Stroke Clinical Trial
Official title:
Functional Engagement in Assisted Therapy Through Exercise Robotics
The investigators have assembled an integrated knowledge/technology/client team to develop a novel motion capture-based home therapy program for children with hemiparesis (cerebral palsy, acquired brain injury (ABI)) and older persons post-stroke. The investigators society needs new approaches to improve the quality of life for millions of Canadians. The method proposaed here is to combine low-cost motion capture devices, a bimanual training program, social media frameworks such as Facebook Games, and on-line performance sharing between therapy clients and with their therapists. The investigators believe that together these approaches will yield interventions for people with stroke and children with hemiplegia that significantly improve their motivation to continue their exercise programs and thus improve their functional ability which will lead to improved quality of life.
A) Purpose:
The similarity of functional impairments in the two target hemiplegic populations, teenagers
with hemiparetic cerebral palsy CP or acquired brain injury (post-acute phase) and
hemiparetic stroke survivors, leads us to pursue a unified rehabilitation strategy. Although
age-dependency is clearly a factor in rate of motor learning, intensive therapies have shown
similar returns of function with similar intensities and length of treatment across
different populations [1]. By involving both adults and children in the same study, the
investigators can directly compare the effects of identical interventions using the
innovative hardware and software solutions that are developed.
The team of investigators have developed a system that includes a camera (PS3 Eye), 2
modified PS3 Move controllers, and a computer [2]. A software is designed to search through
the camera feed to find the glowing balls attached to the two PS3 Move controllers, and
changes the position of the computer's mouse cursor based on the position of the two glowing
balls. This allows the participants to play simple 2D Facebook games that involve
point-and-click by holding on to the Move controllers and moving their arms in space in
order to control the cursor and play games.
B) Hypothesis:
The investigators hypothesize that the following strategies will deliver effective,
long-term therapy: (1) use a bimanual approach, based on recent research that shows the
powerful integrative value of involving both limbs and both cerebral hemispheres in recovery
of function post-stroke [3]; (2) target hand-function, following the proven efficacy of this
approach (CIMT and GRASP) over exercising arm motions only; (3) directly target patient
motivation by embedding the therapy in a social construct of multi-user online gaming such
as Facebook Games [4, 5].
C) Justification:
The quality of life of Canadians with stroke declined from 1998 to 2005, a disturbing
finding that is directly related to impaired arm function [6]. Traditional (standard)
physical therapy includes a range of interventions aimed at improving posture, joint range
of motion, muscle tone, muscle strength and motor control. However, no single approach has
been proven to have superior effectiveness over any other in upper or lower limb recovery.
These are sobering data that illustrate a critical need for novel interventions that will
improve function and lead to better quality of life for persons living with hemiplegia.
Motor rehabilitation programs based on low-cost exercise devices such as the Nintendo Wii,
Nike Fit and Microsoft Kinect have proven efficacy [5], but participants are required to be
in the same room at the same time. Online games such as Farmville on Facebook support
cooperative tasks, but there are no appropriate devices to support bimanual input. Our
approach will fill this gap by supporting collaborative, bilateral motor-learning that
involves force and movement therapy and social media effectively.
D) Objectives:
Our objective is to demonstrate that motivation in adherence to a therapy regimen can be
enhanced by the use of online games in conjunction with motion capture devices that require
the user to interact bimanually with the game. Our project has 4 phases, each with its own
milestones:
1. Start-up: In-clinic focus group meetings with rehabilitation professionals and
follow-on focus groups with therapy clients; design of hardware and software based on
the outcomes of these focus group meetings (months M1-M9). This phase is finished.
2. Pilot study: Hardware and software development (M10-12), followed by in-clinic
usability studies with adult stroke survivors and children with hemiplegia; development
of final hardware and software based on the outcomes of the usability studies;
integrative Knowledge Transition activities (months M7-M24). This phase is finished.
3. Home-based studies: Two parallel 6-month studies, one with adults and one with
teenagers (months M25-M30). The investigators have finished planning of this phase and
have received the ethics approval to start recruiting.
4. Knowledge translation: Data analysis, reporting and dissemination (months M30-M36)
E) Research Method (Only Phase 3 is included): The study will have a randomized cross-over
design with an early and a late intervention group. A maximum of 20 stroke survivors will be
divided into a late intervention and an early intervention group (10 in each group, randomly
assigned), and a maximum of 20 teens with hemiplegia will be divided into a late
intervention and an early intervention group (10 in each group, randomly assigned). The
procedures for late intervention groups are the same. Similarly, the procedures for the
early intervention groups are the same. Note that this study is asking the same research
question for two different clinical populations.
