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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01320839
Other study ID # CDHA-RS/2011-004
Secondary ID
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


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
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