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Clinical Trials/NCT01320839
NCT01320839
Completed
N/A

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

Nova Scotia Health Authority1 site in 1 country21 target enrollmentMarch 2011

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
Nova Scotia Health Authority
Enrollment
21
Locations
1
Primary Endpoint
Velocity
Status
Completed
Last Updated
12 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
March 2011
End Date
November 2013
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kim Parker

Rehabilitation Engineer

Nova Scotia Health Authority

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Velocity

Time Frame: up to one week

walking velocity

Secondary Outcomes

  • trunk acceleration(up to one week)
  • Step length variability(up to one week)
  • The Berg Balance Scale(up to one week)

Study Sites (1)

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