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

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Gait, Hemiplegic

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).

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 4K4
      • Capital Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Stroke; People who have had a stroke and have an ankle-foot orthosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Velocity	walking velocity	up to one week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
trunk acceleration	trunk acceleration during walking	up to one week
Step length variability	variability of right and left step length during walking	up to one week
The Berg Balance Scale	Functional balance measured using the Berg Balance Scale short form.	up to one week

Collaborators and Investigators

• Sponsor: Nova Scotia Health Authority
• Investigators: Principal Investigator: Kim Parker, M.A.Sc., CDHA

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: February 23, 2011
• First Submitted That Met QC Criteria: March 21, 2011
• First Posted (Estimate): March 23, 2011

Study Record Updates

• Last Update Posted (Estimate): March 7, 2014
• Last Update Submitted That Met QC Criteria: March 6, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Gait Disorders, Neurologic
• Other Study ID Numbers: CDHA-RS/2011-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No