Investigating Therapies for Freezing of Gait

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03065127
• Other study ID #: SunLife
• Status: Active, not recruiting
• Phase: N/A
• First received: February 9, 2017
• Last updated: April 24, 2017
• Start date: February 24, 2017
• Est. completion date: August 2017

Study information

• Verified date: April 2017
• Source: Sun Life Financial Movement Disorders Research and Rehabilitation Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 17
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Nervous System Diseases
• Parkinson Disease

Intervention

Behavioral:
• Cognitive 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.
• Cognitive Behavioural Therapy
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.
• Proprioceptive Training
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.

Locations

Country	Name	City	State
Canada	Sun Life Financial Movement Disorders Research and Rehabilitation Centre	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sun Life Financial Movement Disorders Research and Rehabilitation Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Stroop Test	This test assesses inhibitory control and will be administered in a paper-based format.	Pre-intervention and Post-intervention at week 4 of first treatment phase
Secondary	Trail-making test	This will also be administered in a paper-based format. This test will assess visuospatial function and set-shifting ability.	Pre-intervention and Post-intervention at week 4 of first treatment phase
Secondary	Stroop Test	This test assesses inhibitory control and will be administered in a paper-based format.	Pre-intervention and Post-intervention at week 4 of second treatment phase
Secondary	Trail-making test	This will also be administered in a paper-based format. This test will assess visuospatial function and set-shifting ability.	Pre-intervention and Post-intervention at week 4 of second treatment phase
Secondary	Stroop Test	This test assesses inhibitory control and will be administered in a paper-based format.	Pre-intervention and Post-intervention at week 4 of third treatment phase
Secondary	Trail-making test	This will also be administered in a paper-based format. This test will assess visuospatial function and set-shifting ability.	Pre-intervention and Post-intervention at week 4 of third treatment phase
Secondary	Passive Joint Angle Matching	This task will be assessed in order to evaluate proprioceptive functioning.	Pre-intervention and Post-intervention at week 4 of first treatment phase
Secondary	Passive Joint Angle Matching	This task will be assessed in order to evaluate proprioceptive functioning.	Pre-intervention and Post-intervention at week 4 of second treatment phase
Secondary	Passive Joint Angle Matching	This task will be assessed in order to evaluate proprioceptive functioning.	Pre-intervention and Post-intervention at week 4 of third treatment phase
Secondary	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).	Pre-intervention and Post-intervention at week 4 of first treatment phase
Secondary	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).	Pre-intervention and Post-intervention at week 4 of second treatment phase
Secondary	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).	Pre-intervention and Post-intervention at week 4 of third treatment phase
Secondary	Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III)	A clinician administered assessment which evaluates individuals' motor symptom severity	Pre-intervention and Post-intervention at week 4 of first treatment phase
Secondary	Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III)	A clinician administered assessment which evaluates individuals' motor symptom severity	Pre-intervention and Post-intervention at week 4 of second treatment phase
Secondary	Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III)	A clinician administered assessment which evaluates individuals' motor symptom severity	Pre-intervention and Post-intervention at week 4 of third treatment phase
Secondary	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.	Pre-intervention and Post-intervention at week 4 of first treatment phase
Secondary	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.	Pre-intervention and Post-intervention at week 4 of second treatment phase
Secondary	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.	Pre-intervention and Post-intervention at week 4 of third treatment phase