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Provocation of Freezing of Gait in Parkinson's Disease

Primary Purpose

Parkinson Disease, Freezing of Gait

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
walking speed
visual loading
dual task
best side reduction
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Parkinson Disease focused on measuring Parkinson, freezing, spilt-belt, Dual task, visual

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Idiopathic Parkinson's disease
  • Hoehn & Yahr Stage 1-3
  • Ten with self-reported freezing of gait (score of 1 in part 1 of new freezing of gait questionnaire), and 10 without FOG..
  • Sequence effect on feet (as score of at least 2 in the leg agility (item#3.8) of Movement Disorders Society-Unified Parkinson's disease rating scale part 3)
  • Stable clinical response to medications or stimulation parameters for at least 1 months
  • Able to walk on a motor-driven treadmill
  • Ability to provide informed consent

Exclusion Criteria:

  • Severe imbalance that limits ambulation (Hoehn &Yahr score above 4)
  • Orthostatic hypotension
  • Orthopedic conditions and other systemic disease affecting locomotion
  • Shortness of breath and cardiac disease
  • Psychiatric disorders needing medication
  • Dementia
  • Presence of other neurological disorder

Sites / Locations

  • Toronto Western Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Natural walking

fast walking

normal walking passing through narrow pathway

fast walking passing through narrow pathway

Natural walking with dual task

fast walking with dual task

Natural walking passing through narrow pathway and during cognitive dual task

fast walking passing through narrow pathway and during cognitive dual task

Natural walking reducing the best side

fast walking reducing the best side

Natural walking reducing the best side passing through narrow pathway

fast walking reducing the best side passing through narrow pathway

Natural walking reducing the best side with cognitive dual task

fast walking reducing the best side with cognitive dual task

Natural walking reducing the best side passing through narrow pathway and during cognitive dual task

fast walking reducing the best side passing through narrow pathway and during cognitive dual task

Arm Description

Outcomes

Primary Outcome Measures

number of freezing of gait
provoked freezing of gait during each situation

Secondary Outcome Measures

Correlation with Montreal cognitive assessment, Movement Disorders Society-unified Parkinson's disease rating scale part 2 and 3, Activities-Specific Balance Confidence Scale, Parkinson's disease questionnaire-39, and New freezing of gait questionnaire
Correlation of detected number of freezing of gait with clinical scales
Comparison of number/duration of provoked freezing of gait among the situations between Parkinson's disease patients with and without freezing of gait
Comparison between two groups

Full Information

First Posted
March 11, 2021
Last Updated
March 11, 2021
Sponsor
University of Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT04799613
Brief Title
Provocation of Freezing of Gait in Parkinson's Disease
Official Title
Experimentally-induced Freezing of Gait in Parkinson's Disease by Modulating Step Length/Asymmetry and Cognitive/Visual Loading
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 15, 2021 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto

4. Oversight

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

5. Study Description

Brief Summary
Sample Size N= 10 Parkinson's disease patients with self-reported freezing of gait and 10 without self-reported freezing of gait (in total, 20 Parkinson's disease patients) Accrual Period Single visit for 2 hours Study Design This is a cross-sectional study with an intervention to provoke freezing of gait using split-belt treadmill in Parkinson's disease patients with a randomized cross-over design. After baseline evaluation (a), interventions to induce freezing of gait will be performed in a randomized order to avoid a practice/fatigue effect in the following conditions using combination of 4 interventions: walking speed (fast walking vs. natural walking), visual loading (passing through narrow pathway), cognitive loading (dual task), and asymmetry (best side reduction). Natural and fast walking with self-paced mode to access gait parameters and decide the speed for evaluation (3 mins X2) remaining assessment will be randomized and performed on the treadmill: Natural and fast walking passing through narrow pathway (2 mins X2) Natural and fast walking with dual task (2 mins X2) Natural and fast walking passing through narrow pathway and during cognitive dual task (2 mins X2) Natural and fast walking reducing the best side (2 mins X2) Natural and fast walking reducing the best side passing through narrow pathway (2 mins X2) Natural and fast walking reducing the best side with cognitive dual task (2 mins X2) Natural and fast walking reducing the best side passing through narrow pathway and during cognitive dual task (2 mins X2) Conditions b-h will be carried out on a split-belt treadmill (Grail systems®, by Motek, Netherlands). (b-i) freezing of gait episodes will be identified with synchronized videorecordings (screening done by two independent observers). Episodes identified by both observers will be confirmed and measured by comparing the relative height of metatarsal and heel markers of each foot, in keeping with a previous study evaluating freezing of gait episode on a treadmill. Study Duration (Baselines evaluation) Enrolment and assessment (Montreal cognitive assessment, Movement Disorders Society-unified Parkinson's disease rating scale part 2, 3 and 4, Activities-Specific Balance Confidence Scale, Parkinson's disease questionnaire-39, and New freezing of gait questionnaire) (a) Formal gait analysis using split-belt treadmill (Grail systems®, by Motek, Netherlands) will be done for baseline assessment (normal walking) and to test patient's ability for fast walking (25% of the normal speed). (b-h) Provocation of freezing of gait at split-belt treadmill (Grail systems®, by Motek, Netherlands) with natural and fast walking with/without additional loading or interventions on the asymmetry Total time= 2 hours Study Intervention Freezing of gait will be provoked based on the situations combined among 4 conditions; (1) interventions on asymmetry, (2) cognitive dual task, (3) visual loading - passing through narrow pathway, and (4) walking speed at a split-belt treadmill. Fast walking will be defined as walking 25% faster than the normal comfortable walking. Subjects who cannot reach this speed, will be asked to walk at their safest maximum speed. Passing narrow pathway will be done by walking in a "rope bridge" scene in virtual reality (VR). Dual cognitive task will be carried out with serial subtraction prompted on the screen in VR. Best side reduction will be defined as 25% slower speed on the best side based on the speed during the initial natural walking with tied configuration setting based on a previous study.3 Condition b-h will be randomized.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Freezing of Gait
Keywords
Parkinson, freezing, spilt-belt, Dual task, visual

