Perturbation Training for Fall-risk Reduction Among Stroke Survivors
The long-term objective of this research is to develop an efficacious training paradigm to enhance stroke survivors' defense mechanisms against falls and possibly reduce healthcare cost. The Centers for Disease Control and Prevention estimates the direct medical cost for fall related injuries to be $34 billion annually. Forty percent to 70% of community-dwelling stroke survivors experience detrimental falls each year and tend to have 1.5 to 4 times higher risk of hip fracture than their healthy counterparts; with only less than 40% of those individuals regaining independent mobility. Falls, thus not only affect activities of daily living but also reduce mobility, increase risk of second stroke and mortality. Despite potential financial and functional implications of falls in this population, health-care personnel are limited in their ability to develop and validate interventions to reduce fall-risk for them. Further emphasis is placed on locomotor training with focus on enhancing paretic limb function. The project design consists of a randomized controlled trial to examine the ability of chronic stroke survivors to acquire, generalize and retain adaptations to slip-perturbation training for not only mitigating fall risk but also improving walking function. It also explores translation of this paradigm to the sub-acute population. The paradigm is novel in that it targets contributions of the paretic vs. non-paretic limbs on fall-risk through a bilateral training paradigm that involves training the non-paretic side first and then paretic to facilitate acquisition of fall-prevention skills on the paretic side, which may otherwise take longer to acquire training effects. The longer-term benefits of such perturbation training, targeting both limbs for reducing falls will be assessed not only in the laboratory but also in real life via wearable sensors, along with improved community walking function. The hypothesis of this study if supported by the results will provide an evidence-supported training protocol to reduce the fall-risk not only in people living with hemiparetic stroke but also among survivors of other acquired unilateral cortical lesions.
Conditions:
🦠 Stroke
🗓️ Study Start (Actual) 2 May 2017
🗓️ Primary Completion (Estimated) 31 August 2025
✅ Study Completion (Estimated) 31 August 2025
👥 Enrollment (Estimated) 181
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Chicago, Illinois, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Subjects will have to be ambulatory (with or without assistive device) with self-reported chronic (\> 6 months) stroke-induced hemiparesis confirmed by participants' physician and medically cleared. Evidence of unilateral brain lesion confirmed by an imaging study (e.g. CT or MRI).
    • * Subjects with no other acute and significant neurological, cardiopulmonary, musculoskeletal or systemic diagnosis or have undergone a recent major surgery (\<6 months) or hospitalization (\<3 months) and not on any sedative drugs
    • * Ability to walk at least 10m with or without assistive device which includes use of ankle orthosis or functional electrical stimulation devices (which is equivalent to having a score of\> 4, dependent supervision on Functional Ambulatory category scale)

    Exclusion Criteria:

    • * Severe osteoporosis (Ultrasound score \< -2)
    • * Cognitive impairment (Mini Mental State Exam score\<25)
    • * Aphasia (\<71% on Mississippi Aphasia Screening Test)
    • * Severe depression ( \> 15 on Geriatric Depression Scale)
    • * Severe obesity (BMI \>35Kilogram/m2)
    • * Complains of shortness of breath, or uncontrolled pain (\> 3/10 on VAS), or if pulse oxygen drops \<92% on the 6 minute walk test (for endurance)
    • * Uncontrolled hypertension (resting systolic blood pressure \> 165 mmHg and/or diastolic blood pressure \> 110mmHg)
    • * Resting heart rate \> 85% of age-predicted maximal heart rate
    • * Resting oxygen saturation \<95%
Ages Eligible for Study: 21 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 23 June 2017
  • First Submitted that Met QC Criteria 29 June 2017
  • First Posted 2 July 2017

Study Record Updates

  • Last Update Submitted that Met QC Criteria 14 May 2024
  • Last Update Posted 16 May 2024
  • Last Verified May 2024