Provocation of Freezing of Gait in Parkinson's Disease

Study Overview
=================
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.

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

Conditions
-----------------
Parkinson Disease, Freezing of Gait

Intervention / Treatment
-----------------
* Other: walking speed
* Other: visual loading
* Other: dual task
* Other: best side reduction


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of freezing of gait | 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 | 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 | Comparison between two groups | Within intervention (2mins for each situation) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
freezing, spilt-belt, Dual task, visual, Parkinson