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PaDAWAn: Parkinson's Disease - Adaptive Walking Assistance (PaDAWAn)

Primary Purpose

Parkinson Disease

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Active Pelvis Orthosis
Walking exercises
Sponsored by
Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Exoskeleton, Active Pelvis Orthosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Cliniques universitaires Saint-Luc

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Evaluation sessions

Intervention phase

Arm 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.

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

Outcomes

Primary Outcome Measures

Long-Range Autocorrelation (LRA)
Assesses the variability between stride durations

Secondary Outcome Measures

Unified Parkinson's disease rating scales (UPDRS)
Assesses the disease stage and severity
Activities-Specific Balance Confidence Scale (ABC)
Self reported measure of balance confidence in performing various activities
Balance Evaluation Systems Test (BESTest)
The balance of subjects is tested during 6 postural control contexts
Gait analysis
Average stride length and duration, gait symmetry, hips range of motion
Joint torques
In order to assess the mechanical efforts associated to walking
Physiological Cost Index
In order to assess the metabolic efforts associated to walking
System Usability Scale (SUS)
Self reported measure of the fatigue and stress felt by patients

Full Information

First Posted
March 11, 2020
Last Updated
June 14, 2022
Sponsor
Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT04314973
Brief Title
PaDAWAn: Parkinson's Disease - Adaptive Walking Assistance
Acronym
PaDAWAn
Official Title
PaDAWAn: Parkinson's Disease - Adaptive Walking Assistance
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 27, 2022 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Exoskeleton, Active Pelvis Orthosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Evaluation sessions
Arm Type
Active Comparator
Arm 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.
Arm Title
Intervention phase
Arm Type
Experimental
Arm Description
Patients will walk with the robotic device, for 12 sessions of 10 min.
Intervention Type
Device
Intervention Name(s)
Active Pelvis Orthosis
Intervention Description
Walking with the robotic device providing the assistive protocol.
Intervention Type
Other
Intervention Name(s)
Walking exercises
Intervention Description
Walking exercises without wearing the robotic device.
Primary Outcome Measure Information:
Title
Long-Range Autocorrelation (LRA)
Description
Assesses the variability between stride durations
Time Frame
From day 0 up to 8 weeks
Secondary Outcome Measure Information:
Title
Unified Parkinson's disease rating scales (UPDRS)
Description
Assesses the disease stage and severity
Time Frame
From day 0 up to 8 weeks
Title
Activities-Specific Balance Confidence Scale (ABC)
Description
Self reported measure of balance confidence in performing various activities
Time Frame
From day 0 up to 8 weeks
Title
Balance Evaluation Systems Test (BESTest)
Description
The balance of subjects is tested during 6 postural control contexts
Time Frame
From day 0 up to 8 weeks
Title
Gait analysis
Description
Average stride length and duration, gait symmetry, hips range of motion
Time Frame
From day 0 up to 8 weeks
Title
Joint torques
Description
In order to assess the mechanical efforts associated to walking
Time Frame
From day 0 up to 8 weeks
Title
Physiological Cost Index
Description
In order to assess the metabolic efforts associated to walking
Time Frame
From day 0 up to 8 weeks
Title
System Usability Scale (SUS)
Description
Self reported measure of the fatigue and stress felt by patients
Time Frame
After 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Cliniques universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

PaDAWAn: Parkinson's Disease - Adaptive Walking Assistance

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