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Clinical Trials/NCT03065127
NCT03065127
Unknown
Not Applicable

Investigating Therapies for Freezing of Gait Targeting the Cognitive, Limbic, and Sensorimotor Domains

Sun Life Financial Movement Disorders Research and Rehabilitation Centre1 site in 1 country17 target enrollmentFebruary 24, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Sun Life Financial Movement Disorders Research and Rehabilitation Centre
Enrollment
17
Locations
1
Primary Endpoint
Gait Assessment
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 24, 2017
End Date
August 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Sun Life Financial Movement Disorders Research and Rehabilitation Centre
Responsible Party
Principal Investigator
Principal Investigator

Rebecca Chow

Primary Investigator

Sun Life Financial Movement Disorders Research and Rehabilitation Centre

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

Outcomes

Primary Outcomes

Gait Assessment

Time Frame: Change from Baseline at 4 weeks of third treatment phase

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.

Secondary Outcomes

  • Passive Joint Angle Matching(Pre-intervention and Post-intervention at week 4 of third treatment phase)
  • Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III)(Pre-intervention and Post-intervention at week 4 of third treatment phase)
  • New Freezing of Gait Questionnaire (NFOGQ)(Pre-intervention and Post-intervention at week 4 of third treatment phase)
  • Stroop Test(Pre-intervention and Post-intervention at week 4 of third treatment phase)
  • Trail-making test(Pre-intervention and Post-intervention at week 4 of third treatment phase)
  • Parkinson Anxiety Scale(Pre-intervention and Post-intervention at week 4 of third treatment phase)

Study Sites (1)

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