PaDAWAn: Parkinson's Disease - Adaptive Walking Assistance

Parkinson Disease Clinical Trial

— PaDAWAn  

Official title:

PaDAWAn: Parkinson's Disease - Adaptive Walking Assistance

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04314973
• Other study ID #: PaDAWAn
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 27, 2022
• Est. completion date: June 2023

Study information

• Verified date: June 2022
• Source: Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 41
• Est. completion date: June 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Active Pelvis Orthosis
Walking with the robotic device providing the assistive protocol.

Other:
• Walking exercises
Walking exercises without wearing the robotic device.

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

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