Clinical trial NCT03065127: Investigating Therapies for Freezing of Gait
Official title: Investigating Therapies for Freezing of Gait Targeting the Cognitive, Limbic, and Sensorimotor Domains
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Gait Disorders, Neurologic
Lead sponsor: Sun Life Financial Movement Disorders Research and Rehabilitation Centre
Sponsor class: OTHER
First posted: 2017-02-27
Enrollment: 17
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* A neurological disease other than PD
* Peripheral neuropathy
* Clinically diagnosed with dementia

Primary outcomes:
measure: Gait Assessment
timeFrame: Change from Baseline at 4 weeks of first treatment phase
measure: Gait Assessment
timeFrame: Change from Baseline at 4 weeks of second treatment phase
measure: Gait Assessment
timeFrame: Change from Baseline at 4 weeks of third treatment phase
Secondary outcomes:
measure: Stroop Test
timeFrame: Pre-intervention and Post-intervention at week 4 of first treatment phase
measure: Trail-making test
timeFrame: Pre-intervention and Post-intervention at week 4 of first treatment phase
measure: Stroop Test
timeFrame: Pre-intervention and Post-intervention at week 4 of second treatment phase
measure: Trail-making test
timeFrame: Pre-intervention and Post-intervention at week 4 of second treatment phase
measure: Stroop Test
timeFrame: Pre-intervention and Post-intervention at week 4 of third treatment phase
measure: Trail-making test
timeFrame: Pre-intervention and Post-intervention at week 4 of third treatment phase
measure: Passive Joint Angle Matching
timeFrame: Pre-intervention and Post-intervention at week 4 of first treatment phase
measure: Passive Joint Angle Matching
timeFrame: Pre-intervention and Post-intervention at week 4 of second treatment phase
measure: Passive Joint Angle Matching
timeFrame: Pre-intervention and Post-intervention at week 4 of third treatment phase
measure: Parkinson Anxiety Scale
timeFrame: Pre-intervention and Post-intervention at week 4 of first treatment phase
measure: Parkinson Anxiety Scale
timeFrame: Pre-intervention and Post-intervention at week 4 of second treatment phase
measure: Parkinson Anxiety Scale
timeFrame: Pre-intervention and Post-intervention at week 4 of third treatment phase
measure: Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III)
timeFrame: Pre-intervention and Post-intervention at week 4 of first treatment phase
measure: Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III)
timeFrame: Pre-intervention and Post-intervention at week 4 of second treatment phase
measure: Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III)
timeFrame: Pre-intervention and Post-intervention at week 4 of third treatment phase
measure: New Freezing of Gait Questionnaire (NFOGQ)
timeFrame: Pre-intervention and Post-intervention at week 4 of first treatment phase
measure: New Freezing of Gait Questionnaire (NFOGQ)
timeFrame: Pre-intervention and Post-intervention at week 4 of second treatment phase
measure: New Freezing of Gait Questionnaire (NFOGQ)
timeFrame: Pre-intervention and Post-intervention at week 4 of third treatment phase
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Sun Life Financial Movement Disorders Research and Rehabilitation Centre
state: Ontario
Study officials:
affiliation: Sun Life Financial Movement Disorders Research and Rehabilitation Centre
name: Rebecca Chow, BSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.