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Completed

NCT Number: NCT03638089

Fall Recovery Training for Individuals With Chronic Stroke

The purpose of this study is to quantify how fall-recovery training improves the fall-recovery response of individuals with chronic stroke. Up to 20 participants with chronic stroke will be recruited from the community. Over six laboratory visits, participants will undergo sessions of fall-recovery training. Each session is comprised of simulated trips and slips as participants stand on a computer-controlled treadmill. Trip-recovery training consists of treadmill-delivered disturbances that induce a forward fall. Slip-recovery training consists of a treadmill-delivered disturbances that induce a backward fall. Separate progressions focus on initial steps with the left and right limbs. The training intensity, as determined by the disturbance magnitude, is progressive and dependent on participant performance. Step length and maximum trunk angle will be calculated. The hypothesis is that, with practice, participants will recover from larger perturbations, and they will increase step length and reduce trunk rotation during fall recoveries.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must be 18 years or older
  • Participants must have had a single stroke of non-cerebellar origin

Exclusion criteria

  • More than one stroke
  • Unable to walk one block without stopping or using a walking aid, such as a cane
  • Acute illness at the time of functional assessment or training
  • Body mass greater than 136 kg (300 lbs)
  • Lower extremity joint replacement or shoulder joint replacement within a year prior to participation
  • Dementia
  • Parkinson's disease
  • A history of back surgery
  • A history of neck surgery
  • More than one occurrence of back or neck pain in the month prior to participation
  • Current back or neck pain at the time of participant enrollment
  • Bulging vertebral discs
  • Spine, hip, or lower extremity fracture within a year prior to participation
  • Open lesions on the lower extremity
  • Insulin-dependent diabetes
  • Use of a pacemaker
  • Use of an ostomy pouch
  • Pregnancy
  • Osteoporosis
  • Doctor recommendation to avoid moderate physical activity or exercise
  • Any neural, muscular, or skeletal condition or injury that precludes safe participation in the training or introduces a confounding factor on the study, at the discretion of the clinician or study staff

Treatment and study plan

Fall-recovery training

Behavioral

Participants practice recovering from simulated, treadmill-induced slips and trips.

Primary outcomes

  1. Disturbance magnitude

    Time frame: 2-3 weeks (first to last training session)

    The highest disturbance magnitude from which a successful fall-recovery resulted on the first and last training sessions

Secondary outcomes

  1. Step length

    Time frame: 2-3 weeks (first to last training session)

    The length of the initial recovery step in response to the highest disturbance magnitude common to the first and last training sessions

  2. Trunk rotation

    Time frame: 2-3 weeks (first to last training session)

    The maximum trunk rotation angle in response to the highest disturbance magnitude common to the first and last training sessions

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Aug 20, 2018
Registry last updated
Sep 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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