- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04314973
PaDAWAn: Parkinson's Disease - Adaptive Walking Assistance (PaDAWAn)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Brussels, Belgium, 1200
- Cliniques Universitaires Saint-Luc
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Evaluation sessions
Patients will be evaluated while walking without wearing the robotic device, once before the intervention phase, once right after, and once a month after.
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Walking exercises without wearing the robotic device.
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EXPERIMENTAL: Intervention phase
Patients will walk with the robotic device, for 12 sessions of 10 min.
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Walking with the robotic device providing the assistive protocol.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Long-Range Autocorrelation (LRA)
Time Frame: From day 0 up to 8 weeks
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Assesses the variability between stride durations
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From day 0 up to 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Unified Parkinson's disease rating scales (UPDRS)
Time Frame: From day 0 up to 8 weeks
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Assesses the disease stage and severity
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From day 0 up to 8 weeks
|
Activities-Specific Balance Confidence Scale (ABC)
Time Frame: From day 0 up to 8 weeks
|
Self reported measure of balance confidence in performing various activities
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From day 0 up to 8 weeks
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Balance Evaluation Systems Test (BESTest)
Time Frame: From day 0 up to 8 weeks
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The balance of subjects is tested during 6 postural control contexts
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From day 0 up to 8 weeks
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Gait analysis
Time Frame: From day 0 up to 8 weeks
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Average stride length and duration, gait symmetry, hips range of motion
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From day 0 up to 8 weeks
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Joint torques
Time Frame: From day 0 up to 8 weeks
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In order to assess the mechanical efforts associated to walking
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From day 0 up to 8 weeks
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Physiological Cost Index
Time Frame: From day 0 up to 8 weeks
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In order to assess the metabolic efforts associated to walking
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From day 0 up to 8 weeks
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System Usability Scale (SUS)
Time Frame: After 4 weeks
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Self reported measure of the fatigue and stress felt by patients
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After 4 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PaDAWAn
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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