Walking With the EksoNR in Stroke Patients and Healthy Controls: Biomechanical Changes and User Experience.

Summary

Further studies are needed to provide more detailed information on the potential effects of robotic gait training in general, as well as on the influence on gait movement patterns in particular. Patient perspectives and feedback contribute to the continuous development of exoskeletal technology. For these reasons, the main objective of this study is to decipher the relationship between EksoNR's robotic control settings and walking biomechanics in stroke patients and healthy subjects; the second objective is to discover the user experience during the use of EksoNR.

Conditions

• Stroke
• Healthy

Interventions

DEVICE

High Swing Assistance

On this study, four settings are going to be evaluated being that High Swing Assistance, Neutral Swing Assistance, High Swing Resistance and Max Trajectory Control. The following settings will be used in all three conditions: * Sitting program - "Min lean"; * Standing program - "Auto lean"; * Step initiation program - "ProStep+", * Training mode - "Off", * SmartAssist option - "2Free"; * Stance support - "Low". The level of stance support and swing assistance will be set symmetrically for the affected and non-affected side. Each patient is going to walk 7 min (or min 25 gait cycles) with every setting

DEVICE

Neutral Swing Assistance

On this study, four settings are going to be evaluated being that High Swing Assistance, Neutral Swing Assistance, High Swing Resistance and Max Trajectory Control. The following settings will be used in all three conditions: * Sitting program - "Min lean"; * Standing program - "Auto lean"; * Step initiation program - "ProStep+", * Training mode - "Off", * SmartAssist option - "2Free"; * Stance support - "Low". The level of stance support and swing assistance will be set symmetrically for the affected and non-affected side. Each patient is going to walk 7 min (or min 25 gait cycles) with every setting

DEVICE

High Swing Resistance

On this study, four settings are going to be evaluated being that High Swing Assistance, Neutral Swing Assistance, High Swing Resistance and Max Trajectory Control. The following settings will be used in all three conditions: * Sitting program - "Min lean"; * Standing program - "Auto lean"; * Step initiation program - "ProStep+", * Training mode - "Off", * SmartAssist option - "2Free"; * Stance support - "Low". The level of stance support and swing assistance will be set symmetrically for the affected and non-affected side. Each patient is going to walk 7 min (or min 25 gait cycles) with every setting

DEVICE

Max Trajectory Control

On this study, four settings are going to be evaluated being that High Swing Assistance, Neutral Swing Assistance, High Swing Resistance and Max Trajectory Control. The following settings will be used in all three conditions: * Sitting program - "Min lean"; * Standing program - "Auto lean"; * Step initiation program - "ProStep+", * Training mode - "Off", * SmartAssist option - "Bilateral"; * Stance support - "Low". The level of stance support and swing assistance will be set symmetrically for the affected and non-affected side. Each patient is going to walk 7 min (or min 25 gait cycles) with every setting

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel

  collaborator OTHER

• Vrije Universiteit Brussel

  lead OTHER

Principal Investigators

• EVA SWINNEN, Prof. Ph.D · Vrije Universiteit Brussel

• Chiara Cavallaro, Bachelor's · Vrije Universiteit Brussel

• Joana Brites, Master's · Vrije Universiteit Brussel

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-04-25

Primary Completion

2022-12-31

Completion

2022-12-31

FDA Device

Yes