Status:
UNKNOWN
Walking With the EksoNR in Stroke Patients and Healthy Controls: Biomechanical Changes and User Experience.
Lead Sponsor:
Vrije Universiteit Brussel
Collaborating Sponsors:
Universitair Ziekenhuis Brussel
Conditions:
Stroke
Healthy
Eligibility:
All Genders
18-80 years
Phase:
NA
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. Patie...
Detailed Description
Stroke is the leading cause of severe disability in adults resulting in mobility, balance, and coordination deficits. Because of this, walking recovery has a significant impact on stroke patients' qua...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05334030
Start Date
April 25 2022
End Date
December 1 2022
Last Update
April 19 2022
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