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

NCT05334030 | Unknown FDA Device

• 1 other identifier: EksoRehab
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (5)

• Kinematics parameters

  Measured using the Vicon Nexus. For kinematics, the angles of the lower extremities will be determined. Markers will be placed on the pelvis and the lower body both on the right and left side. The kinematics parameters will be measured while walking during the different conditions.

  Data is only going to be collected on session 3 (day 3), between minutes 2 and 6 of recording for each setting. This time frame is used to avoid the effects of the acceleration and deceleration phases at the beginning and at the end of the walk pathway

• Cadence

  Measured using the Vicon Nexus. Markers will be placed on the pelvis and the lower body both on the right and left side. The cadence will be measured while walking during the different conditions.

  Data is only going to be collected on session 3, between minutes 2 and 6 of recording for each setting. This time frame is used to avoid the effects of the acceleration and deceleration phases at the beginning and at the end of the walk pathway

• Gait speed

  Measured using the Vicon Nexus. Markers will be placed on the pelvis and the lower body both on the right and left side. Gait speed will be measured while walking during the different conditions.

  Data is only going to be collected on session 3 (day 3), between minutes 2 and 6 of recording for each setting. This time frame is used to avoid the effects of the acceleration and deceleration phases at the beginning and at the end of the walk pathway

• Step length

  Measured using the Vicon Nexus. Markers will be placed on the pelvis and the lower body both on the right and left side. Step length will be measured while walking during the different conditions.

  Data is only going to be collected on session 3 (day 3), between minutes 2 and 6 of recording for each setting. This time frame is used to avoid the effects of the acceleration and deceleration phases at the beginning and at the end of the walk pathway

• Muscle Activity

  The EMG Cometa will be used to evaluate muscle activity; therefore, the Electromyography (EMG) wireless sensors will be used. First the position of the anatomical landmarks must be located according to the Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles (SENIAM) guidelines for the following lower extremity muscles: Rectus Femoris (RF), Vastus Lateralis (VL), Vastus Medialis (VM), Biceps Femoris (BF), Tibialis Anterior (TA), Soleus (SOL), Gastrocnemius Lateralis (GL).

  Data is only going to be collected on session 3 (day 3), between minutes 2 and 6 of recording for each setting. This time frame is used to avoid the effects of the acceleration and deceleration phases at the beginning and at the end of the walk pathway

Secondary Outcomes (1)

• User Experience

  Filled out by both the stroke and healthy patients immediately after the end of session 3 (day 3).

Study Arms (2)

Stroke

EXPERIMENTAL

Device: High Swing Assistance; Device: Neutral Swing Assistance; Device: High Swing Resistance; Device: Max Trajectory Control

Healthy

EXPERIMENTAL

Device: High Swing Assistance; Device: Neutral Swing Assistance; Device: High Swing Resistance; Device: Max Trajectory Control

Interventions

High Swing Assistance DEVICE

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

Healthy; Stroke

Neutral Swing Assistance DEVICE

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

Healthy; Stroke

High Swing Resistance DEVICE

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

Healthy; Stroke

Max Trajectory Control DEVICE

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

Healthy; Stroke

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People diagnosed with first-ever stroke (as defined by the WHO);
• Age between 18 and 80 years;
• Time since diagnosis between 1 week and 6 months;
• Functional ambulation category below 3 (meaning a patient who requires intermittent or continuous manual contact to support body weight, maintain balance or assist coordination.);
• Does not meet the Ekso robotic exoskeleton frame limitations (See list below)
• Able to provide written or verbal informed consent.

You may not qualify if:

• Extensive experience with the use of the EksoNR (more than four training sessions);
• Other neurological or musculoskeletal problems leading to impaired gait (unrelated to their stroke);
• Severe complicating comorbidities (e.g., cardiovascular instability, pulmonary diseases);
• Severe deficits of communication, memory or understanding (25 points or less on the MoCA test);
• And contraindications for EksoNR use (see list below).
• A group of healthy participants within the same age category will be used as controls.
• Disabilities leading to impaired gait;
• Severe complicating comorbidities (e.g.: cardiovascular instability, pulmonary diseases);
• Severe deficits of communication, memory or understanding (25 points or less on the MoCA test);
• Contraindications for EksoNR use (see list below).
• Severe concurrent medical conditions: infections, circulatory, heart or lung, pressure sores.
• Severe spasticity (Modified Ashworth 4).
• Unstable spine or unhealed limbs or pelvic fractures.
• Active heterotopic ossification interfering with lower extremity range of motion.
• Significant contractures.

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead
• Universitair Ziekenhuis Brussel: collaborator

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• EVA SWINNEN, Prof. Ph.D

  Vrije Universiteit Brussel

  STUDY DIRECTOR

• Chiara Cavallaro, Bachelor's

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

• Joana Brites, Master's

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva SWINNEN, Prof. Ph.D

CONTACT

003224774527; eva.swinnen@vub.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D, Professor

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 19, 2022
• Study Start: April 25, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 19, 2022

Record last verified: 2022-04