Clinical trial NCT04550039: Comparison of Two High-intensity Gait Training Interventions on Contraversive Pushing Behaviors in Individuals Poststroke
Official title: Comparison of Two High-intensity Gait Training Interventions on Contraversive Pushing Behaviors in Individuals Poststroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Gait
Exoskeleton
Robotics
Contraversive pushing behaviors
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Change in Scale for Contraversive Pushing
timeFrame: Baseline, 3 weeks
measure: Change in Burke Lateropulsion Scale
timeFrame: Baseline, 3 weeks
Secondary outcomes:
measure: Change in 10 Meter Walk Test
timeFrame: Baseline, 3 weeks
measure: Change in 6 Minute Walk Test
timeFrame: Baseline, 3 weeks
measure: Change in Berg Balance Scale
timeFrame: Baseline, 3 weeks
measure: Change in Function in Sitting Test
timeFrame: Baseline, 3 weeks
measure: Change in Functional Independence Measure
timeFrame: Baseline, 3 weeks
measure: Change in Quality Indicators
timeFrame: Baseline, 3 weeks.
measure: Change in Manual Muscle Test
timeFrame: Baseline, 3 weeks
measure: Change in Passive Range of Motion
timeFrame: Baseline, 3 weeks.
measure: Change in Modified Ashworth Scale
timeFrame: Baseline, 3 weeks
measure: Median Steps Per Session
timeFrame: Week 1, Week 2, Week 3
measure: Maximum Heart Rate
timeFrame: Week 1, Week 2, Week 3
measure: Maximum Borg Rating of Perceived Exertion
timeFrame: Week 1, Week 2, Week 3
measure: Numerical Rating Pain Scale
timeFrame: Week 1, Week 2, Week 3
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Arun Jayaraman, PhD
role: PRINCIPAL_INVESTIGATOR
References: