglect and demonstrating generalization to important functional behaviors. Still, much remains unknown regarding PAT, and not all studies have shown positive results.
At Sunnyview Rehabilitation Hospital, a number of providers have added PAT to the standard PT, OT and speech that stroke patients receive during their inpatient stay. As part of a process improvement initiative the investigators identified 57 patients that received PAT training between June 2016 and September of 2019. The investigators propose a retrospective case-control study examining the impact of PAT treatment on the rehabilitation outcomes for these patients. Outcome variables to be assessed include the measures of spatial neglect (Catherine Bergego Scale), functional independence measures (FIM), length of hospitalization and discharge destination. The investigators hypothesize that patients who received 4 or more PAT sessions during their inpatient rehabilitation stay will show improvements both in measures of neglect and functional independence as a result of this treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prism Adaptation Training; | – | Behavioral: Prism Adaptation TrainingPatients who received prism adaptation training for treatment of spatial neglect during their inpatient rehabilitation admission |
| Standard Care | – | –Patients who received standard treatment of spatial neglect during their admission |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatient Rehabilitation Facility (IRF)
Key inclusion criteria (2 listed)
- Right hemisphere stroke
- Admitted between 6/2016 \& 12/2019
Key exclusion criteria (9 listed)
- Absence of neglect
- Incomplete Catherine Bergego Scale (Less than 7 items scored)
- Evidence of traumatic brain injury
- Brain cancer
- Dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prism Adaptation TrainingTherapists administering PAT followed the protocol developed by the Kessler Foundation (2014).PAT sessions lasted approximately 30 minutes during which patients with left sided neglect don 20 diopter prism goggles deviating their visual field to the right while aiming their finger at a series of visual targets. | Behavioural | Prism Adaptation Training; |
Primary outcome
Catherine Bergego Scale
Time frame: Up to 55 days
Behavioral measure of unilateral spatial neglect. Scored 0-30. Higher numbers indicate greater severity of spatial neglect.
3 secondary outcomes
Functional Independence Measure (FIM)
Time frame: Up to 55 days
Length of Stay
Time frame: Up to 55 days
Discharge destination
Time frame: Up to 55 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
- Derived from this study: PubMed 35432163Gillen RW, Harmon EY, Weil B, Fusco-Gessick B, Novak PP, Barrett AM. Prism Adaptation Treatment of Spatial Neglect: Feasibility During Inpatient Rehabilitation and Identification of Patients Most Likely to Benefit. Front Neurol. 2022 Apr 1;13:803312. doi: 10.3389/fneur.2022.803312. eCollection 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Sunnyview Rehabilitation Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Catherine Bergego Scale (time frame: Up to 55 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04977219, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2021.