Each intervention group will be involved in the study for 6 months. Both groups will start
with a baseline assessment of outcome measures in week 1. The early intervention group will
receive the FEATHERS intervention in weeks 1-8. There will be another round of outcome
measure assessments at the end of week 8 (assessing motor recovery). There will be a period
of no intervention between weeks 9-16, followed by another round of outcome measure
assessments (assessing retention). Finally, weeks 17-24 will also be a no intervention
period, followed by another round of outcome measure assessments (assessing variation of the
outcomes even without a therapy intervention). The late intervention group will receive 2
months of no intervention followed by a round of outcome measure assessments (assessing
variation of the outcomes even without a therapy intervention). Then they will receive the
FEATHERS intervention in weeks 9-16. There will be another round of outcome measure
assessments at the end of week 16 (assessing motor recovery). Weeks 17-24 will be another
period of no intervention followed by another round of outcome measure assessments
(assessing retention).
Primary Outcome (functional outcomes) and secondary outcomes (participation outcomes) of
this study are as follows:
i.Primary Outcome: Wolf Motor Function Test WMFT (this is the test for which the
investigators conducted the a priori power calculation; it is expected to have ~80% chance
of detecting an effect with given this sample size).
ii.Secondary Outcomes:
1. Body Structure/Function: Motricity index; grip/pinch strength; NIH stroke scale;
modified rankin test; reach performance scale.
2. Activity/Participation: Canadian occupational performance measure; confidence scale;
paediatric motivation scale, usability of the system.
More details on the measures are provided under "Outcome Measures".
F) Statistical Analysis:
Phase 3: Based on previous research, the investigators estimate a standardized effect size
of 0.60 to 0.80 improvement (Cohen's d) from baseline to terminal assessment on the WMFT. By
recruiting 20 stroke subjects and 20 CP subjects, it is expected to have a statistical power
(1-β error probability) of approximately 80% for the within-subject change. Our principal
statistical test is thus the within-subject t-test comparing pre-intervention WMFT scores to
terminal WMFT test scores, combining data from both the early and the late intervention
group. In addition to this a priori comparison, WMFT test scores will be analyzed in a Group
(early versus delayed intervention) by Time (Weeks 0-8, 9-16, and 17-24) mixed-factorial
ANOVA. Secondary outcomes will include motion log files, scoring from the games themselves,
functional outcome measures, discussions with participants and exit surveys. Secondary
outcomes of function/structure and activity/participation will be analyzed using the same
Group by Time mixed-factorial ANOVA. Exploratory comparisons can also be undertaken. For
instance, the investigators data analysis will allow us to compare the motor learning
between younger and older persons with hemiplegia and the effect of the social media
framework on motivation using both quantitative and qualitative metrics (between-subjects
t-tests on the functional outcomes and motivation surveys). The investigators will be
investigating whether there is a statistical correlation between subjective measures of
motivation and the observed changes in functional outcomes.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Recruiting |
NCT03869138 -
Alternative Therapies for Improving Physical Function in Individuals With Stroke
|
N/A | |
Completed |
NCT04034069 -
Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial
|
N/A | |
Completed |
NCT04101695 -
Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects
|
N/A | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Completed |
NCT00391378 -
Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)
|
N/A | |
Recruiting |
NCT06204744 -
Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial
|
N/A | |
Active, not recruiting |
NCT06043167 -
Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
|
||
Active, not recruiting |
NCT04535479 -
Dry Needling for Spasticity in Stroke
|
N/A | |
Completed |
NCT03985761 -
Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke
|
N/A | |
Recruiting |
NCT00859885 -
International PFO Consortium
|
N/A | |
Recruiting |
NCT06034119 -
Effects of Voluntary Adjustments During Walking in Participants Post-stroke
|
N/A | |
Completed |
NCT03622411 -
Tablet-based Aphasia Therapy in the Chronic Phase
|
N/A | |
Completed |
NCT01662960 -
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
|
N/A | |
Recruiting |
NCT05854485 -
Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke
|
N/A | |
Active, not recruiting |
NCT05520528 -
Impact of Group Participation on Adults With Aphasia
|
N/A | |
Completed |
NCT03366129 -
Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
|
||
Completed |
NCT05805748 -
Serious Game Therapy in Neglect Patients
|
N/A | |
Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
Recruiting |
NCT05993221 -
Deconstructing Post Stroke Hemiparesis
|