Effects of an Ankle-Foot Orthosis on Gait While Performing an Attention Demanding Task
This study has been completed.
Information provided by (Responsible Party):
Kim Parker, Capital District Health Authority, Canada
First received: February 23, 2011
Last updated: March 6, 2014
Last verified: March 2014
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.
||Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
||Effects of an Ankle-Foot Orthosis on Gait While Performing an Attention Demanding Task in People With Poststroke Hemiplegia
Primary Outcome Measures:
- Velocity [ Time Frame: up to one week ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- trunk acceleration [ Time Frame: up to one week ] [ Designated as safety issue: No ]
trunk acceleration during walking
- Step length variability [ Time Frame: up to one week ] [ Designated as safety issue: No ]
variability of right and left step length during walking
- The Berg Balance Scale [ Time Frame: up to one week ] [ Designated as safety issue: No ]
Functional balance measured using the Berg Balance Scale short form.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||November 2013 (Final data collection date for primary outcome measure)
People who have had a stroke and have an ankle-foot orthosis.
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).
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
People who have had a hemiplegic stroke and have an ankle-foot orthosis.
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01320839
|Halifax, Nova Scotia, Canada, B3H 4K4 |
Capital District Health Authority, Canada
||Kim Parker, M.A.Sc.
No publications provided
||Kim Parker, Rehabilitation Engineer, Capital District Health Authority, Canada
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 23, 2011
||March 6, 2014
||Canada: Health Canada
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 17, 2014
Gait Disorders, Neurologic
Central Nervous System Diseases
Nervous System Diseases
Signs and Symptoms