An interventional study of Cognitive Training and Cognitive Behavioural Therapy in Parkinson Disease and Gait Disorders, Neurologic, sponsored by Sun Life Financial Movement Disorders Research and Rehabilitation Centre. Status unknown at 1 site in Canada. Per ClinicalTrials.gov, last updated 2017-04-25.
Sponsored by Sun Life Financial Movement Disorders Research and Rehabilitation Centre · Not applicable, Interventional, and Treatment
Among 10 studies in Parkinson Disease by Sun Life Financial Movement Disorders Research and Rehabilitation Centre — none open to participants now, none under way, none of them phase 3. Parkinson Disease · Sun Life Financial Movement Disorders Research and Rehabilitation Centre.
Among the 10 studies in Parkinson Disease by Sun Life Financial Movement Disorders Research and Rehabilitation Centre, this one is the 10th largest by enrollment, is the only one that started in 2017, is one of 10 with no phase, and was the 6th registered.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
Browse Parkinson Disease studies →None of the 10 studies in Parkinson Disease by Sun Life Financial Movement Disorders Research and Rehabilitation Centre is open now.
Of the 748 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 63 take children under 18; 189 take healthy volunteers.
This study: all sexes · no healthy volunteers.
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10 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 1 started in 2017.
This study's enrollment of 17 is below the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Median enrollment 57 across the 10 interventional studies. Of the 2 that completed or were terminated, 0 (0%) have results posted.
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Sun Life Financial Movement Disorders Research and Rehabilitation Centre is the lead sponsor of 10 studies on the registry; none are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Parkinson Disease by Sun Life Financial Movement Disorders Research and Rehabilitation Centre, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Freezing of gait (FOG) is arguably one of the most debilitating motor symptoms experienced by individuals with Parkinson's disease (PD). FOG may be caused by an overload of cognitive, limbic, and sensorimotor system activity in the basal ganglia. Therefore, the purpose of this study is to evaluate cognitive, limbic, and sensorimotor therapies in individuals with FOG. Participants in this study will undergo all three types of treatments in a randomized counterbalanced order. Each treatment will occur in 1 hour sessions, twice weekly for a period of 4 weeks.
Freezing of gait (FOG) is arguably one of the most debilitating motor symptoms experienced by individuals with Parkinson's disease (PD), and negatively impacts quality of life (Walton et al., 2015). Furthermore, advanced FOG does not respond well to treatments commonly used in Parkinson's disease (Nutt et al., 2011), therefore warranting the use of adjunct treatment options. The development of potential treatment strategies for FOG should focus on the underlying mechanism. The cross-talk model of FOG proposes that FOG may be caused by an overload of cognitive, limbic, and sensorimotor system activity in the basal ganglia, resulting in a depletion of dopaminergic resources, leading to FOG (Lewis \& Barker, 2009). Hence, based on the cross-talk model, treatments targeting the cognitive, sensorimotor and limbic systems independently may lead to a reduction in FOG episodes. Previous studies have demonstrated the efficacy of therapies targeting these domains in PD and healthy individuals, however, these have yet to be explored in FOG. Therefore, the purpose of this study is to evaluate cognitive, sensorimotor, and limbic therapies in individuals with FOG.
This study will employ a within-subjects design, in which participants will undergo all three treatments in a randomized counterbalanced order. Sessions for each type of treatment will occur for 1 hour, twice weekly for a period of 4 weeks. Participants will also undergo pre- and post-test assessments prior to and following each 4-week treatment period. The cognitive training will utilize the "Smartbrain Pro" computer software, which has previously demonstrated efficacy in individuals with Parkinson's disease (Paris et al., 2011). The sensorimotor training group will participate in proprioceptive training of the upper and lower limbs. This training will entail a target matching task, in which participants will produce active and self-defined movements while blindfolded (i.e. without visual feedback). The limbic training group will undergo cognitive behavioural therapy (CBT) focusing solely on anxiety symptoms.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants will independently complete cognitive exercises on the "Smartbrain Pro" computer software. These exercises aim to train different aspects of executive function. The difficulty level of each exercise will increase relative to each participant's progress. Sessions will last for one hour, occurring twice weekly for a period of 4 weeks.
