Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT03357042 |
| Other study ID # |
RP-506-07112017 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 8, 2018 |
| Est. completion date |
April 2020 |
Study information
| Verified date |
August 2019 |
| Source |
Lakehead University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
A concussion occurs when a person receives an impact to the head. The most common persistent
symptoms that generate from a concussion are headaches, depression, lack of balance and
dizziness. One recommendation to alleviate persistent symptoms of concussion is rest.
Research findings indicate that the benefit of rest is inconclusive to help individuals
suffering from a concussion return to activities of daily living. One treatment approach in
reducing concussion symptoms is physical exercise therapy. Research findings, however, are
limited to treatments being administered before the symptoms are considered persistent. Based
on this rationale, the aim of this study is to examine the effect of a physical therapy
intervention in minimizing persistent symptoms of concussion using measures of cognition and
brain function, mental and physical health, and driving performance. If successful, this
physical therapy intervention may help treat persistent concussion symptoms, improving the
quality of life and ability for individuals to function normally in their daily lives, and
resulting in savings to the healthcare system
Description:
Recruitment will include the use of posters, social media, and word of mouth. Posters
designed to recruit healthy individuals free of a concussion will be displayed around
Lakehead University, as well as various public spaces in Thunder Bay. Separate posters
(attached) will also be used to recruit persons who have sustained a concussion in the
previous two weeks to six months and are still experiencing symptoms (Persistent
Post-concussive symptoms; PCS). These posters will be displayed at Fairway Physiotherapy and
healthcare clinics around Thunder Bay. All posters will be shared on Lakehead University
School of Kinesiology social media pages.
Prior to participating in the study, all participants will have a medical examination with
Dr. Wark at least two weeks following the initial injury. If the potential participant
expresses interest in the study, his/her information will be passed along to a member of the
research team. A member of the research team will contact the potential participant to
schedule pre intervention assessments based on the participant's, research team, and lab
availability. Participants will also be provided with a copy of the information letter at
this time. Any medical screening tools will be kept by Dr. Wark as part of the patient's
medical records, regardless of eligibility for the study. Any information taken from these
records will be recorded using a data abstraction form.
Healthy and PCS participants will be scheduled for pre intervention physical, cognitive,
neuroimaging, biomarker, and driving behaviour assessments at Lakehead University. All pre
intervention assessments will be completed over the course of one week. At the first session,
a member of the research team will complete the informed consent process; participants will
be provided with a verbal overview of the study and the information letter. Following the
informed consent process, healthy participants will complete the short form International
Physical Activity Questionnaire.
Following the informed consent process, PCS participants will be provided with Garmin
VivoSmart heart rate (HR) unit to monitor aerobic activity outside of the study
(accelerometer, heart rate monitor, and step counter capabilities). Participants will be
required to wear the Garmin units as often as possible for the duration of the study.
Depending on scheduling, participant's will then complete one of the baseline assessments.
Baseline Assessments
Physical and Cognitive Assessment:
Participants will complete the Immediate Post-concussion Assessment and Cognitive Testing
(ImPACT) at the School of Kinesiology, Sanders building, Lakehead University. The ImPACT will
be used as a question and answered based, standard measure of cognitive abilities including:
attention, working memory, processing speed, and reaction time. Following completion of the
ImPACT battery, participants will be asked to stand in a variety of static positions
including: narrow based double leg stance, single leg stance, and tandem stance with one foot
behind the other. Participants will perform each stance position with his/her eyes open and
closed and on a firm and soft surface using the Balance Error Scoring System (BESS) protocol.
Each stance will be performed over an Advanced Medical Technologies Incorporated (AMTI) force
platform. The session should last approximately one hour.
Biomarker Assessment:
Brain-derived neurotropic factor (BDNF) will be assessed using a morning saliva sample.
Participants will be asked to refrain from brushing his/her teeth, smoking, and consuming
food or drink within two hours of the sample collection. Participants will also be asked to
avoid alcohol consumption 12 hours prior to sampling. At a mutually agreed upon date and
time, the participant will meet a member of the research team at the School of Kinesiology,
Sanders building, Lakehead University. Before beginning saliva collection, the member of the
research team will verbally restate the participant's rights and confirm that he/she is still
willing to participate in the study. Saliva will then be collected from participants in room
SB-1025 (biohazard containment level 1) via the passive drool method into a tube, which will
then be transported to Dr. Lees lab for processing.
Neuroimaging:
Neural processing will be assessed by using continuously recorded electroencephalography
(EEG) during the performance of computer based tasks commonly used in experimental psychology
for assessing divided attention and inhibitory control. Participants will be seated at a desk
and fitted with an EEG cap and 32 channels will be prepared with gel. Once all recording
sites are ready for recording the participant will be familiarized with the task procedures
and equipment. At the desk he/she is seated at, he/she will view a monitor and be provided
with a response pad. Participants will complete the Oddball paradigm and Flanker task.
Completion of the session should require two hours.
