PaDAWAn: Parkinson's Disease - Adaptive Walking Assistance
PaDAWAn
1 other identifier
interventional
41
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable parkinson-disease
Started Jan 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2020
CompletedFirst Posted
Study publicly available on registry
March 19, 2020
CompletedStudy Start
First participant enrolled
January 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedJune 21, 2022
June 1, 2022
11 months
March 11, 2020
June 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Long-Range Autocorrelation (LRA)
Assesses the variability between stride durations
From day 0 up to 8 weeks
Secondary Outcomes (7)
Unified Parkinson's disease rating scales (UPDRS)
From day 0 up to 8 weeks
Activities-Specific Balance Confidence Scale (ABC)
From day 0 up to 8 weeks
Balance Evaluation Systems Test (BESTest)
From day 0 up to 8 weeks
Gait analysis
From day 0 up to 8 weeks
Joint torques
From day 0 up to 8 weeks
- +2 more secondary outcomes
Study Arms (2)
Evaluation sessions
ACTIVE COMPARATORPatients will be evaluated while walking without wearing the robotic device, once before the intervention phase, once right after, and once a month after.
Intervention phase
EXPERIMENTALPatients will walk with the robotic device, for 12 sessions of 10 min.
Interventions
Walking with the robotic device providing the assistive protocol.
Eligibility Criteria
You may qualify if:
- 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
- No contraindication to physical exercising (ACSM criteria)
You may not qualify if:
- Not being able to understand French well enough
- Not being in the targeted age range
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cliniques universitaires Saint-Luc
Brussels, 1200, Belgium
Related Publications (1)
Otlet V, Vandamme C, Warlop T, Crevecoeur F, Ronsse R. Effects of overground gait training assisted by a wearable exoskeleton in patients with Parkinson's disease. J Neuroeng Rehabil. 2023 Nov 16;20(1):156. doi: 10.1186/s12984-023-01280-y.
PMID: 37974229DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2020
First Posted
March 19, 2020
Study Start
January 27, 2022
Primary Completion
January 1, 2023
Study Completion
June 1, 2023
Last Updated
June 21, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share