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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Body-weight-supported treadmill; Device: Ekso Bionics EksoNR exoskeleton

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Shirley Ryan AbilityLab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Scale for Contraversive Pushing	The Scale for Contraversive Pushing is a three-item test used to measure lateropulsion also known as contraversive pushing behaviors. It is 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 in each section indicates the presence of contraversive pushing behaviors. The maximum score is 6. The minimum score is 0, indicating an absence of pushing behaviors. The lower the score, the better.	Baseline, 3 weeks
Change in 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. A lower score is better. The minimum score is 0, indicating the absence of contraversive pushing behaviors. The maximum score is 17. Research indicates a score of ≥2 as a cutoff for the presence of contraversive pushing behaviors.	Baseline, 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 10 Meter Walk Test	The 10 Meter Walk Test is a common clinical measure of gait speed. Participants are directed to walk at their comfortable, self-selected speed. Participants are positioned at the start line and instructed to walk the entire 10 meter distance while the therapist times the middle six meters. The two meter distance before and after the timed course is meant to minimize the effect of acceleration and deceleration. Time is recorded to the one hundredth of a second (example: 2.46 seconds). The test is performed two times at self-selected speed. The average of the two times is used to calculate velocity in m/s. The minimum gait speed is zero meters/second meaning the participant is unable to ambulate without someone else dependently advancing his/her limb or 2 or more people are required to assist with ambulation. There is no set maximum score. A higher score in meters/second means the participant can ambulate at a faster velocity or gait speed, which is better.	Baseline, 3 weeks
Change in 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. Minimum score is zero meters, meaning the participant is unable to ambulate in any given time. There is no set maximum score as the participant is instructed to ambulate the longest distance possible in six minutes. This test is typically measured in meters or feet. A higher value indicates the participant walked a further distance, which is better.	Baseline, 3 weeks
Change in 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. The minimum score is 0 and the maximum score is 56. A higher score is better.	Baseline, 3 weeks
Change in 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. The minimum score is 0 and the maximum score is 56. A higher score is better.	Baseline, 3 weeks
Change in 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 1point, indicating total assistance, to 7 points, indicating total independence. A higher score is better. Items include eating, grooming, bathing, dressing, toileting, bladder/bowel management, transfers, locomotion, stairs, comprehension, expression, social interaction, problem solving, and memory.	Baseline, 3 weeks
Change in 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 6-independent to 1-dependent. A higher sore is better. Items can also be coded as participant refuses, not applicable, environmental limitations, not attempted due to medical condition or safety concerns, or unplanned discharge.	Baseline, 3 weeks.
Change in 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). 0 is a minimum score and 5 is the maximum score. A higher score is better.	Baseline, 3 weeks
Change in 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. The minimum value being 0 degrees and the maximum value varies based on joint. Normative values are different based on joint. Typically, a higher value is better.	Baseline, 3 weeks.
Change in 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. one is scored by passively moving the individual's limb and assessing the amount of resistance to movement felt by the examiner. A score of 0 (minimum) on the scale indicates no increase in tone while a score of 4 (maximum) indicates rigidity. A lower score is better.	Baseline, 3 weeks
Median Steps Per Session	The number of steps taken during each training 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 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. The minimum number of steps is 0 and there is no maximum. A higher number of steps in considered better.	Week 1, Week 2, Week 3
Maximum Heart Rate	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 Tanaka 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 maximum heart rate, in beats per minute, achieved for participants each gait training session utilizing the Polar OH1 Optical Heart Rate Sensor. There is no maximum or minimum value for this measure. Typically, higher is better.	Week 1, Week 2, Week 3
Maximum Borg Rating of Perceived Exertion	The Borg Rating of Perceived Exertion (RPE) 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. A higher is correlated with higher intensity. It is presented to the participant in written format with descriptors to standardize the report of perceived exertion across tasks.	Week 1, Week 2, Week 3
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. A lower sore is better.	Week 1, Week 2, Week 3

Collaborators and Investigators

• Sponsor: Shirley Ryan AbilityLab
• Investigators: Principal Investigator: Arun Jayaraman, PhD, Shirley Ryan AbilityLab

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: August 27, 2020
• First Submitted That Met QC Criteria: September 14, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Stroke; Gait; Robotics; Exoskeleton; Contraversive pushing behaviors
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: STU00213155

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes