Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05506241 |
Other study ID # |
57281 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 1, 2023 |
Est. completion date |
September 1, 2024 |
Study information
Verified date |
November 2023 |
Source |
Queen's University |
Contact |
Teresa Broers, OT |
Phone |
613-544-4900 |
Email |
broerst[@]providencecare.ca |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.