PaDAWAn: Parkinson's Disease - Adaptive Walking Assistance

Not Applicable

• Conditions: Parkinson Disease
• Interventions: Device: Active Pelvis Orthosis; Other: Walking exercises

• Registration Number: NCT04314973
• Lead Sponsor: Université Catholique de Louvain

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.

Study Timeline

• Study First Submitted: 2020-03-11
• Study First Submitted QC: 2020-03-16
• Study First Posted: 2020-03-19
• Study Start: 2022-01-27
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-14
• Last Update Posted: 2022-06-21
• Primary Completion: 2023-01
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention phase	Active Pelvis Orthosis	Patients will walk with the robotic device, for 12 sessions of 10 min.
Evaluation sessions	Walking exercises	Patients will be evaluated while walking without wearing the robotic device, once before the intervention phase, once right after, and once a month after.

Primary Outcome Measures

Name	Time	Method
Long-Range Autocorrelation (LRA)	From day 0 up to 8 weeks	Assesses the variability between stride durations

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cliniques universitaires Saint-Luc; 🇧🇪 Brussels, Belgium