Effectiveness of the Dynavision Device to Improve Spatial Awareness After Brain Injury

NCT ID: NCT05506241

Last Updated: 2023-11-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-09-01

Brief Summary

The purpose of this research is to determine the effectiveness of using the Dynavision D2 to improve left neglect in adults with brain injury, and improve performance of ADLs/IADLs. This study will use a randomized control trial at Providence Care Hospital in Kingston Ontario, with clients admitted to the Stroke and ABI services who have been identified through the Catherine Bergego Scale (CBS) as having moderate to severe left neglect. Individuals will be randomly assigned to the control arm, where they will get the usual 60 minutes of OT treatment daily or the intervention arm, which is 30 minutes of their usual OT treatment and a 30 minute session of the Dynavision for 10 sessions for short stay inpatients (~ 3 weeks) and 20 sessions for clients with longer 5-6 week stay. The CBS will be used to measure change in neglect severity at three time points: baseline, following 10 sessions and following 20 sessions, for those that stay for longer.

Detailed Description

This study will be a randomized control trial that will take place at Providence Care Hospital in Kingston, Ontario. Eligibility screening will be completed by the OT and written consent will be in person prior to randomization. Individuals will be able to decline participation without impact upon their usual treatment and will be able to withdraw at any time, even if they originally consented to be included. Stratified block randomization will take place, stratified by moderate and severe neglect, to ensure there are equal numbers of moderate and severe in each study arm, given that this pilot study will have a small sample size. The study IDs will be blindly assigned to intervention (Dynavision sessions) and control (usual OT therapy) groups. The study ID information with the respective group allocation will be coordinated by the primary investigator. Treating Occupational Therapists and OT Assistants will carry out the interventions, as per the group allocations.

Participants will be included into the study based on results from the Catherine Bergego Scale (CBS), via the Kessler Foundation Neglect Assessment Process (KF-NAP). This tool will be administered to individuals within the first 3 workdays following admission. Any client who scores moderate or severe on the CBS will be considered for inclusion into the study. Two additional sub tests from the Behavioural Inattention Test (BIT), namely the Star Cancellation Test and the Letter Cancellation Test will also be used in individuals identified by the CBS to have moderate to severe neglect. The sub-tests from the BIT are crucial to offer a secondary measure of peri-personal inattention, and offers qualitative information regarding if clients are using an efficient left-right strategy to cancel targets or a more inefficient right-left, up-down, or random strategies. Together, the measures will qualify and quantify the degree of impairment pre- and post-intervention.

Individuals will be randomly assigned to the control arm, where they will get usual OT treatment for 60 minutes or the intervention arm that will include a defined treatment period using the Dynavision. Participants assigned to the intervention arm will have 30 minutes of their usual OT treatment session, in addition to a 30-minute session of the Dynavision. It is important for the Dynavision session to not be a session over and above their usual one hour of therapy, as the study aims to determine the utility of the Dynavision to improve neglect, rather than testing increased therapy time in general. Individuals in the control arm will use the Dynavision once per week for only 10-15 minutes - 5 rounds of 2 or 3 minutes, which is similar to what clients have been receiving since we acquired the Dynavision.

For the intervention arm, use of the Dynavision will be comprised of six 3-minute or nine 2-minute sessions with 30 seconds to one-minute rest in between. All Dynavision sessions require clients to scan the 4' by 4' vertical board and hit the lit targets one at a time. Participants will be able to depress targets with their left or right hand, in standing or sitting. There are several programs that can be used to ensure participants stay interested and engaged, and all will require scanning left and right and back to the left. They will receive education about visual scanning, and encouragement to use a "left-right" strategy or, if needed, a "lawn mower" strategy, to help them to scan left. Testing will take place at three points: three-four days after admission will be the baseline score for all clients, at three weeks, following 10 sessions of the Dynavision, and finally at 5-6 weeks, after 20 sessions of the Dynavision. This means all patients will be tested at 10 weeks, and the longer stay patients will have an additional test score at 20 weeks.

Conditions

Stroke; Acute Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Repetitive Visual Scanning Training

Participants will receive 30 minutes of their usual occupational therapy treatment and a 30 minute session of the Dynavision for 10 sessions for short stay inpatients (\~ 3 weeks) and 20 sessions for clients with longer 5-6 week stay.

Group Type: EXPERIMENTAL

Dynavision D2

Intervention Type: DEVICE

Use of the Dynavision will be comprised of six 3-minute or nine 2-minute sessions with 30 seconds to one-minute rest in between. All Dynavision sessions require clients to scan the 4' by 4' vertical board and hit the lit targets one at a time. Participants will be able to depress targets with their left or right hand, in standing or sitting.

Usual Treatment

Participants will receive the standard 60 minutes of occupational therapy treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dynavision D2

Use of the Dynavision will be comprised of six 3-minute or nine 2-minute sessions with 30 seconds to one-minute rest in between. All Dynavision sessions require clients to scan the 4' by 4' vertical board and hit the lit targets one at a time. Participants will be able to depress targets with their left or right hand, in standing or sitting.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Inpatient on stroke or acute brain injury service
• Medically stable
• Moderate-to-severe neglect, as determined by the Catherine Bergego Scale
• Motivated to participate in daily therapy
• Can physically and cognitively tolerate up to three hours of daily therapy from Occupational Therapy, Physiotherapy, and Speech Therapy

Exclusion Criteria

• N/A

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ontario Society of Occupational Therapists

UNKNOWN

Sponsor Role: collaborator

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

Teresa Broers

Occupational Therapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Providence Care Hospital

Kingston, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Teresa Broers, OT

Role: CONTACT

broerst@providencecare.ca

613-544-4900 ext. 53074

Facility Contacts

Teresa Broers, OT

Role: primary

broerst@providencecare.ca

613-544-4900 ext. x53074

Other Identifiers

57281

Identifier Type: -

Identifier Source: org_study_id