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CompletedNCT01320839Updated Mar 7, 2014

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

An observational study in Stroke and Gait, Hemiplegic, sponsored by Nova Scotia Health Authority. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-03-07.

Sponsored by Nova Scotia Health Authority · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Cross-sectional
Enrollment
21
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Stroke
  • Gait, Hemiplegic
03

In context

Gait Disorders, Neurologic

327 studies on the registry are indexed under Gait Disorders, Neurologic; 54 are open to participants now.

This study's enrollment of 21 is below the median of 54 across 75 observational studies indexed under Gait Disorders, Neurologic.

Browse Gait Disorders, Neurologic studies →

Lead sponsor

Nova Scotia Health Authority is the lead sponsor of 255 studies on the registry; 76 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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.
05

Study design

Observational model
Case-crossover
Time perspective
Cross-sectional
Enrollment
21 participants (actual)

Groups and cohorts

  • Stroke

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

06

What researchers measure

Primary outcomes

  1. Velocity

    walking velocity

    Time frame: up to one week

Secondary outcomes

  1. trunk acceleration

    trunk acceleration during walking

    Time frame: up to one week

  2. Step length variability

    variability of right and left step length during walking

    Time frame: up to one week

  3. The Berg Balance Scale

    Functional balance measured using the Berg Balance Scale short form.

    Time frame: up to one week

07

Study locations

1 site
  • Capital Health
    Halifax, Nova Scotia B3H 4K4, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01320839
Lead sponsor
Nova Scotia Health Authority
Responsible party
Kim Parker (Rehabilitation Engineer, Nova Scotia Health Authority) — Principal investigator
First posted
Mar 23, 2011
Start date
Mar 2011
Primary completion
Nov 2013
Completion
Nov 2013
Last update
Mar 7, 2014

Study contacts

Kim Parker, M.A.Sc.
principal investigator · CDHA

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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