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

Completed

• Conditions: Gait, Hemiplegic; Stroke

• Registration Number: NCT01320839
• Lead Sponsor: Nova Scotia Health Authority

Brief Summary

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.

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 Timeline

• Study First Submitted: 2011-02-23
• Study Start: 2011-03
• Study First Submitted QC: 2011-03-21
• Study First Posted: 2011-03-23
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-06
• Last Update Posted: 2014-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Velocity	up to one week	walking velocity

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Capital Health; 🇨🇦 Halifax, Nova Scotia, Canada