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Investigating Therapies for Freezing of Gait

Primary Purpose

Parkinson Disease, Gait Disorders, Neurologic

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive Training
Cognitive Behavioural Therapy
Proprioceptive Training
Sponsored by
Sun Life Financial Movement Disorders Research and Rehabilitation Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sun Life Financial Movement Disorders Research and Rehabilitation Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cognitive Training

Cognitive Behavioural Therapy

Proprioceptive Training

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Stroop Test
This test assesses inhibitory control and will be administered in a paper-based format.
Trail-making test
This will also be administered in a paper-based format. This test will assess visuospatial function and set-shifting ability.
Stroop Test
This test assesses inhibitory control and will be administered in a paper-based format.
Trail-making test
This will also be administered in a paper-based format. This test will assess visuospatial function and set-shifting ability.
Stroop Test
This test assesses inhibitory control and will be administered in a paper-based format.
Trail-making test
This will also be administered in a paper-based format. This test will assess visuospatial function and set-shifting ability.
Passive Joint Angle Matching
This task will be assessed in order to evaluate proprioceptive functioning.
Passive Joint Angle Matching
This task will be assessed in order to evaluate proprioceptive functioning.
Passive Joint Angle Matching
This task will be assessed in order to evaluate proprioceptive functioning.
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).
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).
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).
Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III)
A clinician administered assessment which evaluates individuals' motor symptom severity
Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III)
A clinician administered assessment which evaluates individuals' motor symptom severity
Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III)
A clinician administered assessment which evaluates individuals' motor symptom severity
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.
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.
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.

Full Information

First Posted
February 9, 2017
Last Updated
April 24, 2017
Sponsor
Sun Life Financial Movement Disorders Research and Rehabilitation Centre
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1. Study Identification

Unique Protocol Identification Number
NCT03065127
Brief Title
Investigating Therapies for Freezing of Gait
Official Title
Investigating Therapies for Freezing of Gait Targeting the Cognitive, Limbic, and Sensorimotor Domains
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 24, 2017 (Actual)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Life Financial Movement Disorders Research and Rehabilitation Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Gait Disorders, Neurologic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Cognitive Behavioural Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Proprioceptive Training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioural Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Proprioceptive Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gait Assessment
Description
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
Title
Gait Assessment
Description
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
Title
Gait Assessment
Description
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
Secondary Outcome Measure Information:
Title
Stroop Test
Description
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
Title
Trail-making test
Description
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
Title
Stroop Test
Description
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
Title
Trail-making test
Description
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
Title
Stroop Test
Description
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
Title
Trail-making test
Description
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
Title
Passive Joint Angle Matching
Description
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
Title
Passive Joint Angle Matching
Description
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
Title
Passive Joint Angle Matching
Description
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
Title
Parkinson Anxiety Scale
Description
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
Title
Parkinson Anxiety Scale
Description
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
Title
Parkinson Anxiety Scale
Description
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
Title
Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III)
Description
A clinician administered assessment which evaluates individuals' motor symptom severity
Time Frame
Pre-intervention and Post-intervention at week 4 of first treatment phase
Title
Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III)
Description
A clinician administered assessment which evaluates individuals' motor symptom severity
Time Frame
Pre-intervention and Post-intervention at week 4 of second treatment phase
Title
Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III)
Description
A clinician administered assessment which evaluates individuals' motor symptom severity
Time Frame
Pre-intervention and Post-intervention at week 4 of third treatment phase
Title
New Freezing of Gait Questionnaire (NFOGQ)
Description
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
Title
New Freezing of Gait Questionnaire (NFOGQ)
Description
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
Title
New Freezing of Gait Questionnaire (NFOGQ)
Description
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Chow, BSc
Organizational Affiliation
Sun Life Financial Movement Disorders Research and Rehabilitation Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Life Financial Movement Disorders Research and Rehabilitation Centre
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3C5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33559531
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.
Results Reference
derived

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Investigating Therapies for Freezing of Gait

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