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Completed

NCT Number: NCT01320839

Effects of an Ankle-Foot Orthosis on Gait While Performing an Attention Demanding Task

We hypothesize that: (1) gait stability will be increased when wearing an ankle-foot orthosis (plastic brace supporting the foot and ankle); (2) an attention demanding task will decrease gait stability and (3) the improvement in gait stability due to ankle-foot orthosis use will be greater during an attention demanding task.

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Key information

About this study

A quasi-experimental, randomized 2 x 2 factorial within subjects study with the factor of walking condition (2 levels, walking with and without ankle-foot orthotic device) and attention condition (2 levels, walking with and without attention task).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • be over the age of 18;
  • have the presence of hemiplegia after stroke;
  • be wearing an ankle-foot orthosis for at least 6 weeks;
  • be able to walk independently and comfortably for a minimum distance of 12 m with or without assistive aids (AFOs, canes and walkers);
  • be able to read and understand English, follow verbal instructions and provide verbal answers to questions;
  • be able to reach criterion on the attention task (described below)
  • be competent to give informed consent as determined by clinical team and noted in the health chart

Exclusion criteria

  • have history of balance deficits not related to stroke;
  • be at high risk of falling during the study;
  • suffer from severe aphasia or dementia as determined by health chart and/or initial cognitive screening using the Montreal Cognitive Assessment (MoCA) test.

Treatment and study plan

Primary outcomes

  1. Velocity

    Time frame: up to one week

    walking velocity

Secondary outcomes

  1. trunk acceleration

    Time frame: up to one week

    trunk acceleration during walking

  2. Step length variability

    Time frame: up to one week

    variability of right and left step length during walking

  3. The Berg Balance Scale

    Time frame: up to one week

    Functional balance measured using the Berg Balance Scale short form.

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Registry information

Official study title

Effects of an Ankle-Foot Orthosis on Gait While Performing an Attention Demanding Task in People With Poststroke Hemiplegia

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 23, 2011
Registry last updated
Mar 7, 2014

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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