Comparison of Two High-intensity Gait Training Interventions on Contraversive Pushing Behaviors in Individuals Poststroke

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effect of two high-intensity gait training interventions on contraversive pushing behaviors in individuals poststroke in the acute inpatient rehabilitation setting. We will also evaluate the effect of these interventions on functional mobility, strength, balance, and endurance. Furthermore, we intend to measure therapist burden when mobilizing individuals with contraversive pushing behaviors.

Detailed Description
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High-intensity gait training is strongly supported in individuals poststroke to facilitate neuroplastic changes in the brain in order to maximize the recovery of functional independence. Individuals with contraversive pushing behaviors (CPB) poststroke are difficult to mobilize as a result of tilted posture with significant balance impairments, a tendency to push toward their hemiparetic side, and resistance to external correction. CPB has been reported in 12-18% of individuals receiving stroke rehabilitation and often leads to longer lengths of stay, poorer functional outcomes, and institutionalized discharge locations compared to individuals poststroke without CPB. High quality evidence guiding physical therapy intervention, specifically gait training, in individuals with CPB is scarce. Traditional therapeutic interventions in individuals with CPB consists of progressing functional mobility while orienting to midline with various forms of visual and tactile feedback. To further guide best practice in this population, we plan to investigate the effect of two high-intensity gait training interventions on CPB in 10 individuals poststroke in the acute inpatient rehabilitation setting over the course of one year. Individuals from the inpatient stroke unit at the Shirley Ryan AbilityLab will be recruited and placed into one of two intervention groups. Intervention for group one will consist of body-weight-supported treadmill training + overground gait training. Intervention for group two will consist of gait training in the EksoNR exoskeleton + overground gait training. The commercially available EksoNR is approved by the FDA for use in individuals with stroke diagnoses. We will also evaluate the effect of these interventions on functional outcomes including mobility, strength, balance, walking speed, and walking endurance in addition to measuring therapist burden when mobilizing individuals with CPB. Both groups will receive their specified gait training intervention three sessions a week for at least three weeks until they discharge with the goal of maximizing the number of steps within a 60 minute session. Gait training interventions will be progressed to challenge individuals as appropriate in order to reach 70-85% of age-predicted maximum heart rate. A fourth session will be utilized to assess weekly outcome measures as part of the standard of care at the Shirley Ryan AbilityLab. There will be no restrictions set on therapy delivered outside of these intervention training sessions as individuals will be getting other therapies each day as the standard of care.

Official Title
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Comparison of Two High-intensity Gait Training Interventions on Contraversive Pushing Behaviors in Individuals Poststroke

Conditions
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Stroke

Intervention / Treatment
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* Device: Body-weight-supported treadmill
* Device: Ekso Bionics EksoNR exoskeleton


