NCT05506241

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

1.3 years

First QC Date

August 16, 2022

Last Update Submit

November 20, 2023

Conditions

StrokeAcute Brain Injury

Keywords

Visual scanning trainingLeft neglect

Outcome Measures

Primary Outcomes (2)

  • Mean change from baseline score on Catherine Bergego Scale after 10 therapy sessions

    The Catherine Bergego Scale is a standardized tool to detect presence and degree of neglect during observation of everyday life situations. It is a 10-item scale, with each item, scored from 0-3, measuring no neglect up to severe neglect.

    ~3 weeks from baseline

  • Mean change from baseline score on Catherine Bergego Scale after 20 therapy sessions

    The Catherine Bergego Scale is a standardized tool to detect presence and degree of neglect during observation of everyday life situations. It is a 10-item scale, with each item, scored from 0-3, measuring no neglect up to severe neglect.

    ~5-6 weeks from baseline

Secondary Outcomes (4)

  • Mean change from baseline score on Star Cancellation Test after 10 therapy sessions

    ~3 weeks from baseline

  • Mean change from baseline score on Star Cancellation Test after 20 therapy sessions

    ~5-6 weeks from baseline

  • Mean change from baseline score on Letter Cancellation Test after 10 therapy sessions

    ~3 weeks from baseline

  • Mean change from baseline score on Letter Cancellation Test after 20 therapy sessions

    ~5-6 weeks from baseline

Study Arms (2)

Repetitive Visual Scanning Training

EXPERIMENTAL

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.

Device: Dynavision D2

Usual Treatment

NO INTERVENTION

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

Interventions

Dynavision D2DEVICE

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.

Repetitive Visual Scanning Training

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Providence Care Hospital

Kingston, Ontario, K7L 4X3, Canada

RECRUITING

MeSH Terms

Conditions

StrokeBrain Injuries

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Central Study Contacts

Teresa Broers, OT

CONTACT

613-544-4900broerst@providencecare.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Occupational Therapist

Study Record Dates

First Submitted

August 16, 2022

First Posted

August 18, 2022

Study Start

May 1, 2023

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

November 22, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)