RecruitingNot ApplicableNCT06400186

Movement Amplification Gait Training to Enhance Walking Balance Post-Stroke


Sponsor

VA Office of Research and Development

Enrollment

30 participants

Start Date

Aug 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Stroke is a leading cause of disability in the United States, affecting approximately 795,000 people annually. The Veteran's Health Administration provides over 60,000 outpatient visits for stroke-related care annually at a cost of over $250 million. Among ambulatory people with chronic stroke (PwCS), impaired balance is a common health concern that substantially limits mobility (those with the worst balance walk the least). This project will explore adaptive strategies employed by PwCS in balance challenging environments and if a novel gait training intervention using a robotic device to amplify a person's self-generated movements can improve walking balance. The development of effective interventions to increase walking balance among PwCS will positively impact Veterans' health, quality of life, and ability to participate in walking activities.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria3

  • History of chronic stroke (more than 6 months post-stroke) with weakness on one side
  • Ability to ambulate over ground for 10 meters with or without a single cane, and/or ankle-foot orthosis
  • Ability to tolerate 10 minutes of standing

Exclusion Criteria11

  • Presence of cognitive impairment (score of 22/30 on the Montreal Cognitive Assessment scale (MoCA))
  • Presence of aphasia (score of 71/100 on the Mississippi Aphasia Screening Test (MAST))
  • Excessive spasticity in lower limbs (score of > 3 on the Modified Ashworth Scale
  • Severe cardiovascular and pulmonary disease affecting gait and balance
  • History of recurrent fractures or known orthopedic problems in the lower extremities (i.e. heterotopic ossification) affecting gait and balance
  • Concomitant central or peripheral neurological injury (i.e. traumatic head injury or peripheral nerve damage in lower limbs) affecting gait and balance
  • Evidence of cerebellar ataxia
  • Presence of unhealed decubiti or other skin compromise
  • Enrollment in concurrent physical therapy or research involving gait or balance training
  • Use of braces/orthotics crossing the knee joint
  • Known pregnancy

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Interventions

BEHAVIORALHigh intensity gait training in varying external environments

Participants will engage in two 45-minutes treadmill-based gait training sessions. These training sessions will occur on separate days. One session will be performed in a natural unmodified environment. One session will be performed in a movement amplification environment. The goal of each session will be to achieve 40-minutes of walking within a target heart rate range of 70-85% of estimated heart rate max. Each session will begin and end with a 2.5 minute warm-up and cool down respectively. Participants will be given rest breaks as needed.

BEHAVIORALTreadmill walking in varying external environments

Participants will perform a series of treadmill walking trials. Each trial will consist of 400 total steps. The first 100 steps will be performed in a natural unmodified environment. The next 200 steps will be performed in 1 of 3 external environments (natural unmodified, movement amplification, or unpredictable lateral perturbations). The final 100 steps will be performed in a natural unmodified environment. Participants will be given rest breaks between trials.


Locations(2)

Northwestern University

Chicago, Illinois, United States

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, United States

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NCT06400186