Walking With the EksoNR in Stroke Patients and Healthy Controls: Biomechanical Changes and User Experience.
Stroke, Healthy
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
This study will test a group of stroke patients and a group of healthy subjects in each condition.
To assess communication, memory and understanding the Montreal Cognitive Assessment (MoCA) written test is going to be carried out. This test is a valid assessment of cognitive abilities, such as orientation, short-term memory, executive visuospatial ability, language abilities, abstraction, and attention. To enrol in this study, both people (post-stroke and healthy controls) need to do a MoCA test and have more than 25 points on the MoCA test
Inclusion Criteria for people post-stroke:
- 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.
Exclusion Criteria for people post-stroke:
- 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.
Exclusion Criteria for healthy 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).
Exclusion criteria related to the use of the EksoNR :
- 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.
- Psychiatric or cognitive situations that may interfere with the proper operation of the device.
- Cognitive impairments resulting in the inability to follow directions.
- Pregnancy.
- Colostomy.
- Poor skin integrity in areas in contact with the device.
- Decreased standing tolerance due to orthostatic hypotension.
- Range of motion restrictions that would prevent a patient from achieving a normal, reciprocal gait pattern, or would restrict a patient from completing normal sit-to-stand or stand-to-sit transitions: Knee flexion contracture greater than 12° and inability to achieve 0° neutral angle dorsiflexion with knee flexion up to 12°.
- Leg length discrepancy greater than 1.27 cm for thighs or 1.91 cm for lower legs.
- Unresolved deep vein thrombosis.
- Uncontrolled autonomic dysreflexia.
- Lower limb prosthesis.
Requirements for the use of the EksoNR:
- Weigh 100 kg or less.
- Between 1.5 m and 1.88 m tall.
- Have a standing hip width of 45 cm or less.
- Have a near-normal range of motion in hips, knees, and ankles.
- Able to attain neutral ankle dorsiflexion with <12 degrees of knee flexion contracture.
- Upper leg length discrepancy must be equal to or less than 1.27 cm and lower leg discrepancy equal to or less than 1.91 cm.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Stroke
Healthy