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Natural walking
Arm Type
No Intervention
Arm Title
fast walking
Arm Type
Experimental
Arm Title
normal walking passing through narrow pathway
Arm Type
Experimental
Arm Title
fast walking passing through narrow pathway
Arm Type
Experimental
Arm Title
Natural walking with dual task
Arm Type
Experimental
Arm Title
fast walking with dual task
Arm Type
Experimental
Arm Title
Natural walking passing through narrow pathway and during cognitive dual task
Arm Type
Experimental
Arm Title
fast walking passing through narrow pathway and during cognitive dual task
Arm Type
Experimental
Arm Title
Natural walking reducing the best side
Arm Type
Experimental
Arm Title
fast walking reducing the best side
Arm Type
Experimental
Arm Title
Natural walking reducing the best side passing through narrow pathway
Arm Type
Experimental
Arm Title
fast walking reducing the best side passing through narrow pathway
Arm Type
Experimental
Arm Title
Natural walking reducing the best side with cognitive dual task
Arm Type
Experimental
Arm Title
fast walking reducing the best side with cognitive dual task
Arm Type
Experimental
Arm Title
Natural walking reducing the best side passing through narrow pathway and during cognitive dual task
Arm Type
Experimental
Arm Title
fast walking reducing the best side passing through narrow pathway and during cognitive dual task
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
walking speed
Intervention Description
walking speed (normal speed vs. fast speed). fast speed was 25% faster than normal speed
Intervention Type
Other
Intervention Name(s)
visual loading
Intervention Description
visual loading (walking through narrow pathway using VR)
Intervention Type
Other
Intervention Name(s)
dual task
Intervention Description
dual task (serial subtraction using VR)
Intervention Type
Other
Intervention Name(s)
best side reduction
Intervention Description
best side reduction (split belt mode, the speed of best side was reduced by 25% compared to the other side)
Primary Outcome Measure Information:
Title
number of freezing of gait
Description
provoked freezing of gait during each situation
Time Frame
Within intervention (2mins for each situation)
Secondary Outcome Measure Information:
Title
Correlation with Montreal cognitive assessment, Movement Disorders Society-unified Parkinson's disease rating scale part 2 and 3, Activities-Specific Balance Confidence Scale, Parkinson's disease questionnaire-39, and New freezing of gait questionnaire
Description
Correlation of detected number of freezing of gait with clinical scales
Time Frame
Within intervention (2mins for each situation)
Title
Comparison of number/duration of provoked freezing of gait among the situations between Parkinson's disease patients with and without freezing of gait
Description
Comparison between two groups
Time Frame
Within intervention (2mins for each situation)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Idiopathic Parkinson's disease Hoehn & Yahr Stage 1-3 Ten with self-reported freezing of gait (score of 1 in part 1 of new freezing of gait questionnaire), and 10 without FOG.. Sequence effect on feet (as score of at least 2 in the leg agility (item#3.8) of Movement Disorders Society-Unified Parkinson's disease rating scale part 3) Stable clinical response to medications or stimulation parameters for at least 1 months Able to walk on a motor-driven treadmill Ability to provide informed consent Exclusion Criteria: Severe imbalance that limits ambulation (Hoehn &Yahr score above 4) Orthostatic hypotension Orthopedic conditions and other systemic disease affecting locomotion Shortness of breath and cardiac disease Psychiatric disorders needing medication Dementia Presence of other neurological disorder
Facility Information:
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
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Provocation of Freezing of Gait in Parkinson's Disease

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