Behavioral: Cognitive Training
Participants will undergo one-on-one sessions of cognitive-behavioural therapy (CBT) working with a therapist to establish an individualized CBT plan which will focus on symptoms of anxiety. Participants will complete a total of eight one-hour sessions over 4 weeks.
Behavioral: Cognitive Behavioural Therapy
Participants will complete one-on-one sessions a target matching proprioceptive training protocol using their upper and lower limbs. For the upper limb target-reaching task, participants will be seated in front of a surface marked with ten targets. They will first visualize a specified target, then blindfolded and asked to reach towards that target with the blindfold on. The blindfold will then be removed allowing participants to view their performance relative to the target. This task will be repeated for the remaining targets on both sides and for both upper and lower limbs. Participants will complete a total of eight one-hour sessions over 4 weeks.
Behavioral: Proprioceptive Training
Training the cognitive domain may be accomplished by training various cognitive and executive functions with guided practice focusing on specific skills (e.g. visuospatial processing, executive function, memory, language, and attention). Cognitive training has been demonstrated to be efficacious in several studies in individuals with PD. Given the potential cognitive contribution to FOG episodes, this type of therapy may alleviate FOG by potentially improving upon planning, set-shifting, and/or response inhibition.
CBT has been demonstrated to be effective in the remediation of anxiety in individuals with PD. This may be beneficial to individuals experiencing FOG, given the evidence that anxiety may provoke FOG. During periods of elevated anxiety (e.g. walking in a threatening environment), freezers will be able to more efficiently process this limbic load resulting in greater resources available for movement control.
Currently, studies investigating proprioceptive training as a treatment in PD are limited. However, this type of training has potential by improving proprioceptive processing. It would be expected that due to this training, when sensorimotor processing is challenged during locomotion (e.g. by removing visual feedback and preventing compensation of proprioception deficits), freezers would experience less decrements to gait due to an enhanced ability to process sensorimotor demands.
Gait Assessment
Participants will walk approximately 9.75 metres for 12 trials. Recording of kinematic data will be done with eight Optotrak® cameras (Northern Digital, NDI, Waterloo, Ontario). Spatiotemporal gait parameters will be analyzed from this assessment.
Time frame: Change from Baseline at 4 weeks of first treatment phase
Gait Assessment
Participants will walk approximately 9.75 metres for 12 trials. Recording of kinematic data will be done with eight Optotrak® cameras (Northern Digital, NDI, Waterloo, Ontario). Spatiotemporal gait parameters will be analyzed from this assessment.
Time frame: Change from Baseline at 4 weeks of second treatment phase
Gait Assessment
Participants will walk approximately 9.75 metres for 12 trials. Recording of kinematic data will be done with eight Optotrak® cameras (Northern Digital, NDI, Waterloo, Ontario). Spatiotemporal gait parameters will be analyzed from this assessment.
Time frame: Change from Baseline at 4 weeks of third treatment phase
Stroop Test
This test assesses inhibitory control and will be administered in a paper-based format.
Time frame: Pre-intervention and Post-intervention at week 4 of first treatment phase
Trail-making test
This will also be administered in a paper-based format. This test will assess visuospatial function and set-shifting ability.
Time frame: Pre-intervention and Post-intervention at week 4 of first treatment phase
Stroop Test
This test assesses inhibitory control and will be administered in a paper-based format.
Time frame: Pre-intervention and Post-intervention at week 4 of second treatment phase
Trail-making test
This will also be administered in a paper-based format. This test will assess visuospatial function and set-shifting ability.
Time frame: Pre-intervention and Post-intervention at week 4 of second treatment phase
Stroop Test
This test assesses inhibitory control and will be administered in a paper-based format.