Tasks:
ODDBALL paradigm:
The Oddball paradigm is a commonly used task to test attention by requiring participants to
make a specific response to rare target stimuli amongst more repetitive, distractor stimuli
(Squires, Squires, & Hillyard, 1975). In this visual version, participants will be provided
an instruction at the outset of a block that indicates what the target stimulus for that
block will be. During each trial, a stimulus (shape/letter) will be displayed for 200
milliseconds (ms). Participants will be instructed to respond to each stimulus as quickly and
accurately as possible with a button press of one of two buttons; a button to denote
distractor stimuli, and a button to indicate target stimuli. The interstimulus interval will
be variable (1400-1600 ms) to reduce anticipation. Participants will complete 400 trials
separated into 5 blocks with an option for rests between each block.
FLANKER task:
The Flanker task is commonly used to test the ability to attend to central relevant
information (the direction of an arrow) while disregarding irrelevant distracting stimuli
(pairs of flanking arrows presented on either side of the central arrow). To identify the
direction of the central arrow, participants will press a left or right button to indicate
the direction of the central arrow. Data will be separated into time frames containing the
components of interest (the N200 and P300). The session is concluded after completion of the
oddball and flanker tests twice.
Behaviour Measure (Driving Simulator):
The performance of participants in a driving simulator will be assessed by measuring his/her
reaction time and counting the number of passes and failures when anticipating potentially
dangerous traffic situations. Reaction time will also be measured during dual-tasking
activities.
Participants will perform a 10 minute orientation drive to familiarized his/herself with the
control and feel of the driving simulator. During the orientation drive, he/she will be
exposed to examples of the dual tasking activities so that he/she will know how to
successfully respond to the prompts. Once a participant feels comfortable with the simulator,
the 20 minute simulation and data collection will begin. The simulation will be based on the
Thunder Bay road system with traffic and pedestrians present. Weather will be clear and
visibility will not be reduced. Reaction times will be measured during predetermined
scenarios and will be recorded from the moment stimulus occurs to the moment the brake is
depressed or evasive maneuver performed. Participants will be exposed to several scenarios.
These scenarios include: Vehicle incursion at intersection, pedestrian incursion from side of
the road, sudden braking by a vehicle in front of participant, pedestrian incursion in school
zone, braking by a vehicle in front of participant, and animal incursion (attached)
During dual task events, red triangles will be displayed over either of the side mirrors.
These triangles will be deactivated by the press of a button on either side of the steering
column, accounting for the dual tasking component of the reaction time scenarios The research
team member will have water on hand, if required by the participant. When he/she feels ready
to proceed, the simulation will be resumed from the point of the original pause. If a
participant feels that he/she is unable to continue, the simulation will be stopped and data
collection terminated.
Randomization Prior to the implementation of the interventions, PCS participants will be
randomly assigned to either an AET or standard of care (SC) intervention. Using minimization
software, each intervention group will be balanced by sex and age. Healthy participants will
serve as the control group (HC) and will receive no treatment. Once participants in the SC
group have completed the study, the AET will be offered, although it will not be included in
the data analysis. All participant information/group assignment will be coded to maintain
confidentiality.
Aerobic and Balance Retraining Program:
After completing baseline assessments, PCS participants assigned to the aerobic and balance
retraining (AET) intervention will complete an eight week supervised AET program. The program
will consist of three sessions per week, approximately 40-60 minutes each. Each session will
be performed under the supervision of a trainer that has the Canadian Society for Exercise
Physiology (CSEP-CPT) certification.
The aerobic component of the session will be performed on a cycle ergometer. Participants
will begin with a five minute warmup at a self selected speed, which will be used to bring
the participant's heart rate to the desired intensity. Intensity for each session will start
at 20% of heart rate reserve (HRR), and increase linearly by 10% for the first four weeks; at
week four, participants will be cycling at an intensity of 50%. Weeks five and six will be
performed at 55% of HRR, week seven will be performed at 60% of HRR, and week eight will be
performed at 65% of HRR. Duration will follow a similar pattern for weeks one to four,
beginning at 20 minutes and increasing in five minutes/week increments. At week five,
duration will be reduced to 25 minutes, and then increase to 30 minutes for weeks six to
eight.
Following completion of the aerobic portion of the session, participants will rest for five
minutes before beginning the balance component of the session. Participants will perform
three balance exercises (in order) each session: narrow based double leg stance, single leg
stance, and tandem stance. Difficulty of these exercises will be progressively increased by
modifying the duration, surface, and whether the participant's eyes are open or closed. For
weeks one and two participants will perform the exercises with his/her eyes open;
participants will perform each exercise for 15 seconds on a firm service in week one, and on
a low density foam block in week two. In weeks three and four, participants will perform the
exercises with his/her eyes closed; exercises in week three will be performed on a firm
surface, while week four will be performed on a low density foam block. Duration will be
increased to twenty seconds per exercise for weeks three and four. Weeks four to eight will
follow the same eyes open/closed and surface progression as weeks one to four; eyes open for
weeks five and six, eyes closed for weeks seven and eight. Exercises will be performed on a
firm surface in weeks five and seven, and on a low density foam block in weeks six and eight.
Participants will perform each exercise for 35 seconds in weeks five and six, and 40 seconds
in weeks seven and eight. Following the completion of the aerobic and balance components of
the session, participants will complete a cool down consisting of a series of static
stretches. Each session will conclude after the completion of the cooldown.
After completion of 24 sessions (eight weeks x three-one hour sessions per week),
participants will repeat the procedures for the previously described baseline assessments.
Similarly, HC and SC participants will complete the baseline assessments again after eight
weeks.
