Feasibility and Effectiveness Study of Implementing Prism Adaptation as a Treatment for Spatial Neglect After Stroke

Stroke Clinical Trial

Official title:

Feasibility and Effectiveness Study of Implementing Prism Adaptation as a Treatment for Spatial Neglect After Right Hemisphere Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02680171
• Other study ID #: TRICSpatialNeglect2016
• Status: Completed
• Phase: N/A
• Start date: February 6, 2018
• Est. completion date: August 30, 2021

Study information

• Verified date: June 2023
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Spatial neglect is a common attention disorder after right hemisphere stroke and is associated with decreased independence and quality of life. Despite its high prevalence in the stroke population, there is currently no standard of care for the treatment of neglect. Prism adaptation (PA) is a promising rehabilitation technique, however incorporation into clinical care has been limited likely due to the lack of standardized procedures. The investigators have developed a computerized PA technique designed to better engage patients and assist clinicians. In this study the investigators aim to evaluate the feasibility and effectiveness of the computerized PA procedure in a typical health care setting, with the hypothesis that the PA procedure will improve patient's neglect symptoms.

Description:

There is an unmet need for effective and feasible interventions for spatial neglect after right hemisphere stroke. Neglect is a frequent problem after stroke and makes it difficult for individuals to pay attention and notice information coming from the left side of their world. Thus, they often miss food on the left side of their plate, fail to wash or groom the left side of their face or body, or run into objects on the left side of the hall when walking or using their wheelchair. Neglect is associated with slower recovery, reduced independence, longer stays in rehabilitation and need for more resources when discharged. The investigators have developed a novel and simple computerized prism adaptation (PA) procedure for treating neglect, but the investigators don't know yet whether it is feasible and effective in a typical health care setting. Thus, the purpose of this project is to conduct a randomized, controlled clinical trial, comparing the PA method to a control intervention for the treatment of neglect. The investigators will measure feasibility of use in a clinical setting and effectiveness in terms of impairment (i.e., does PA improve neglect symptoms?), activities (i.e., does having PA improve independence in daily activities) and health care outcomes (i.e., does giving PA shorten length of stay and decrease the need for resources on discharge?). By treating neglect with PA, the overall aim is to improve the health care outcomes for those with neglect and to reduce need for extended hospital care.

A controlled, randomized design will be used in the present study. Patients will be randomly assigned (with stratification related to neglect severity) to PA (experimental) or sham (control) conditions and complete 10, 30-minute intervention sessions over approximately two weeks. These intervention sessions will involve a novel and simple computerized prism adaptation, Peg-The-Mole (PTM). Outcome measures will be collected before and after each treatment, as well as at baseline, and a three month follow-up over the phone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 30, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Experience mild to severe symptoms of neglect (as measured by the Sunnybrook Neglect Assessment Procedure and/or as determined based on clinical judgment of the treating team)

• Be willing to participate

• Be able to consent to participate

• Be medically stable

• Have normal or corrected to normal vision

• Be able to point to targets presented on a computer screen.

Exclusion Criteria:

• Other neurological disease (e.g., Multiple Sclerosis, Parkinsons disease)

• Dementia

Related Conditions & MeSH terms

• Perceptual Disorders
• Sensory Neglect
• Stroke

Intervention

Behavioral:
• Prism Goggles
Patients in the experimental condition will wear prism goggles while completing a computerized aiming task. This prisms will shift the patients' vision 10 degrees rightward, causing a recalibration of visuo-motor information. Prism adaptation will be carried out over several days.

Other:
• Non-Shifting Goggles
Non-shifting goggles are worn instead of prism goggles, while completing the same computerized aiming task as those assigned to the prism adaptation.

Locations

Country	Name	City	State
Canada	Nova Scotia Health Authority	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Champod AS, Taylor K, Eskes GA. Development of a new computerized prism adaptation procedure for visuo-spatial neglect. J Neurosci Methods. 2014 Sep 30;235:65-75. doi: 10.1016/j.jneumeth.2014.05.023. Epub 2014 Jun 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Sunnybrook Neglect Assessment Procedure (SNAP)	Test of neglect severity	Taken at baseline and after the intervention has been completed (approximately two weeks post-treatment start)
Secondary	Change in Johnny Shirt Visual Scanning Task	Test of neglect severity	Taken at baseline, after five intervention sessions are completed (approximately 1 week post-treatment start), and after the intervention (approximately two weeks post-treatment start)
Secondary	Change in Behavioural Inattention Test - Behaviour subtests (BIT-B)	Test of neglect severity	Taken at baseline and after the intervention (approximately two weeks post-treatment start)
Secondary	Change in Catherine Bergego Scale (CBS)	Scale of neglect impact on daily activities	Taken at baseline and after the intervention (approximately two weeks post-treatment start)
Secondary	Change in Halifax Neglect Severity Scale	Scale of neglect impact on daily activities	Taken after the intervention (approximately two weeks post-treatment start) and at follow-up (approximately 3 months post-discharge from the Nova Scotia Rehabilitation and Arthritis Centre)
Secondary	Change in Functional Independence Measure (FIM)	Measure of functional independence	Taken at baseline and at discharge up to 3 months
Secondary	Frenchay Activities Index	Measure of functional independence	Taken at approximately 3 months post-discharge
Secondary	Length of inpatient stay at the Rehabilitation Centre	Measure of hospital utilization	From admission to discharge up to 3 months
Secondary	Discharge destination from Rehabilitation Centre	Measure of hospital utilization	At time of discharge up to 3 months from admission
Secondary	Change in Proprioceptive and Visuo-motor pointing midline tasks	Used to assess prism adaptation after-effects	Taken from immediately before and at end of treatment session, about 10 minutes