Investigating Therapies for Freezing of Gait
1 other identifier
interventional
17
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable parkinson-disease
Started Feb 2017
Shorter than P25 for not_applicable parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2017
CompletedStudy Start
First participant enrolled
February 24, 2017
CompletedFirst Posted
Study publicly available on registry
February 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedApril 25, 2017
April 1, 2017
5 months
February 9, 2017
April 24, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
Change from Baseline at 4 weeks of third treatment phase
Secondary Outcomes (18)
Stroop Test
Pre-intervention and Post-intervention at week 4 of first treatment phase
Trail-making test
Pre-intervention and Post-intervention at week 4 of first treatment phase
Stroop Test
Pre-intervention and Post-intervention at week 4 of second treatment phase
Trail-making test
Pre-intervention and Post-intervention at week 4 of second treatment phase
Stroop Test
Pre-intervention and Post-intervention at week 4 of third treatment phase
- +13 more secondary outcomes
Study Arms (3)
Cognitive Training
EXPERIMENTALParticipants 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.
Cognitive Behavioural Therapy
EXPERIMENTALParticipants 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.
Proprioceptive Training
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Either gender
- Diagnosed with idiopathic PD by a Neurologist
- Self-reported FOG with the use of UPDRS-II (Question 14)
- Confirmation of present FOG by a movement disorder specialist
- Able to walk 10 meters, unassisted
- Able to understand English instructions
You may not qualify if:
- A neurological disease other than PD
- Peripheral neuropathy
- Clinically diagnosed with dementia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sun Life Financial Movement Disorders Research and Rehabilitation Centre
Waterloo, Ontario, N2L 3C5, Canada
Related Publications (1)
Chow R, Tripp BP, Rzondzinski D, Almeida QJ. Investigating Therapies for Freezing of Gait Targeting the Cognitive, Limbic, and Sensorimotor Domains. Neurorehabil Neural Repair. 2021 Mar;35(3):290-299. doi: 10.1177/1545968321992331. Epub 2021 Feb 9.
PMID: 33559531DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rebecca Chow, BSc
Sun Life Financial Movement Disorders Research and Rehabilitation Centre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Primary Investigator
Study Record Dates
First Submitted
February 9, 2017
First Posted
February 27, 2017
Study Start
February 24, 2017
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
April 25, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share