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PaDAWAn: Parkinson's Disease - Adaptive Walking Assistance

PaDAWAn: Parkinson's Disease - Adaptive Walking Assistance

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04314973
Acronym
PaDAWAn
Enrollment
41
Registered
2020-03-19
Start date
2022-01-27
Completion date
2023-06-30
Last updated
2022-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Exoskeleton, Active Pelvis Orthosis

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.

Interventions

DEVICEActive Pelvis Orthosis

Walking with the robotic device providing the assistive protocol.

OTHERWalking exercises

Walking exercises without wearing the robotic device.

Sponsors

Université Catholique de Louvain
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Long-Range Autocorrelation (LRA)From day 0 up to 8 weeksAssesses the variability between stride durations

Secondary

MeasureTime frameDescription
Activities-Specific Balance Confidence Scale (ABC)From day 0 up to 8 weeksSelf reported measure of balance confidence in performing various activities
Balance Evaluation Systems Test (BESTest)From day 0 up to 8 weeksThe balance of subjects is tested during 6 postural control contexts
Gait analysisFrom day 0 up to 8 weeksAverage stride length and duration, gait symmetry, hips range of motion
Unified Parkinson's disease rating scales (UPDRS)From day 0 up to 8 weeksAssesses the disease stage and severity
Physiological Cost IndexFrom day 0 up to 8 weeksIn order to assess the metabolic efforts associated to walking
System Usability Scale (SUS)After 4 weeksSelf reported measure of the fatigue and stress felt by patients
Joint torquesFrom day 0 up to 8 weeksIn order to assess the mechanical efforts associated to walking

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026