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Clinical Trials/NCT04550039
NCT04550039
Completed
N/A

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

Shirley Ryan AbilityLab1 site in 1 country14 target enrollmentJanuary 1, 2021
ConditionsStroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
Shirley Ryan AbilityLab
Enrollment
14
Locations
1
Primary Endpoint
Change in Scale for Contraversive Pushing
Status
Completed
Last Updated
2 years ago

Overview

Brief 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. 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

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
December 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Arun Jayaraman, PT, PhD

Research Scientist

Shirley Ryan AbilityLab

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Scale for Contraversive Pushing

Time Frame: Baseline, 3 weeks

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.

Change in Burke Lateropulsion Scale

Time Frame: Baseline, 3 weeks

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.

Secondary Outcomes

  • Change in Functional Independence Measure(Baseline, 3 weeks)
  • Change in Passive Range of Motion(Baseline, 3 weeks.)
  • Maximum Heart Rate(Week 1, Week 2, Week 3)
  • Numerical Rating Pain Scale(Week 1, Week 2, Week 3)
  • Change in Quality Indicators(Baseline, 3 weeks.)
  • Change in Manual Muscle Test(Baseline, 3 weeks)
  • Change in Berg Balance Scale(Baseline, 3 weeks)
  • Change in Modified Ashworth Scale(Baseline, 3 weeks)
  • Median Steps Per Session(Week 1, Week 2, Week 3)
  • Change in 10 Meter Walk Test(Baseline, 3 weeks)
  • Change in 6 Minute Walk Test(Baseline, 3 weeks)
  • Change in Function in Sitting Test(Baseline, 3 weeks)
  • Maximum Borg Rating of Perceived Exertion(Week 1, Week 2, Week 3)

Study Sites (1)

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