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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Walking exercises; Device: Active 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.

• Study Type: Interventional
• Enrollment (Anticipated): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint-Luc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

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

Number of Arms

2

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.	Other: Walking exercises; Walking exercises without wearing the robotic device.
EXPERIMENTAL: Intervention phase; Patients will walk with the robotic device, for 12 sessions of 10 min.	Device: Active Pelvis Orthosis; Walking with the robotic device providing the assistive protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-Range Autocorrelation (LRA)	Assesses the variability between stride durations	From day 0 up to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unified Parkinson's disease rating scales (UPDRS)	Assesses the disease stage and severity	From day 0 up to 8 weeks
Activities-Specific Balance Confidence Scale (ABC)	Self reported measure of balance confidence in performing various activities	From day 0 up to 8 weeks
Balance Evaluation Systems Test (BESTest)	The balance of subjects is tested during 6 postural control contexts	From day 0 up to 8 weeks
Gait analysis	Average stride length and duration, gait symmetry, hips range of motion	From day 0 up to 8 weeks
Joint torques	In order to assess the mechanical efforts associated to walking	From day 0 up to 8 weeks
Physiological Cost Index	In order to assess the metabolic efforts associated to walking	From day 0 up to 8 weeks
System Usability Scale (SUS)	Self reported measure of the fatigue and stress felt by patients	After 4 weeks

Collaborators and Investigators

• Sponsor: Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 27, 2022
• Primary Completion (ANTICIPATED): January 1, 2023
• Study Completion (ANTICIPATED): June 1, 2023

Study Registration Dates

• First Submitted: March 11, 2020
• First Submitted That Met QC Criteria: March 16, 2020
• First Posted (ACTUAL): March 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 14, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Exoskeleton; Active Pelvis Orthosis
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: PaDAWAn

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No