Healthy Clinical Trial
Official title:
Walking With the EksoNR in Stroke Patients and Healthy Controls: Biomechanical Changes and User Experience.
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.
Status | Not yet recruiting |
Enrollment | 24 |
Est. completion date | December 2022 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
---|---|
Vrije Universiteit Brussel | Universitair Ziekenhuis Brussel |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | User Experience | The secondary outcome is the acceptance and the experience of the users wearing and walking with the exoskeleton EksoNR. By the end of Session 3, each participant is going to fill an online survey created by the investigators, based on two existing questionnaires: Intrinsic Motivation Inventory (IMI) and Quebec User Evaluation of Satisfaction with assistive Technology 2.0 (QUEST 2.0). The questionnaire consists of six subscales: interest/enjoyment, perceived competence, effort/importance, pressure/tension, value/usefulness and relatedness. All different statements of the six subscales use a 5-point Likert scale, which means that participants give a score of one to five. With a score of one being "not at all true" and five being "very true". A higher score is associated with a higher internal motivation, excluding the pressure/ tension scale where a higher score is associated with a higher feeling of pressure . | Filled out by both the stroke and healthy patients immediately after the end of session 3 (day 3). |
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