PaDAWAn: Parkinson's Disease - Adaptive Walking Assistance

Study Overview
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Brief Summary
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The goal of this study is to develop and validate a haptic assistive method in order to support walking in patients with Parkinson's disease, delivered to the patient's hips through a wearable robotic pelvis orthosis.

Detailed Description
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None of the existing robotic devices used for gait rehabilitation in Parkinson's disease is wearable. Thanks to the wearable robotic pelvis orthosis we will use, the rehabilitation sessions can take place in an ecological environment. The other advantage of the proposed assistance protocol is its adaptability: patients will feel their hips pattern to be smoothed by the robot, but they will keep the freedom of continuously steering their main movement variables (like stride frequency, duration, and length). A key measured metric will precisely rely on this variability between stride durations. Indeed, the degree of stride-to-stride variability was shown to reflect the patient's physiological state, and to be correlated with the stage of the disease. Experimental trials will be conducted to assess both the assistive (i.e. the therapy effect during the therapy itself) and rehabilitative (i.e. effect after the therapy) natures of our protocol. The second main objective of this project will be the analysis of the effects of our protocol regarding the stride-to-stride variability of patients with Parkinson's disease.

Official Title
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PaDAWAn: Parkinson's Disease - Adaptive Walking Assistance

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: Active Pelvis Orthosis
* Other: Walking exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parkinson's disease diagnosis positive according to UK Brain Bank criteria Hoehn and Yahr score of 1 to 3 Mini-mental state (MMSE) higher than 24 Optimal drug treatment for at least 4 weeks at the time of inclusion No contraindication to physical exercising (ACSM criteria) Exclusion Criteria: Not being able to understand French well enough Not being in the targeted age range

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Evaluation sessions<br>Patients will be evaluated while walking without wearing the robotic device, once before the intervention phase, once right after, and once a month after. | Other: Walking exercises<br>* Walking exercises without wearing the robotic device.<br>|
| Experimental: Intervention phase<br>Patients will walk with the robotic device, for 12 sessions of 10 min. | Device: Active Pelvis Orthosis<br>* Walking with the robotic device providing the assistive protocol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-Range Autocorrelation (LRA) | Assesses the variability between stride durations | From day 0 up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unified Parkinson's disease rating scales (UPDRS) | Assesses the disease stage and severity | From day 0 up to 8 weeks | 
| Activities-Specific Balance Confidence Scale (ABC) | Self reported measure of balance confidence in performing various activities | From day 0 up to 8 weeks | 
| Balance Evaluation Systems Test (BESTest) | The balance of subjects is tested during 6 postural control contexts | From day 0 up to 8 weeks | 
| Gait analysis | Average stride length and duration, gait symmetry, hips range of motion | From day 0 up to 8 weeks | 
| Joint torques | In order to assess the mechanical efforts associated to walking | From day 0 up to 8 weeks | 
| Physiological Cost Index | In order to assess the metabolic efforts associated to walking | From day 0 up to 8 weeks | 
| System Usability Scale (SUS) | Self reported measure of the fatigue and stress felt by patients | After 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exoskeleton, Active Pelvis Orthosis