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-80 years old Unilateral, supratentorial ischemic or hemorrhagic stroke within the past six months Medical clearance from primary medical team (signed Medical Clearance form) Contraversive pushing behaviors as determined by a score of >0 on the Scale for Contraversive Pushing Adequate cognitive function as determined by the NIH scale: score ≤1 on question 1b and score =0 on question 1c Informed consent provided by participant or power of attorney English speaking Exclusion Criteria: Severe aphasia limiting ability to express needs or discomfort verbally or nonverbally Severe behavioral neglect as determined by a score of ≥ 21 on Catherine Bergego Scale (CBS) via the Kessler Foundation-Neglect Assessment Process (KF-NAP)16 History of prior stroke Concurrent neurologic condition (i.e PD, TBI, MS, etc.) History of peripheral nerve injury Joint contracture or significant spasticity in the lower limbs (Modified Ashworth Scale ≥3) Severe knee, hip, or ankle osteoarthritis Severe osteoporosis as indicated by physician medical clearance Open wounds on surfaces in contact with exoskeleton or harness Unstable spine or unhealed fractures Weight bearing precautions Unresolved deep vein thrombosis (DVT) Concurrent participation in other lower limb research studies that according to the PI is likely to affect study outcome or confound results Pregnancy EksoNR Exclusion Criteria: Weight >220 lbs (100 kg) Height below 60 inches or above 76 inches Standing hip width of approximately 18 inches or more Joint contractures or range of motion deficits that limit normal range of motion during ambulation Knee flexion contracture greater than 12° Hip flexion contracture greater than 17° Inability to achieve 0° neutral ankle dorsiflexion with knee flexion up to 12° Bilateral hip flexion less than 110° Leg length discrepancy Greater than 0.5 in. (1.27 cm) for upper legs Greater than 0.75 in. (1.91 cm) for lower legs Active heterotopic ossification Significant spasticity in the lower limbs (Modified Ashworth Scale ≥3) High anxiety or claustrophobia Clostridium difficile or other gastrointestinal isolation precautions Colostomy Uncontrolled autonomic dysreflexia Lower limb prosthesis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Body-weight-supported treadmill training<br>Participants complete prescribed gait training program for at least three weeks or until they discharge. | Device: Body-weight-supported treadmill<br>* Gait training performed on treadmill with overhead harness providing necessary body-weight-support with assistance from trained physical therapist<br>|
| Experimental: EksoNR exoskeleton<br>Participants complete prescribed gait training program for at least three weeks or until they discharge. | Device: Ekso Bionics EksoNR exoskeleton<br>* Gait training performed overground in EksoNR exoskeleton with assistance from trained physical therapist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scale for Contraversive Pushing | The Scale for Contraversive Pushing is a three-item test used to measure lateropulsion, scored on a three point ordinal scale. It rates a participant's action/reaction of maintaining or changing a position in both sitting and standing. A score >0 indicates the presence of contraversive pushing behaviors. | up to 8 weeks | 
| Burke Lateropulsion Scale | The Burke Lateropulsion Scale is a five-item test used to measure lateropulsion, scored on a four to five point ordinal scale. It rates a participant's action/reaction of keeping or changing a position in sitting, standing, rolling in supine, transfers, and walking. | up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10 Meter Walk Test | The 10 Meter Walk Test is a common clinical measure of gait speed. Participants will be directed to walk at their comfortable, self-selected speed. Participants will be positioned at the start line and instructed to walk the entire 10 meter distance while the therapist times the middle six meters. The distance before and after the timed course are meant to minimize the effect of acceleration and deceleration. Time will be recorded using a stopwatch and recorded to the one hundredth of a second (ex: 2.46 sec). The test will be performed two times at self-selected speed with adequate rest in between. The average of the two times should be recorded. The test will then be repeated with the participants directed to walk at their fast but safe speed. Appropriate assistive devices, bracing, and the minimal amount of physical assistance from the physical therapist will be applied. | Once weekly, through completion of study up to 8 weeks | 
| 6 Minute Walk Test | The 6 Minute Walk Test measures the distance a participant can walk indoors on a flat, hard surface in a period of six minutes. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The test is self-paced. Participants are allowed to stop and rest during the test; however, the timer does not stop. If a participant is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded. Appropriate assistive devices, bracing, and the minimal amount of physical assistance from the physical therapist will be applied. | Once weekly, through completion of study up to 8 weeks | 
| Berg Balance Scale | The Berg Balance Scale is a 14-item test, scored on a five point ordinal scale. It measures functional balance in a clinical setting and includes static and dynamic tasks (such as sitting, standing, transitioning from sitting to standing, standing on one foot, retrieving an object from the floor), during which participants must maintain their balance. | Once weekly, through completion of study up to 8 weeks | 
| Function in Sitting Test | The Function in Sitting Test is a 14-item test of sitting balance, scored on a five point ordinal scale. It measures sensory, motor, proactive, reactive, and steady state balance factors. | Once weekly, through completion of study up to 8 weeks | 
| Functional Independence Measure | The Functional Independence Measure is an 18-item test (13 motor tasks, 5 cognitive tasks) for evaluating level of disability and how much assistance is needed for a participant to perform certain activities of daily living. Each item is scored on a seven point ordinal scale, ranging from total assistance to total independence. Items include eating, grooming, bathing, dressing, toileting, bladder/bowel management, transfers, locomotion, stairs, comprehension, expression, social interaction, problem solving, and memory. | Once weekly, through completion of study up to 8 weeks | 
| Quality Indicators | This is a standardized, evidence-based measure of health care quality used to track clinical performance and outcomes in post-acute care. Items are scored on a six point ordinal scale, ranging from independent to dependent. Items can also be coded as participant refuses, not applicable, environmental limitations, not attempted due to medical condition or safety concerns, or unplanned discharge. | Once weekly, through completion of study up to 8 weeks | 
| Manual Muscle Test | Manual Muscle Test is a procedure for evaluating the strength of 16 individual muscles relative to gravity and manual resistance. Instructions are provided to the participant before testing each muscle. A muscle is isolated, and gradual external force is applied at a right angle to the muscle's long axis. Each muscle is scored on a graded scale of weak to strong based on the participant's ability to resist the external force. The test is first completed for muscles on the unimpaired side to determine normal strength before being repeated on the impaired side. Weaker participants may be tested while lying prone (gravity eliminated). | Once weekly, through completion of study up to 8 weeks | 
| Passive Range of Motion | The purpose of this test is to evaluate a participant's passive range of motion in the joints of the hips, knees, and ankles. | Once weekly, through completion of study up to 8 weeks | 
| Modified Ashworth Scale | The Modified Ashworth Scale is a 6-point ordinal scale used to grade the amount of hypertonicity in individuals with neurological diagnoses. A score of 0 on the scale indicates no increase in tone while a score of 4 indicates rigidity. Tone is scored by passively moving the individual's limb and assessing the amount of resistance to movement felt by the examiner. | Once weekly, through completion of study up to 8 weeks | 
| Step count | The number of steps taken during each session will be measured using ActiGraph GT9X Link activity monitors. These devices are small accelerometers that can be worn on a belt and/or on the ankle to record steps and Kcals during an activity. The therapist leading the intervention session will apply the ActiGraph at the beginning of each intervention session and remove it upon completion. | Each session, through completion of study up to 8 weeks | 
| Age-predicted maximum heart rate zone | The target range of 70-85% of age-predicted maximum heart rate will be calculated for each participant utilizing HRmax = 208 - [0.7 × age] as developed by Tanka et al in 2001. It is recommended that clinicians should apply moderate to high-intensity walking training to improve walking speed and endurance individuals poststroke. We will record the amount of time participants spend in their pre-calculated target zone during each gait training session utilizing the Polar OH1 Optical Heart Rate Sensor. | Each session, through completion of study up to 8 weeks | 
| Borg Rating of Perceived Exertion | The Borg Rating of Perceived Exertion is a tool to measure the subjective report of effort, exertion, and fatigue during physical work. It consists of a 15-point scale from 6-20, in which 6=no exertion and 20=absolute maximum exertion. It is presented to the participant in written format with descriptors to standardize the report of perceived exertion across tasks. | Each session, through completion of study up to 8 weeks | 
| Numerical Rating Pain Scale | The Numerical Rating Pain Scale is used to measure the subjective report of pain intensity. It consists of an 11-point scale, 0-10, in which zero indicates no pain and ten indicates the most intense pain imaginable. In this study, therapists will be provided a written format of the NPRS to report their perceived pain following delivery of each intervention session. | Each session, through completion of study up to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Gait, Exoskeleton, Robotics, Contraversive pushing behaviors