PaDAWAn: Parkinson's Disease - Adaptive Walking Assistance

Université Catholique de Louvain

Status: Invitation-only

Conditions: Parkinson Disease

Treatments: Device: Active Pelvis Orthosis; Other: Walking exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT04314973

PaDAWAn

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 41 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

Evaluation sessions

Active Comparator group

Description:

Patients will be evaluated while walking without wearing the robotic device, once before the intervention phase, once right after, and once a month after.

Treatment:

Other: Walking exercises

Intervention phase

Experimental group

Description:

Patients will walk with the robotic device, for 12 sessions of 10 min.

Treatment:

Device: Active Pelvis Orthosis