Clinical trial NCT02680171: Feasibility and Effectiveness Study of Implementing Prism Adaptation as a Treatment for Spatial Neglect After Stroke
Official title: Feasibility and Effectiveness Study of Implementing Prism Adaptation as a Treatment for Spatial Neglect After Right Hemisphere Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sensory Neglect
Stroke
Keywords: Cognitive Rehabilitation
Prism Adaptation
Stroke
Spatial Neglect
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2016-02-11
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Sunnybrook Neglect Assessment Procedure (SNAP)
timeFrame: Taken at baseline and after the intervention has been completed (approximately two weeks post-treatment start)
Secondary outcomes:
measure: Change in Johnny Shirt Visual Scanning Task
timeFrame: 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)
measure: Change in Behavioural Inattention Test - Behaviour subtests (BIT-B)
timeFrame: Taken at baseline and after the intervention (approximately two weeks post-treatment start)
measure: Change in Catherine Bergego Scale (CBS)
timeFrame: Taken at baseline and after the intervention (approximately two weeks post-treatment start)
measure: Change in Halifax Neglect Severity Scale
timeFrame: 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)
measure: Change in Functional Independence Measure (FIM)
timeFrame: Taken at baseline and at discharge up to 3 months
measure: Frenchay Activities Index
timeFrame: Taken at approximately 3 months post-discharge
measure: Length of inpatient stay at the Rehabilitation Centre
timeFrame: From admission to discharge up to 3 months
measure: Discharge destination from Rehabilitation Centre
timeFrame: At time of discharge up to 3 months from admission
measure: Change in Proprioceptive and Visuo-motor pointing midline tasks
timeFrame: Taken from immediately before and at end of treatment session, about 10 minutes
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Health Authority; Dalhousie University
name: Gail A Eskes, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nova Scotia Health Authority
name: Richard Braha, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dalhousie University; Acadia University
name: Anne Sophie Champod, PhD
role: STUDY_CHAIR
affiliation: Nova Scotia Health Authority
name: Joy Boyce, BScOT
role: STUDY_CHAIR
affiliation: Nova Scotia Health Authority
name: Myrna King, BScOT
role: STUDY_CHAIR
References:
citation: 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.
citation: Longley V, Hazelton C, Heal C, Pollock A, Woodward-Nutt K, Mitchell C, Pobric G, Vail A, Bowen A. Non-pharmacological interventions for spatial neglect or inattention following stroke and other non-progressive brain injury. Cochrane Database Syst Rev. 2021 Jul 1;7(7):CD003586. doi: 10.1002/14651858.CD003586.pub4.