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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kim Parker, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01320839
First received: February 23, 2011
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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.


Condition
Stroke
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 Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Velocity [ Time Frame: up to one week ] [ Designated as safety issue: No ]
    walking velocity


Secondary Outcome Measures:
  • trunk acceleration [ Time Frame: up to one week ] [ Designated as safety issue: No ]
    trunk acceleration during walking

  • Step length variability [ Time Frame: up to one week ] [ Designated as safety issue: No ]
    variability of right and left step length during walking

  • The Berg Balance Scale [ Time Frame: up to one week ] [ Designated as safety issue: No ]
    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)
Groups/Cohorts
Stroke
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

People who have had a hemiplegic stroke and have an ankle-foot orthosis.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01320839

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

No publications provided

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

ClinicalTrials.gov processed this record on October 30, 2014