Time frame: Pre-intervention and Post-intervention at week 4 of third treatment phase
Trail-making test
This will also be administered in a paper-based format. This test will assess visuospatial function and set-shifting ability.
Time frame: Pre-intervention and Post-intervention at week 4 of third treatment phase
Passive Joint Angle Matching
This task will be assessed in order to evaluate proprioceptive functioning.
Time frame: Pre-intervention and Post-intervention at week 4 of first treatment phase
Passive Joint Angle Matching
This task will be assessed in order to evaluate proprioceptive functioning.
Time frame: Pre-intervention and Post-intervention at week 4 of second treatment phase
Passive Joint Angle Matching
This task will be assessed in order to evaluate proprioceptive functioning.
Time frame: Pre-intervention and Post-intervention at week 4 of third treatment phase
Parkinson Anxiety Scale
The Parkinson Anxiety Scale (PAS), which is a self-report questionnaire used to assess anxiety levels, will be administered to participants. This tool has demonstrated good concurrent validity in individuals with PD against other existing anxiety scales (Leentjens et al., 2014).
Time frame: Pre-intervention and Post-intervention at week 4 of first treatment phase
Parkinson Anxiety Scale
The Parkinson Anxiety Scale (PAS), which is a self-report questionnaire used to assess anxiety levels, will be administered to participants. This tool has demonstrated good concurrent validity in individuals with PD against other existing anxiety scales (Leentjens et al., 2014).
Time frame: Pre-intervention and Post-intervention at week 4 of second treatment phase
Parkinson Anxiety Scale
The Parkinson Anxiety Scale (PAS), which is a self-report questionnaire used to assess anxiety levels, will be administered to participants. This tool has demonstrated good concurrent validity in individuals with PD against other existing anxiety scales (Leentjens et al., 2014).
Time frame: Pre-intervention and Post-intervention at week 4 of third treatment phase
Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III)
A clinician administered assessment which evaluates individuals' motor symptom severity
Time frame: Pre-intervention and Post-intervention at week 4 of first treatment phase
Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III)
A clinician administered assessment which evaluates individuals' motor symptom severity
Time frame: Pre-intervention and Post-intervention at week 4 of second treatment phase
Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III)
A clinician administered assessment which evaluates individuals' motor symptom severity
Time frame: Pre-intervention and Post-intervention at week 4 of third treatment phase
New Freezing of Gait Questionnaire (NFOGQ)
Participants will be asked to complete the New Freezing of Gait Questionnaire (NFOGQ) questionnaire developed by Nieuwboer and colleagues (2009). This provides a self-reported measure of frequency and duration of FOG episodes. This tool has been validated and proven to be highly reliable in individuals with PD, as well as assessing treatment interventions for FOG.
Time frame: Pre-intervention and Post-intervention at week 4 of first treatment phase
New Freezing of Gait Questionnaire (NFOGQ)
Participants will be asked to complete the New Freezing of Gait Questionnaire (NFOGQ) questionnaire developed by Nieuwboer and colleagues (2009). This provides a self-reported measure of frequency and duration of FOG episodes. This tool has been validated and proven to be highly reliable in individuals with PD, as well as assessing treatment interventions for FOG.
Time frame: Pre-intervention and Post-intervention at week 4 of second treatment phase
New Freezing of Gait Questionnaire (NFOGQ)
Participants will be asked to complete the New Freezing of Gait Questionnaire (NFOGQ) questionnaire developed by Nieuwboer and colleagues (2009). This provides a self-reported measure of frequency and duration of FOG episodes. This tool has been validated and proven to be highly reliable in individuals with PD, as well as assessing treatment interventions for FOG.
Time frame: Pre-intervention and Post-intervention at week 4 of third treatment phase
Plan to share: No
Started Feb 2017 (actual). Primary completion is estimated for Aug 2017, 6 months after the start.
Of 1,291 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 6 months is below that.
Counting every sponsor, half of 1,367 studies reached it within 25 months; a quarter within 11 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Sun Life Financial Movement Disorders Research and Rehabilitation Centre