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StrokeNCT04550039

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

A study testing Body-weight-supported treadmill and Ekso Bionics EksoNR exoskeleton in people with Stroke, run by Shirley Ryan AbilityLab at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Stroke
What is being tested?
Body-weight-supported treadmill and Ekso Bionics EksoNR exoskeleton
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited States
Study dates
1 Jan 2021to 31 Dec 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 33Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Shirley Ryan AbilityLab

    Chicago, Illinois, 60611

Other trials in United States

About this study

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.

Read the 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.

Conditions
Stroke
Being tested
Body-weight-supported treadmill, Ekso Bionics EksoNR exoskeleton
Keywords
Stroke, Gait, Exoskeleton, Robotics, Contraversive pushing behaviors
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Body-weight-supported treadmillDevice

    Gait training performed on treadmill with overhead harness providing necessary body-weight-support with assistance from trained physical therapist

  • Ekso Bionics EksoNR exoskeletonDevice

    Gait training performed overground in EksoNR exoskeleton with assistance from trained physical therapist

Study groups in NCT04550039
Study groupRoleWhat they receive
Body-weight-supported treadmill trainingExperimentalParticipants complete prescribed gait training program for at least three weeks or until they discharge.
Receives: Device: Body-weight-supported treadmill
EksoNR exoskeletonExperimentalParticipants complete prescribed gait training program for at least three weeks or until they discharge.
Receives: Device: Ekso Bionics EksoNR exoskeleton

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 3 weeks

  2. 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.

    Measured: Baseline, 3 weeks

Secondary outcomes (13)
  1. 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.

    Measured: Baseline, 3 weeks

  2. 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.

    Measured: Baseline, 3 weeks

  3. 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.

    Measured: Baseline, 3 weeks

  4. 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.

    Measured: Baseline, 3 weeks

  5. 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.

    Measured: Baseline, 3 weeks

  6. 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.

    Measured: Baseline, 3 weeks.

  7. 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.

    Measured: Baseline, 3 weeks

  8. 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.

    Measured: Baseline, 3 weeks.

  9. 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.

    Measured: Baseline, 3 weeks

  10. 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.

    Measured: Week 1, Week 2, Week 3

  11. 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.

    Measured: Week 1, Week 2, Week 3

  12. 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.

    Measured: Week 1, Week 2, Week 3

  13. 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.

    Measured: Week 1, Week 2, Week 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2020
  2. Study start1 Jan 2021
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04550039
Sponsor's protocol ID
STU00213155
Status last verified
Feb 2024
First submitted
27 Aug 2020
Last updated
1 Mar 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Body-weight-supported treadmill and Ekso Bionics EksoNR exoskeleton in people with Stroke, run by Shirley Ryan AbilityLab at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Scale for Contraversive Pushing (time frame: Baseline, 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.

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