Provocation of Freezing of Gait in Parkinson's Disease

March 11, 2021 updated by: Alfonso Fasano, University of Toronto

Experimentally-induced Freezing of Gait in Parkinson's Disease by Modulating Step Length/Asymmetry and Cognitive/Visual Loading

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).

  1. 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:
  2. Natural and fast walking passing through narrow pathway (2 mins X2)
  3. Natural and fast walking with dual task (2 mins X2)
  4. Natural and fast walking passing through narrow pathway and during cognitive dual task (2 mins X2)
  5. Natural and fast walking reducing the best side (2 mins X2)
  6. Natural and fast walking reducing the best side passing through narrow pathway (2 mins X2)
  7. Natural and fast walking reducing the best side with cognitive dual task (2 mins X2)

  8. 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

  1. (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)
  2. (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).
  3. (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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Natural walking
Experimental: fast walking
Other: walking speed
walking speed (normal speed vs. fast speed). fast speed was 25% faster than normal speed
Experimental: normal walking passing through narrow pathway
Other: visual loading
visual loading (walking through narrow pathway using VR)
Experimental: fast walking passing through narrow pathway
Other: walking speed
walking speed (normal speed vs. fast speed). fast speed was 25% faster than normal speed
Other: visual loading
visual loading (walking through narrow pathway using VR)
Experimental: Natural walking with dual task
Other: dual task
dual task (serial subtraction using VR)
Experimental: fast walking with dual task
Other: walking speed
walking speed (normal speed vs. fast speed). fast speed was 25% faster than normal speed
Other: dual task
dual task (serial subtraction using VR)
Experimental: Natural walking passing through narrow pathway and during cognitive dual task
Other: visual loading
visual loading (walking through narrow pathway using VR)
Other: dual task
dual task (serial subtraction using VR)
Experimental: fast walking passing through narrow pathway and during cognitive dual task
Other: walking speed
walking speed (normal speed vs. fast speed). fast speed was 25% faster than normal speed
Other: visual loading
visual loading (walking through narrow pathway using VR)
Other: dual task
dual task (serial subtraction using VR)
Experimental: Natural walking reducing the best side
Other: best side reduction
best side reduction (split belt mode, the speed of best side was reduced by 25% compared to the other side)
Experimental: fast walking reducing the best side
Other: walking speed
walking speed (normal speed vs. fast speed). fast speed was 25% faster than normal speed
Other: best side reduction
best side reduction (split belt mode, the speed of best side was reduced by 25% compared to the other side)
Experimental: Natural walking reducing the best side passing through narrow pathway
Other: visual loading
visual loading (walking through narrow pathway using VR)
Other: best side reduction
best side reduction (split belt mode, the speed of best side was reduced by 25% compared to the other side)
Experimental: fast walking reducing the best side passing through narrow pathway
Other: walking speed
walking speed (normal speed vs. fast speed). fast speed was 25% faster than normal speed
Other: visual loading
visual loading (walking through narrow pathway using VR)
Other: best side reduction
best side reduction (split belt mode, the speed of best side was reduced by 25% compared to the other side)
Experimental: Natural walking reducing the best side with cognitive dual task
Other: dual task
dual task (serial subtraction using VR)
Other: best side reduction
best side reduction (split belt mode, the speed of best side was reduced by 25% compared to the other side)
Experimental: fast walking reducing the best side with cognitive dual task
Other: walking speed
walking speed (normal speed vs. fast speed). fast speed was 25% faster than normal speed
Other: dual task
dual task (serial subtraction using VR)
Other: best side reduction
best side reduction (split belt mode, the speed of best side was reduced by 25% compared to the other side)
Experimental: Natural walking reducing the best side passing through narrow pathway and during cognitive dual task
Other: visual loading
visual loading (walking through narrow pathway using VR)
Other: dual task
dual task (serial subtraction using VR)
Other: best side reduction
best side reduction (split belt mode, the speed of best side was reduced by 25% compared to the other side)
Experimental: fast walking reducing the best side passing through narrow pathway and during cognitive dual task
Other: walking speed
walking speed (normal speed vs. fast speed). fast speed was 25% faster than normal speed
Other: visual loading
visual loading (walking through narrow pathway using VR)
Other: dual task
dual task (serial subtraction using VR)
Other: best side reduction
best side reduction (split belt mode, the speed of best side was reduced by 25% compared to the other side)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of freezing of gait
Time Frame: Within intervention (2mins for each situation)
provoked freezing of gait during each situation
Within intervention (2mins for each situation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Within intervention (2mins for each situation)
Correlation of detected number of freezing of gait with clinical scales
Within intervention (2mins for each situation)
Comparison of number/duration of provoked freezing of gait among the situations between Parkinson's disease patients with and without freezing of gait
Time Frame: Within intervention (2mins for each situation)
Comparison between two groups
Within intervention (2mins for each situation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 15, 2021

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

March 11, 2021

First Submitted That Met QC Criteria

March 11, 2021

First Posted (Actual)

March 16, 2021

Study Record Updates

Last Update Posted (Actual)

March 16, 2021

Last Update Submitted That Met QC Criteria

March 11, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-6049-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson Disease

Clinical Trials on walking speed

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe