Clinical trial NCT04314973: PaDAWAn: Parkinson's Disease - Adaptive Walking Assistance
Official title: PaDAWAn: Parkinson's Disease - Adaptive Walking Assistance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Exoskeleton
Active Pelvis Orthosis
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2020-03-19
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Long-Range Autocorrelation (LRA)
timeFrame: From day 0 up to 8 weeks
Secondary outcomes:
measure: Unified Parkinson's disease rating scales (UPDRS)
timeFrame: From day 0 up to 8 weeks
measure: Activities-Specific Balance Confidence Scale (ABC)
timeFrame: From day 0 up to 8 weeks
measure: Balance Evaluation Systems Test (BESTest)
timeFrame: From day 0 up to 8 weeks
measure: Gait analysis
timeFrame: From day 0 up to 8 weeks
measure: Joint torques
timeFrame: From day 0 up to 8 weeks
measure: Physiological Cost Index
timeFrame: From day 0 up to 8 weeks
measure: System Usability Scale (SUS)
timeFrame: After 4 weeks
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
References: