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

NCT01320839 | Completed

• 1 other identifier: CDHA-RS/2011-004
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Gait, Hemiplegic

Outcome Measures

Primary Outcomes (1)

• Velocity

  walking velocity

  up to one week

Secondary Outcomes (3)

• trunk acceleration

  up to one week

• Step length variability

  up to one week

• The Berg Balance Scale

  up to one week

Study Arms (1)

Stroke

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Capital Health

Halifax, Nova Scotia, B3H 4K4, Canada

Location

MeSH Terms

Conditions

Stroke; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kim Parker, M.A.Sc.

  CDHA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rehabilitation Engineer

Study Record Dates

• First Submitted: February 23, 2011
• First Posted: March 23, 2011
• Study Start: March 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: March 7, 2014

Record last verified: 2014-03

Locations

CA (1)