N/A
Completed N=14
Comparison of Two High-intensity Gait Training Interventions on Contraversive Pushing Behaviors in Individuals Poststroke
Source: ClinicalTrials.gov NCT04550039 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcomePrimary: Change in Scale for Contraversive Pushing — -47.01; -59.72 percent change in points
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Scale for Contraversive Pushing |
-47.01; -59.72 | — |
| PRIMARY Change in Burke Lateropulsion Scale |
-67.5; -53.99 | — |
| SECONDARY Change in 10 Meter Walk Test |
143.33; 220.37 | — |
| SECONDARY Change in 6 Minute Walk Test |
267.65; 261.42 | — |
| SECONDARY Change in Berg Balance Scale |
73.33; 371.67 | — |
| SECONDARY Change in Function in Sitting Test |
70.57; 58.15 | — |
| SECONDARY Change in Functional Independence Measure |
— | — |
| SECONDARY Change in Quality Indicators |
— | — |
| SECONDARY Change in Manual Muscle Test |
— | — |
| SECONDARY Change in Passive Range of Motion |
— | — |
| SECONDARY Change in Modified Ashworth Scale |
— | — |
| SECONDARY Median Steps Per Session |
1449; 649; 1513; 727; 1505; 1091 | — |
| SECONDARY Maximum Heart Rate |
104; 119; 118; 124; 118; 124 | — |
| SECONDARY Maximum Borg Rating of Perceived Exertion |
15; 14; 15; 16; 15; 14 | — |
| SECONDARY Numerical Rating Pain Scale |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT04550039). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.