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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01320839
• Other study ID #: CDHA-RS/2011-004
• Status: Completed
• Phase: N/A
• First received: February 23, 2011
• Last updated: March 6, 2014
• Start date: March 2011
• Est. completion date: November 2013

Study information

• Verified date: March 2014
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Crossover, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Gait, Hemiplegic
• Stroke

Locations

Country	Name	City	State
Canada	Capital Health	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Velocity	walking velocity	up to one week	No
Secondary	trunk acceleration	trunk acceleration during walking	up to one week	No
Secondary	Step length variability	variability of right and left step length during walking	up to one week	No
Secondary	The Berg Balance Scale	Functional balance measured using the Berg Balance Scale short form.	up to one week	No