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NCT04550039Completed

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

Source: ClinicalTrials.gov · Last updated 1 Mar 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
14 (actual)
First submitted
27 Aug 2020
Start date
1 Jan 2021
Primary completion date
31 Dec 2023
Lead sponsor
Shirley Ryan AbilityLab
Diseases
Stroke
NCT number
NCT04550039

What you commit to

  • Study type: Interventional
  • Participants enrolled: 14
  • From 1 Jan 2021 to the primary completion date, 31 Dec 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • History of prior stroke
  • Concurrent neurologic condition (i.e PD, TBI, MS, etc.)
  • Concurrent participation in other lower limb research studies that according to the PI is likely to affect study outcome or confound results

Other illness

  • History of peripheral nerve injury
  • Unresolved deep vein thrombosis (DVT)

Lab values

  • Severe osteoporosis as indicated by physician medical clearance

Other

  • 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
  • Joint contracture or significant spasticity in the lower limbs (Modified Ashworth Scale ≥3)
  • Severe knee, hip, or ankle osteoarthritis
  • Open wounds on surfaces in contact with exoskeleton or harness
  • Unstable spine or unhealed fractures
  • Weight bearing precautions
  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shirley Ryan AbilityLab
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.