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

This study has been completed.
Information provided by (Responsible Party):
Kim Parker, Capital District Health Authority, Canada Identifier:
First received: February 23, 2011
Last updated: March 6, 2014
Last verified: March 2014
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.

Gait, Hemiplegic

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Effects of an Ankle-Foot Orthosis on Gait While Performing an Attention Demanding Task in People With Poststroke Hemiplegia

Resource links provided by NLM:

Further study details as provided by Kim Parker, Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Velocity [ Time Frame: up to one week ]
    walking velocity

Secondary Outcome Measures:
  • trunk acceleration [ Time Frame: up to one week ]
    trunk acceleration during walking

  • Step length variability [ Time Frame: up to one week ]
    variability of right and left step length during walking

  • The Berg Balance Scale [ Time Frame: up to one week ]
    Functional balance measured using the Berg Balance Scale short form.

Enrollment: 21
Study Start Date: March 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
People who have had a stroke and have an ankle-foot orthosis.

Detailed Description:
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).

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
People who have had a hemiplegic stroke and have an ankle-foot orthosis.

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.
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Please refer to this study by its identifier: NCT01320839

Canada, Nova Scotia
Capital Health
Halifax, Nova Scotia, Canada, B3H 4K4
Sponsors and Collaborators
Nova Scotia Health Authority
Principal Investigator: Kim Parker, M.A.Sc. CDHA
  More Information

Responsible Party: Kim Parker, Rehabilitation Engineer, Capital District Health Authority, Canada Identifier: NCT01320839     History of Changes
Other Study ID Numbers: CDHA-RS/2011-004
Study First Received: February 23, 2011
Last Updated: March 6, 2014

Additional relevant MeSH terms:
Gait Disorders, Neurologic
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on May 25, 2017